Reported trial results for Myeloma
Every Myeloma trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
186 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT04504825 · results posted 2 July 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04504825) enrolled 125 participants in total — 84 received CAEL-101 (an investigational drug) alongside standard treatment for their underlying blood disorder, while 41 received a placebo alongside the same standard treatment. The trial was primarily measuring two things: how long participants survived overall, and how often they were hospitalised for heart-related reasons. These two outcomes were combined into a single scoring method (called a "win ratio") that compares pairs of participants to see whose outcome was relatively better. The trial also tracked unintended medical events that occurred during treatment, changes in participants' self-reported quality of life using a heart-failure questionnaire, how far participants could walk in six minutes, deaths from any cause, and the rate of heart-related hospitalisations. The reported data shows that for the main combined survival-and-hospitalisation measure, the overall win ratio was reported as 0.95 (a number greater than 1 would have favoured CAEL-101 over placebo; a number less than 1 does not). Separate win ratio figures of 1.57 and 0.71 were also reported, though the trial data as submitted does not clearly label which subgroups or time points these correspond to. For unintended medical events during treatment, the reported data shows all 84 participants in the CAEL-101 group and 40 out of 41 in the placebo group experienced at least one such event. Regarding deaths from any cause during the study period, 46 deaths were recorded in the CAEL-101 group and 22 in the placebo group, though context for these figures (such as length of follow-up) is needed for meaningful interpretation and was not broken down further in the submitted data. For heart-related hospitalisations, the reported rate was 0.93 episodes per year in the CAEL-101 group compared with 1.73 per year in the placebo group overall, with variation across subgroups also reported. For the secondary measures, the reported data shows that scores on the heart-failure quality-of-life questionnaire (where higher scores mean better wellbeing, on a scale of 0–100) changed from baseline by around 20–22 points in the CAEL-101 group and around 4–11 points in the placebo group across reported subgroups. For the six-minute walk test, changes from baseline in distance walked ranged from approximately 33–42 metres in the CAEL-101 group and approximately 26–58 metres in the placebo group — the reported figures varied across the subgroups listed and the data as submitted does not specify which subgroups each figure belongs to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT07150104 · results posted 25 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom received a combination of four medicines: belantamab mafodotin (at a dose of 0.5 mg/kg), nirogacestat, pomalidomide, and dexamethasone. The trial was studying this combination in a dose-exploration phase (to assess tolerability of the dose) and was measuring things like unwanted medical events experienced by participants, changes in blood test results, and how many participants' disease responded to the treatment combination. The reported data shows that all 14 participants experienced at least one adverse event (an unwanted medical occurrence during the trial). Of the 11 participants considered evaluable for dose-limiting toxicities — meaning serious unwanted effects serious enough to potentially require a change in dosing — 2 were reported to have experienced such an event. Changes in blood test results (both for blood cell counts and chemistry markers) were recorded across various participants, with the numbers varying depending on the specific test and severity level measured. For the primary outcome measuring overall response rate in the later confirmation phase of the trial, no data was reported. However, the secondary outcome measuring overall response rate during the dose-exploration phase reported that 57% of participants had a confirmed partial response or better to the treatment combination. It is worth noting that 7 of the 14 participants did not complete the trial, though the reasons were not detailed in the submitted data. The overall response rate figure for the main confirmation phase of the trial was not reported in the data submitted to ClinicalTrials.gov, so that result cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT07217119 · results posted 25 June 2026
According to the results reported on ClinicalTrials.gov, this trial looked at two investigational medicines — belantamab mafodotin and feladilimab — given together in different dose combinations to people with a type of blood cancer called multiple myeloma. A total of 25 people took part across three groups: 9 people received the lower dose of belantamab mafodotin (1.9 mg/kg) combined with the lower dose of feladilimab (8 mg); 10 people received the higher dose of belantamab mafodotin (2.5 mg/kg) with the lower feladilimab dose (8 mg); and 6 people received the higher dose of belantamab mafodotin (2.5 mg/kg) with a higher feladilimab dose (24 mg). The trial was primarily measuring side effects and safety-related events, including serious reactions called dose-limiting toxicities (that is, reactions severe enough to limit how much of the medicine could be given). The reported data shows that all 25 participants who started the trial experienced at least one adverse event (an untoward medical occurrence during the study) — 9 out of 9 in the first group, 9 out of 10 in the second group, and 6 out of 6 in the third group. Regarding dose-limiting toxicities specifically, 1 participant in the first group and 1 participant in the second group met the criteria for these serious reactions, while none in the third group did. The reported data also shows changes in blood test results (such as blood cell counts and chemistry markers) for small numbers of participants across all three groups, with most changes recorded as mild to moderate in severity. It is worth noting that the figures for one of the primary outcome measures — the overall response rate from the cohort expansion phase — were not reported in the data submitted. For the secondary outcome of overall response rate during the dose expansion phase (meaning the proportion of participants whose disease showed at least a partial response based on set criteria), the reported data shows 44% in the first group, 50% in the second group, and 67% in the third group. These are the proportions of participants whose disease markers met specific pre-defined response thresholds, as assessed by the treating doctors. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT07217184 · results posted 25 June 2026
According to the results reported on ClinicalTrials.gov, this trial tested two different medicines given together — belantamab mafodotin and isatuximab — in people with a blood cancer called multiple myeloma. Thirty participants in total were enrolled, split evenly across three groups of 10, each receiving a different dose or dosing schedule of belantamab mafodotin alongside isatuximab. The trial was primarily measuring safety-related events, including whether serious dose-related reactions (called "dose-limiting toxicities") occurred, as well as tracking any unwanted medical events (called "adverse events") and changes in blood test results during treatment. The reported data shows that all 10 participants in each of the three groups experienced at least one adverse event of some kind. Regarding the more serious dose-limiting toxicities, 2 out of 10 participants in the group receiving the higher dose every four weeks experienced one, compared to 0 out of the evaluable participants in the lower-dose every-eight-weeks group, and 1 out of the evaluable participants in the higher-dose every-eight-weeks group. Changes in blood test results (such as white blood cell counts and chemistry markers) were also tracked and varied across the groups, with the most common shifts being mild to moderate in grade. For one primary outcome — the overall response rate during a planned expansion phase of the trial — no data was reported. The reported data for a secondary outcome shows that the proportion of participants whose disease showed a confirmed response (meaning markers of myeloma reduced by a meaningful amount) was 20% in the higher-dose every-four-weeks group, and 30% in each of the two every-eight-weeks groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT04512235 · results posted 17 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 281 people in total — 187 received the study drug CAEL-101 alongside standard treatment for their underlying blood disorder, and 94 received a placebo (an inactive dummy treatment) alongside the same standard treatment. The trial was primarily looking at two things: how long participants survived, and how often they needed to be admitted to hospital for heart-related reasons. It also looked at participants' quality of life, how far they could walk in six minutes, and overall death rates. The reported data shows that the main result was expressed as a "win ratio" of 1.23. In simple terms, this means that when the researchers compared pairs of participants — one from each group — the CAEL-101 group came out ahead slightly more often than the placebo group when looking at survival and heart-related hospital admissions combined. Regarding heart-related hospitalisations specifically, the reported rate was approximately 0.36 per year in the CAEL-101 group compared with 0.48 per year in the placebo group. For deaths during the study period, 44 participants in the CAEL-101 group and 30 in the placebo group passed away. On the quality-of-life questionnaire (scored 0–100, higher meaning better), both groups reported improvements from their starting scores, though the reported numbers varied across different time points. For the six-minute walk test, both groups also showed changes from their starting distances, with figures varying across time points. All 187 participants in the CAEL-101 group and all 94 in the placebo group experienced at least one adverse event (any unwanted medical occurrence during the study period). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT07150091 · results posted 16 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 10 in a lower-dose group receiving 0.5 mg/kg of belantamab mafodotin combined with nirogacestat, lenalidomide, and dexamethasone, and 10 in a higher-dose group receiving 1.0 mg/kg of the same combination. The trial was studying a four-drug combination for what appears to be a blood cancer (based on the response criteria used), and was looking at two things: first, a "dose exploration" phase to understand safety signals and side effects at each dose level, and second, a "confirmatory expansion" phase to look at how many participants showed a measurable response to treatment. The reported data shows that in the dose exploration phase, 1 out of 10 participants in the lower-dose group and 2 out of 10 in the higher-dose group experienced what are called "dose-limiting toxicities" — that is, side effects considered serious enough during the early phase of the trial to potentially affect how the dose is set going forward. In terms of general adverse events (any unwanted medical occurrence noted during the trial), 9 out of 10 participants in the lower-dose group and all 10 participants in the higher-dose group had at least one such event recorded. For the response measure in the dose exploration phase — meaning the proportion of participants whose disease showed at least a partial response — the reported data shows 40% in the lower-dose group and 70% in the higher-dose group. The primary outcome measure for the confirmatory expansion phase (the overall response rate for that phase) had no data reported. Blood test results showing changes in various measurements over time were also recorded, though those figures varied across different parameters and groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04824794 · results posted 19 May 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04824794) tested an investigational treatment called GEN3014 across several groups of people with different blood cancers — including relapsed or refractory multiple myeloma (a blood cancer affecting plasma cells), relapsed or refractory acute myeloid leukaemia (a type of blood cancer), and relapsed or refractory diffuse large B-cell lymphoma (an aggressive form of lymphoma). In total, 131 people took part across all groups. The trial had two main phases: a dose-escalation phase (where researchers gradually increased the dose to find an appropriate level) and an expansion phase (where specific doses were tested in larger groups, including a comparison with an existing treatment called daratumumab). No participants were recorded as having formally "completed" the trial in the reported data. The reported data shows that during the dose-escalation phase, one participant — in the highest myeloma dose group (24 mg/kg) — experienced what the trial defined as a dose-limiting toxicity (that is, a side effect severe enough to limit how much of the drug could be given). All other dose groups recorded zero such events. Every participant in the dose-escalation phase experienced at least one adverse event (an unwanted medical event that occurred during the trial). For the main response measure — the proportion of participants whose disease showed at least a partial response — the reported figures were: 54.5% in the myeloma expansion group receiving GEN3014, and 50.0% in the lymphoma expansion group receiving GEN3014. In the comparison expansion group, 51.2% of participants receiving daratumumab and 51.1% of those receiving GEN3014 showed at least a partial response. The trial also measured how much of the drug was present in participants' blood at various points; these figures showed that blood levels of GEN3014 generally rose as the dose increased, though the detailed breakdown of all blood-level measurements across every sub-group was not fully reported for every time point in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT07084896 · results posted 6 May 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 106 participants across seven different treatment groups. The trial was studying two drugs — belantamab mafodotin and nirogacestat — used together or separately in people with a blood cancer called multiple myeloma. The trial had two phases: a dose-exploration (DE) phase, where researchers tested different dose combinations across five groups (35 participants in total), and a cohort-expansion (CE) phase, where two larger groups (34 and 37 participants respectively) received doses selected from the earlier phase. The reported data shows that in the dose-exploration phase, one of the primary things being tracked was the number of participants who experienced a "dose-limiting toxicity" (DLT) — meaning a side effect serious enough that it would signal the dose was too high. In the 0.95 mg/kg belantamab mafodotin group, 1 out of 8 evaluable participants had a DLT; in the 1.9 mg/kg group, 2 out of 3 evaluable participants had a DLT; and in the remaining three dose groups, 0 participants had a DLT. The trial also tracked undesirable medical events (called adverse events) during treatment — all 10 participants in both the 0.95 mg/kg and the 1.0 mg/kg groups, and all 10 in the 1.4 mg/kg group, had at least one such event recorded, as did all 4 in the 1.9 mg/kg group. Blood test changes over time were also recorded across all groups, though the full breakdown of those figures was only partially reported in the submitted data. The reported data also shows that in the cohort-expansion (CE) phase, the primary measure was the "overall response rate" — the percentage of participants whose disease showed at least a partial response based on set criteria. In the group receiving 0.95 mg/kg belantamab mafodotin plus nirogacestat, the reported response rate was 29%. In the group receiving 2.5 mg/kg belantamab mafodotin alone, it was 38%. In the dose-exploration phase, response rates reported as a secondary measure varied considerably by group: 60% in the 0.95 mg/kg combination group, 0% in the 1.9 mg/kg group, 40% in the 1.0 mg/kg group, 50% in the 1.4 mg/kg group, and 0% in the fifth group (which had only one participant). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02316106 · results posted 23 April 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT02316106) involved 123 people with a condition called smouldering multiple myeloma — a form of the disease that has not yet caused symptoms. Participants were divided equally into three groups of 41, each receiving a different treatment schedule using the drug daratumumab: a long intensive schedule (Arm A), an intermediate schedule (Arm B), and a short intensive schedule (Arm C). The trial was measuring things like how many people achieved a complete response (meaning no detectable signs of the disease in blood, urine, or bone marrow), how quickly the disease progressed or people died, and how long people went before needing their next treatment. The reported data shows that for the primary measure of complete response, 4.9% of people in Arm A, 12.2% in Arm B, and 0% in Arm C reached that level. For the rate of disease getting worse or death (measured as events per year of follow-up), the figures were very similar across all three groups: 0.096 for Arm A, 0.102 for Arm B, and 0.109 for Arm C. For the broader measure of any meaningful response to treatment (partial response or better), the reported figures were 56.1% in Arm A, 56.1% in Arm B, and 37.5% in Arm C. The reported data shows that the estimated time before the disease progressed (known as progression-free survival) was around 81 months for Arm A, 84 months for Arm B, and 81 months for Arm C. For time until participants needed their next treatment, a specific number was only reported for Arm C (76.3 months); figures for Arms A and B were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02773030 · results posted 20 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT02773030) enrolled a total of around 500 participants across a large number of different treatment groups, organised into several "cohorts" (labelled A through K). Each cohort tested a different drug combination or dose level. The trial was primarily measuring two things: first, how many participants in the early dose-finding phase experienced what researchers call a "dose-limiting toxicity" — meaning a side effect serious enough to cap or stop increasing the dose; and second, the "overall response rate" in two specific cohorts (Cohort D and Cohort H2), which is the percentage of participants whose cancer showed at least a partial reduction according to standard measurement criteria. The reported data shows that in the dose-finding phase, the number of participants who experienced a dose-limiting toxicity was very low across most groups — zero in the majority of treatment arms, with one participant recorded in each of three groups (Cohort A: Treatments 4, 5, and 6). For the overall response rate, the reported figures were 26.2% for Cohort D and 20.0% for Cohort H2. This means that, according to the submitted data, roughly one in four participants in Cohort D and one in five in Cohort H2 met the criteria for at least a partial response. A secondary outcome — the number of participants who experienced treatment-related adverse events (unwanted medical occurrences during the study) — was also measured, though the full breakdown of those numbers was not completely available in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04850846 · results posted 9 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04850846) enrolled 60 people in total — 30 in a group receiving metformin (a medication commonly used for diabetes) and 30 in a group receiving a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in a protein in the blood called M-protein, which is associated with a type of blood condition. By the end of the study, 22 people in the metformin group and 23 in the placebo group had completed the trial, meaning 8 and 7 people respectively did not finish. The reported data shows that, for the main outcome being measured — the change in M-protein levels in the blood — the metformin group had an average change of **−3.2%** (a slight decrease), while the placebo group had an average change of **+7.7%** (an increase). These numbers simply describe the direction and size of the change recorded in each group during the trial period. For the six secondary outcomes — which included measures such as other blood proteins, haemoglobin levels, blood sugar markers, and changes in certain cell types — the reported data shows that no results were submitted to ClinicalTrials.gov, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03301220 · results posted 23 December 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03301220) enrolled 390 people in total — 196 in a group receiving active monitoring only (meaning they were closely watched but not given the study drug), and 194 in a group receiving a medicine called daratumumab SC (given by injection under the skin). The trial was studying people with a condition that can be a forerunner to multiple myeloma (a type of blood cancer), and the main thing being measured was "progression-free survival" — that is, how long participants went without their condition worsening into active multiple myeloma or without dying from any cause. The reported data shows that for the active monitoring group, the median progression-free survival was approximately 41.46 months — meaning that, at the midpoint of results for that group, it took roughly 41 and a half months before half of the participants had experienced worsening of their condition or death. For the daratumumab SC group, the equivalent figure was listed as "NA" (not available), which typically means that during the study period enough participants in that group had not yet reached that milestone for a median figure to be calculated. For the secondary outcome measures — including time to biochemical progression, overall response rate, complete response rate, time to needing first-line treatment for multiple myeloma, and a second progression-free survival measure — no numerical results were reported in the submitted data, so those figures are not available to describe here. It is worth noting that the trial records show zero participants listed as having formally "completed" the study in either group, and all participants are recorded as "not completed," though the reasons for this are not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03317899 · results posted 17 December 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 77 people in total — 38 in one group who received a stem cell transplant along with a drug called tbo-filgrastim (a medicine given after transplant to encourage the body to make new blood cells), and 39 in a second group who received the stem cell transplant without that drug. The trial was mainly looking at how many days it took before each person was considered ready to leave hospital after their transplant. It also tracked several other measurements, including how long it took for two types of blood cells — white cells (neutrophils) and platelets — to recover to target levels, and how many days participants spent with fever during their hospital stay. The reported data shows that, on average, people in the tbo-filgrastim group were recorded as ready for discharge after 11 days, compared with 15 days in the group without the drug. For white blood cell recovery, the reported median (meaning the middle value when all results are lined up in order) was 11 days in the tbo-filgrastim group and 13 days in the comparison group. Platelet recovery took a median of 19 days in both groups. Regarding a complication called engraftment syndrome — a reaction the body can have during the recovery process — it was reported in approximately 48.6% of participants in the tbo-filgrastim group and 60% in the other group. The median number of days with a fever and low white blood cell count was reported as 2 days in the tbo-filgrastim group and 4 days in the comparison group. The data for overall febrile (feverish) days during the hospital stay was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05405166 · results posted 14 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05405166) enrolled 531 adults with a blood cancer called multiple myeloma. Participants were randomly assigned to one of two groups: 268 people received isatuximab given through a drip into a vein (intravenous, or "IV"), combined with two other medicines (pomalidomide and dexamethasone); and 263 people received the same isatuximab combination but delivered as an injection under the skin (subcutaneous, or "SC"). The trial was measuring how often patients responded to treatment, how much of the drug was present in the blood at key time points, and patients' satisfaction with the way the medicine was given. The reported data shows that the proportion of participants whose disease showed a measurable response — meaning tumour markers fell by at least half — was 70.5% in the IV group and 71.1% in the SC group. Within those responders, a deeper level of response (a drop of 90% or more in tumour markers) was seen in 45.9% of the IV group and 46.4% of the SC group. The trial also measured the amount of isatuximab remaining in the blood just before a dose was due (a measure of how much drug was "on board" between doses): at a steady state around the sixth treatment cycle, the IV group had an average of 340 micrograms per millilitre, while the SC group had 499 micrograms per millilitre. Regarding reactions at the time of administration, 25.0% of participants in the IV group experienced a reaction, compared with 1.5% in the SC group. When asked about their satisfaction with the injection method, 53.4% of the IV group and 70.0% of the SC group reported being "satisfied" or "very satisfied." The reported data also notes that zero participants in either group were recorded as having "completed" the study at the time of data submission, which may reflect that the trial was still ongoing or that completion was defined in a specific way not fully detailed in the data available — this figure was not further explained in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04439149 · results posted 31 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04439149) enrolled 24 participants who received the study treatment, a drug called GSK2636771. Of those, 23 began the treatment as planned, and 22 were considered eligible and treated for the purposes of analysis. No participants were recorded as having formally completed the study. The trial was measuring how cancer tumours responded to the treatment, and how long participants went without their disease getting worse. The reported data shows that for the primary goal — the rate at which tumours showed a measurable shrinkage or disappearance (called the "objective response rate") — the figure reported was 0%, meaning none of the analysable participants met the criteria for a complete or partial tumour response. For the secondary outcomes, the reported data shows that around 4.8% of participants had not experienced disease progression or death at the six-month mark. The middle point of the time participants went without disease progression or death (called "median progression-free survival") was reported as 1.8 months, meaning half of participants reached that point sooner and half later. It is worth noting that this was a relatively small group of participants, and the results as submitted reflect what was observed in this specific trial population only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05961215 · results posted 27 October 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 participants, all of whom used the Penguin Cold Cap — a device worn during chemotherapy that cools the scalp with the aim of reducing hair loss. Thirty participants completed the trial and one did not. The trial was measuring how much hair loss participants experienced while using the cap, and also asked participants to rate how beneficial they felt the scalp cooling was for them. The reported data shows that of the 30 participants counted in the primary outcome, 26 were recorded as having less than 50% hair loss (meaning hair loss was not obvious from a distance), and 4 were recorded as having 50% or more hair loss (meaning it was more readily noticeable). No participants were recorded in the remaining categories. The trial had set a target of at least 75% of participants experiencing less than 50% hair loss — the reported data shows 26 out of 30 participants (roughly 87%) fell into that lower hair-loss category. For the secondary outcome — where participants rated the benefit they felt from scalp cooling on a questionnaire — the reported data shows 2 participants reported no benefit, 8 reported some level of benefit, 6 reported a higher level of benefit, and 13 reported the highest level of benefit (described as substantial benefit). The exact labels for each step on the questionnaire scale were not included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05064358 · results posted 7 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05064358) enrolled 177 participants across five groups, all receiving different doses and schedules of a medicine called belantamab mafodotin. The groups varied by dose (either 2.5 mg per kilogram of body weight, or 1.9 mg/kg) and how often the dose was given (every 3 weeks or every 6 weeks). The trial was primarily measuring how often participants developed moderate-to-severe eye changes — specifically changes to the cornea (the clear front surface of the eye) that also affected their vision — as graded on a standardised scale called the KVA scale. The reported data shows that, for the primary outcome, the percentage of participants who developed moderate or worse corneal and vision changes (Grade 2 or above on the KVA scale) was 64% in the higher-dose every-3-weeks group, 40% in the lower-dose every-3-weeks group, 44% in the higher-dose every-6-weeks group, and 38% in the lower-dose every-6-weeks group. A fifth group (Arm E, lower dose every 6 weeks, with dosing guided by eye symptom assessments) was included in the secondary measurements but was not part of the primary outcome comparison. For secondary outcomes, the reported data shows that the number of participants who experienced any corneal event up to week 16 ranged from 12 to 26 across the five groups. Regarding dose management due to corneal events, the reported data shows that dose interruptions or delays affected between 28% and 59% of participants depending on the group, and dose reductions affected between 23% and 35%. The median length of dose delays ranged from 18 days to 60 days across the groups. For the most severe corneal events (Grade 3 and above on a separate scale called CTCAE), the reported rate in most groups was very low, and Grade 4 and 5 events were reported as zero across all groups where data was available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06063603 · results posted 18 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06063603) enrolled 59 people across three groups: 51 patients receiving pain management (Group 1), 5 healthcare providers who delivered the intervention (Group 2), and 3 medical oncology providers (Group 3). The trial was designed to test whether a pain management intervention was *feasible* (could it be delivered as intended?), *acceptable* (were participants satisfied with it and did they engage with their care team?), and *useful* (did participants find it helpful, feel confident, and find it easy to use?). Of the 51 patients who started, 41 completed the main visits and 35 completed the final survey. The reported data shows the following for the patient group. On feasibility — meaning whether key parts of the program were actually delivered — the numbers reported across the different components were 41, 17, 11, 5, 27, and 16 participants, though the specific component each number refers to was not described in detail in the submitted data. On acceptability of interaction with the care team, the reported participant counts across frequency categories were 0, 1, 18, 16, and 0; and for satisfaction, 0 participants reported being dissatisfied while 35 reported being satisfied. On usefulness, participants rated helpfulness, confidence, and ease of use on a 1-to-5 scale (1 being least positive, 5 being most positive), and the spread of responses across those categories was reported as counts of participants — for example, on ease of use, 15 participants chose the highest rating of "extremely easy" for one item, while no participants chose the lowest ratings of "very difficult." The reported data shows that while numbers were submitted for each scale category, the full labels for every individual question and category were not included in the structured data provided to ClinicalTrials.gov, so a complete item-by-item breakdown cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03078452 · results posted 8 September 2025
According to the results reported on ClinicalTrials.gov, this trial involved 100 people in total — 50 in each group. All 100 participants completed the study. The trial was comparing two different tools used to take a bone marrow biopsy (a procedure where a small sample of bone marrow is removed for testing): one group had their biopsy taken using a power drill device, and the other group had theirs taken using a traditional hand-held needle called a Jamshidi needle. The trial measured the size of the tissue sample collected, how long the procedure took, and how much pain participants reported. The reported data shows that, on average, the power drill produced a bone marrow sample measuring 14 millimetres in length, compared to 9.5 millimetres for the traditional needle. For procedure time, the reported data shows the power drill group's procedure took a median of 7 seconds, while the traditional needle group's took a median of 10.5 seconds. Pain was measured on a scale of 0 to 10 (where 0 means no pain and 10 means the worst possible pain). The reported data shows several pain scores recorded at different points during and after the procedure; the scores for both groups were low and appeared similar across time points, ranging from 0.18 to 1.62 for the power drill group and 0.26 to 1.62 for the traditional needle group. No further breakdown of when each pain score was measured was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06400251 · results posted 26 August 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called ipatasertib in people with certain cancers. A total of 35 people enrolled in the study, 34 began taking the treatment, and 32 were considered eligible and treated. Of those, 29 had their mutation status confirmed, and this smaller group of 29 people formed the main group used to assess the primary result. The trial was measuring how often tumours shrank or disappeared (called "objective response rate"), as well as how long people went without their disease getting worse (called "progression-free survival"). The reported data shows that, among the 29 participants whose mutation status was confirmed, 24.1% had their tumour shrink or disappear (a complete or partial response) during the study. For the secondary outcomes, the reported data shows that 46.8% of participants went at least 6 months without their disease getting worse or dying. The reported middle-point (median) time before the disease progressed or death occurred was 5.5 months, meaning roughly half of participants reached that point before 5.5 months and half after. It is worth noting that zero participants were recorded as having "completed" the study in the formal sense, which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05655546 · results posted 8 August 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05655546) involved 1,016 people in total — 495 in the intervention arm and 521 in the control arm. Nearly all participants finished the study (493 and 517 respectively). The trial was measuring two main things: how many participants ended up in hospital related to COVID-19 (tracked through insurance claims and self-reported surveys), and what the total cost of care for COVID-19 was in each group. The reported data shows that when it came to hospitalisations, the numbers recorded across different data sources varied between the two groups. In one data source, 59 people in the intervention arm and 58 in the control arm had a hospitalisation recorded; in another, 15 versus 22; in another still, 1 versus 13; and in a fourth count, 235 versus 192. The trial's results page lists these as separate measurements under the same outcome, but does not provide enough detail to explain what each individual count represents — for example, whether they reflect different time points or different data sources. For the cost of care outcome, the reported data shows an average cost of US$2,022 per person in the intervention arm compared with US$5,740 per person in the control arm. No further breakdown of these cost figures was reported in the submitted data. It is worth noting that this trial was conducted in the United States and used American insurance claims data, so the cost figures are in US dollars and reflect the American healthcare system. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05590377 · results posted 6 August 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05590377) looked at a combination of two medicines — modakafusp alfa and daratumumab — in people with a blood cancer called multiple myeloma. The trial had two stages: a Phase 1 dose-escalation stage, where researchers tested three different doses of modakafusp alfa (80 mg, 120 mg, and 240 mg) to understand how the body responded; and a planned Phase 2a stage, which aimed to narrow down the best dose. A total of 15 participants started the trial across the Phase 1 dose groups (3 at 80 mg, 6 at 120 mg, and 6 at 240 mg), and none were recorded as having completed the study. No participants were reported as having started in the Phase 2a groups. The reported data shows that in Phase 1, researchers tracked two key things: "dose-limiting toxicities" (DLTs — meaning unwanted medical events during the first treatment cycle that were considered serious enough to potentially limit how much of the drug could be given) and all treatment-emergent adverse events (unwanted medical occurrences that appeared after starting the study drug). According to the results, no DLTs were recorded in the 80 mg or 120 mg groups, while 1 out of 6 participants in the 240 mg group had a DLT. For adverse events broken down by severity, the reported data shows varying numbers of participants across the three dose groups experienced events of different severity levels, with the highest-severity events recorded in one participant in the 240 mg group. The Phase 2a primary outcome — the overall response rate (the proportion of participants whose disease showed a meaningful response) — was not reported, and the secondary outcomes measuring how the drug moved through the body over time also had no data reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02675452 · results posted 9 July 2025
According to the results reported on ClinicalTrials.gov, this trial tested an experimental drug called AMG 176 in people with either multiple myeloma (a type of blood cancer affecting plasma cells) or acute myeloid leukaemia (AML, a cancer of the blood and bone marrow). A total of 168 participants took part, spread across 29 different groups that each received different doses or dosing schedules of AMG 176 — some alone and some combined with other medicines such as azacitidine or itraconazole. The trial was a dose-finding study, meaning its main goal was to test different dose levels rather than to prove the treatment works. The primary outcome — the main thing the trial was designed to measure — was how many participants in each group experienced a "dose-limiting toxicity" (DLT), meaning a serious side effect considered severe enough to limit how much of the drug could be given. The reported data shows that across the vast majority of the 29 dosing groups, zero participants met the definition of a DLT. The secondary outcomes looked at how participants' cancers responded to treatment, using established medical criteria for both myeloma and AML. The reported data shows that across all groups assessed for tumour response, the number of participants recorded as having a measurable response was zero in every group reported. It is worth noting that this was an early-phase trial primarily designed to explore dosing, and the response data as submitted appears largely incomplete or not fully reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04181827 · results posted 20 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04181827) enrolled 419 people with multiple myeloma — 211 in the standard therapy group (receiving a drug combination called PVd or DPd) and 208 in the group receiving an experimental cell-based treatment called ciltacabtagene autoleucel (cilta-cel). The trial's main goal was to measure how long participants went without their disease getting worse or dying — a period known as "progression-free survival." The reported data shows that in the standard therapy group, the median progression-free survival — meaning the point at which half the participants in that group had experienced disease worsening or death — was approximately 11.79 months. For the cilta-cel group, the median progression-free survival is listed as "NA" (not yet reached), which typically means that at the time the data was collected, more than half of the participants in that group had not yet experienced disease progression or death, so a median figure could not be calculated. It is important to note that no participants were recorded as having "completed" the study, suggesting the trial was still ongoing when these results were submitted. The reported data shows that results for the secondary outcome measures — including rates of complete response, minimal residual disease negativity (a sensitive measure of how much disease remained detectable), and overall survival — were not provided in the submitted data and therefore cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01054196 · results posted 13 May 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people in total across two stages. The first stage (Phase 1) involved 22 participants split into six smaller groups, each receiving a different dose level of a drug called lenalidomide combined with another drug called melphalan. The aim was to find the highest dose of lenalidomide that could be added without causing unacceptable side effects — this is called the "maximum tolerated dose." The second stage (Phase 2) enrolled 30 participants and focused on measuring how long any positive response to the treatment lasted. The reported data shows that for the Phase 1 stage, the maximum tolerated dose figure was listed as "not available" — meaning a specific number was not reported in the submitted results. For the Phase 2 stage, the duration of response data shows the number of participants falling into different response-length categories: 7 participants, 6 participants, 10 participants, 4 participants, 1 participant, and 0 participants respectively, though the specific time ranges for each category were not included in the submitted data. For a secondary measure — a quality-of-life questionnaire scored from 0 to 148 (where a higher score means better quality of life) — the reported average scores across the groups ranged from approximately 69 to 85. The other secondary outcomes (overall response rate and overall survival) had no numerical results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06868667 · results posted 9 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06868667) enrolled 24 people with a form of blood cancer called multiple myeloma. Ten participants received a combination of three medicines — belantamab mafodotin, bortezomib, and dexamethasone — while 14 received a different three-medicine combination of daratumumab, bortezomib, and dexamethasone. The main thing the trial was measuring was "progression-free survival" — that is, how long participants went without their disease getting worse or dying. None of the 24 participants had completed the study at the time the results were submitted. The reported data shows that for the daratumumab combination group, the median progression-free survival — meaning the point at which half the participants in that group had experienced disease progression or death — was 11.1 months. For the belantamab mafodotin combination group, this figure was recorded as "NA" (not available), meaning a result could not be calculated from the data at the time of reporting, possibly because too few events had occurred in that group. For all of the secondary outcomes — including overall survival (how long participants lived), duration of response, and response rates — no numerical results were reported in the submitted data. It is worth noting that with only 24 participants across both groups, this was a very small study, and the data appears to have been submitted before all participants finished. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04892446 · results posted 2 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04892446) enrolled 36 people with multiple myeloma across three treatment groups: 15 people received magrolimab combined with daratumumab, 10 received magrolimab combined with pomalidomide and dexamethasone, and 11 received magrolimab combined with carfilzomib and dexamethasone. The trial was primarily measuring how often participants experienced certain serious side effects (called dose-limiting toxicities) and other unwanted medical events that occurred during treatment, as well as how many participants showed a measurable reduction in their cancer (called an objective response rate). The reported data shows that every participant across all three groups (100%) experienced at least one treatment-emergent adverse event — that is, any unwanted medical occurrence recorded from the first dose through to 70 days after the last dose. When looking at more serious, treatment-related side effects severe enough to be classified as "dose-limiting," the reported figures were approximately 17% of participants in both the magrolimab-plus-daratumumab group and the magrolimab-plus-pomalidomide-dexamethasone group, and 0% in the magrolimab-plus-carfilzomib-dexamethasone group. Regarding the cancer response measure, the reported data shows that 14.3% of participants in the first group, 20.0% in the second group, and 36.4% in the third group showed a confirmed measurable response to treatment. For the secondary outcome measuring how long any response lasted (duration of response), the data was not reported for any of the three groups. Blood concentration levels of magrolimab were measured at various time points and reported as ranging broadly across groups, but duration-of-response figures were listed as not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04439331 · results posted 8 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04439331) tested a drug called defactinib in people with certain cancers. A total of 35 people enrolled in the study, 33 of them began the treatment, and 30 had their eligibility and tumour mutation status fully confirmed. No participants were recorded as having "completed" the study in the conventional sense — this is common in cancer trials where participants leave the study early due to disease progression or other reasons. The reported data shows that the main thing researchers were measuring was the "objective response rate" — that is, the proportion of participants whose tumours showed a meaningful shrinkage (either a full or partial reduction in tumour size) according to standard medical criteria. Among the 30 fully confirmed and analysable participants, the reported objective response rate was approximately 3.2%, meaning roughly 1 out of those 30 participants had a tumour response of this kind. The reported data also shows that around 22.8% of participants had not experienced their cancer progressing (getting worse) or died at the 6-month mark. The middle point (median) for how long participants went without their disease progressing was reported as 1.9 months — meaning half of participants reached that point sooner and half later. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03748953 · results posted 21 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03748953) looked at a medicine called ixazomib in people with a blood cancer called multiple myeloma. The trial originally had two groups — one receiving ixazomib and one receiving a placebo (a dummy treatment) — but the design changed partway through. In total, 41 people started the ixazomib group across both phases of the trial, while 4 people were in the placebo group before that arm was removed. The trial was primarily measuring participants' physical health status, as well as tracking unwanted medical events (called adverse events) that occurred during treatment. The reported data shows that, among the ixazomib participants whose physical health was assessed using a standard five-point scale (where 0 means fully active and 5 means deceased), 34 out of 35 participants fell into one category and 1 participant fell into another — though the specific category labels for these two groups were not clearly distinguished in the submitted data. Regarding unwanted medical events, the reported data shows that 97% of ixazomib participants experienced at least one adverse event that emerged during treatment, and 31% experienced at least one serious adverse event (meaning something that, for example, required hospitalisation or was life-threatening). No participants were reported as having clinically significant changes in their laboratory test results based on the investigator's assessment. For the secondary outcomes, the reported data shows a median progression-free survival — that is, the middle-point estimate of how long it was before the disease worsened or death occurred — of 21.3 months in the ixazomib group. Overall survival (how long participants lived from their first dose) was listed as "not available" in the submitted data, meaning a final figure was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04484623 · results posted 18 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04484623) enrolled 302 people with multiple myeloma — 155 in one group and 147 in another. Participants were randomly assigned to receive either a combination of three medicines called belantamab mafodotin, pomalidomide, and dexamethasone, or a different three-medicine combination of pomalidomide, bortezomib, and dexamethasone. The trial's main goal was to measure "progression-free survival" — that is, how long participants went without their disease getting worse or without dying. The reported data shows that for the main outcome, progression-free survival was measured in months. For the pomalidomide, bortezomib, and dexamethasone group, the reported figure was 12.7 months. For the belantamab mafodotin, pomalidomide, and dexamethasone group, the value was listed as "NA" (not available), meaning a final number had not been reached or was not reportable at the time the data was submitted. Several other outcomes were also planned to be measured — including overall survival, how long responses lasted, and response rates — however, the reported data shows that no numerical results for these secondary outcomes were submitted to ClinicalTrials.gov at this time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02761187 · results posted 24 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02761187) enrolled a total of 4,253 people with multiple myeloma (a type of blood cancer) — 2,338 who had been newly diagnosed and 1,915 whose disease had come back or stopped responding to earlier treatment. The study was an observational registry, meaning it was designed to record and describe real-world information about participants rather than to test a new treatment. It tracked things like how many other health conditions participants had, how well they were able to carry out daily activities, and how "frail" (physically vulnerable) they were at different points in their treatment journey. The reported data shows that when it came to other health conditions (measured using a scoring tool called the Charlson Comorbidity Index), the largest group in both newly diagnosed and relapsed/refractory participants had a score of 1 (recorded as "not ill" on the scale) — 1,279 newly diagnosed and 1,064 relapsed/refractory participants fell into this category. Smaller numbers scored higher on that scale, indicating greater illness burden. For daily functioning (measured on a 0–5 scale where 0 means fully active and higher numbers mean more limitation), the reported data shows that 714 newly diagnosed and 710 relapsed/refractory participants scored 0 (fully active), while progressively fewer participants were recorded at higher limitation scores. For the frailty index, 517 first-line and 428 second-line participants were classified as "fit" (score of 0), with smaller numbers falling into "intermediate" or "frail" categories. The reported data for some primary outcome measures — including specific symptoms and sites of disease — contained no numerical results, so those figures were not reported to ClinicalTrials.gov and cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05986682 · results posted 3 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom had multiple myeloma (a type of blood cancer) and were being treated with a medicine called BLENREP (belantamab mafodotin). All 30 participants completed the study. The trial was an observational study — meaning it watched and recorded what happened during real-world treatment rather than comparing BLENREP against another treatment. It focused on tracking how the medicine was used in practice and how participants' disease responded. The reported data shows that the median (middle value) duration of treatment was 9.3 months, with a median of 6.5 treatment cycles received. Of the 30 participants, 26 discontinued (stopped) treatment during the study — 22 of those for reasons related to disease progression or lack of response, and 4 for other reasons. The reported data also shows that 27 out of 30 participants had at least one dose delay during their treatment, and 19 out of 30 had their dose reduced at some point. Regarding how participants' disease responded, no participants were reported as achieving a complete response (where signs of disease become undetectable), 11 achieved a very good partial response (a large reduction in disease markers), 9 achieved a partial response (a meaningful reduction), 9 had stable disease (no major change), and 1 had progressive disease (the disease worsened). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03187223 · results posted 30 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03187223) enrolled 120 people in total — 60 in each of two groups. All 120 participants completed the study with no drop-outs recorded. The trial was comparing two different chemotherapy conditioning regimens given before a procedure called an autologous stem cell transplant (ASCT), where a person's own stem cells are collected, stored, and returned to them after high-dose chemotherapy. One group (Arm A) received a drug called Melphalan alone, while the other group (Arm B) received a combination of Bendamustine and Melphalan. The main thing being measured was how many participants achieved a "complete remission" — meaning no detectable sign of disease — at 60 days after their transplant. The reported data shows that in Arm A (Melphalan alone), 31 out of 60 participants reached complete remission at 60 days, compared with 42 out of 60 in Arm B (Bendamustine plus Melphalan). For the secondary measures, the reported data shows that 36 out of 60 participants in Arm A and 43 out of 60 in Arm B experienced adverse events (unwanted side effects or reactions) during the study. The time taken for blood cell counts to recover after the high-dose chemotherapy was reported as 12 days on average for Arm A and 11 days for Arm B. At 12 months, 96% of participants in both groups were reported to be alive. Regarding the Quality of Life questionnaire (EORTC Q30), no results data was reported for this outcome measure on ClinicalTrials.gov, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05117008 · results posted 28 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05117008) enrolled just one participant, who received a treatment called Belantamab Mafodotin. The study was looking at a combination approach involving CAR-T cell therapy (a type of immune cell treatment) followed by Belantamab Mafodotin, and the main thing it was measuring was whether patients were still alive and free from their disease progressing 12 months after receiving the CAR-T infusion — but only counting from 90 days after that infusion. The reported data shows that one participant started the study and one participant completed it. For the primary outcome — the number of participants who were alive and progression-free at 12 months — the reported figure is one participant. Because only a single person was enrolled, it is not possible to draw any broader conclusions from these numbers alone. No secondary outcome data was reported in the submitted results. It is worth noting that trials with only one participant are extremely small, and the data submitted here is very limited. Any figures should be understood purely as a record of what happened in this single case, not as a general finding about the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03710603 · results posted 24 December 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03710603) enrolled 709 people in total — 354 in one group who received a three-drug combination called VRd (Velcade, Lenalidomide, and Dexamethasone), and 355 in a second group who received that same combination plus an additional medicine called Daratumumab (D-VRd). The trial was primarily measuring how long participants went without their condition getting worse or without dying — a measure known as "progression-free survival" (PFS). It also tracked several other things, including how many people showed no detectable signs of disease at a very sensitive level (called MRD negativity), how many people had any measurable response to treatment, and how many reached a full response. The reported data shows that, for the primary measure of progression-free survival, 103 out of 354 participants in the VRd group and 50 out of 355 participants in the D-VRd group experienced disease progression or death during the study period. For the secondary outcomes, the reported data shows that 168 out of 354 participants in the VRd group and 267 out of 355 in the D-VRd group achieved MRD negativity (meaning no detectable disease signs at a very fine level of testing). The overall response rate — the proportion of people who showed at least a partial response — was reported as 93.8% for the VRd group and 96.6% for the D-VRd group. The proportion who achieved a complete response or better was reported as 70.1% in the VRd group and 87.9% in the D-VRd group. The reported data shows that figures for two other secondary outcomes — survival after the next line of treatment and overall survival — were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04246047 · results posted 24 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04246047) enrolled 494 people in total — 243 in a group receiving a combination of belantamab mafodotin, bortezomib, and dexamethasone, and 251 in a group receiving daratumumab, bortezomib, and dexamethasone. The trial was studying people with a blood cancer called multiple myeloma, and its main goal was to measure "progression-free survival" — that is, how long participants went before their disease got worse or they passed away. The reported data shows that, for the main outcome measure, the belantamab mafodotin combination group had a median progression-free survival of 36.6 months, while the daratumumab combination group had a median of 13.4 months. (Median here simply means the midpoint — half of the people in each group reached that point sooner, and half took longer.) The trial also set out to measure a number of secondary outcomes — including how many people had a complete response, an overall response, or a clinical benefit, as well as how long responses lasted and how quickly they appeared — however, figures for all of these secondary outcomes were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02043847 · results posted 21 October 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total across three groups, each receiving a different dose of a radiation treatment called Total Marrow Irradiation (TMI) alongside a standard stem cell transplant procedure for multiple myeloma (a type of blood cancer). Three participants received the lowest dose (3 Gray), three received a middle dose (6 Gray), and six received the highest dose (9 Gray). The trial was primarily trying to find the highest dose of TMI that could be given without causing unacceptable harm — known as the "maximum tolerated dose." It also tracked how long participants went without their disease getting worse, and looked at how well the treatment appeared to be working based on established myeloma response criteria. The reported data shows that for the primary goal — identifying the maximum tolerated dose — the result was recorded as "not available" (NA), meaning a definitive answer to that question was not reported in the submitted data. Regarding the secondary measure of disease response and progression-free survival, the reported data shows that 1 out of 3 participants in the 3 Gray group, 1 out of 3 in the 6 Gray group, and 4 out of 6 in the 9 Gray group met the response criteria outlined in the study. It is also worth noting that very few participants were recorded as having "completed" the study — only 1 from the lowest-dose group — and the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04776018 · results posted 2 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04776018) enrolled 27 participants across five dosing groups in the Phase 1b, Part 1 stage of the study. The two later planned stages — Phase 1b Part 2 and Phase 2 — had no participants enrolled, meaning results from those stages were not available. The trial was testing combinations of an investigational drug called TAK-981 with another drug (mezagitamab) in people with a blood cancer called multiple myeloma. The Phase 1b portion was primarily looking at the types and severity of unwanted medical events (called adverse events) that occurred after participants started taking the study drugs, as well as how much of the drug was measurable in participants' blood. The reported data shows that across all five dosing groups, every participant who enrolled — all 27 people — experienced at least one treatment-emergent adverse event (that is, an unwanted medical occurrence that happened after starting the study drugs). When looking at more serious events graded as "severe or worse" (Grade 3 or higher), the reported numbers were: 0 out of 3 participants in the lowest-dose twice-weekly group; 3 out of 3 in the next twice-weekly group; 7 out of 10 in the once-weekly 90 mg group; 3 out of 3 in the twice-weekly 120 mg group; and 7 out of 8 in the once-weekly 120 mg group. The reported data also shows that dose-limiting toxicities — meaning unwanted events serious enough to potentially limit how much drug could be given — occurred in 1 participant each in three of the five groups (the 90 mg once-weekly, 120 mg twice-weekly, and 120 mg once-weekly groups), and none in the two lower-dose twice-weekly groups. For the Phase 2 portion, which was intended to measure how many participants responded to treatment, no results were reported as no participants were enrolled in that stage. The reported data also shows blood concentration levels of TAK-981, which reflect how much of the drug was present in participants' bloodstreams. The peak concentration measured (called Cmax — the highest level recorded in the blood) appeared to increase with higher doses: 225 nanograms per millilitre in the lowest-dose group, rising to 1,120 nanograms per millilitre in the highest twice-weekly dose group. Some additional concentration measurements were only partially reported, and figures for certain time points were listed as not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02939183 · results posted 26 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02939183) enrolled 61 participants across nine treatment groups. The study was testing different doses and formulations of an oral drug called oprozomib — either an immediate-release (IR) or a gradual-release (GR) tablet — given alone or in combination with one or two other medicines (dexamethasone and/or pomalidomide). The main things the trial was measuring were: how many participants experienced a "dose-limiting toxicity" (a side effect serious enough to limit how much of the drug could be given), what the highest tolerable dose was, and how many participants experienced any treatment-emergent adverse events (that is, any unwanted medical events that occurred after starting treatment). The reported data shows that across the eight main dosing groups, the number of participants who experienced a dose-limiting toxicity ranged from 0 to 2 per group. The highest tolerable daily dose (called the Maximum Tolerated Dose) for the immediate-release formulation combined with pomalidomide and dexamethasone was reported as 250 mg/day; for the gradual-release formulation in the same combination, this figure was listed as "not available" — meaning a maximum tolerated dose was not determined and the data was not reported for that group. Regarding treatment-emergent adverse events, the reported data shows these occurred in nearly all participants across the groups — for example, 4 out of 5 participants in the IR 150 mg + dexamethasone group, and 10 out of 11 in the IR 225 mg + pomalidomide + dexamethasone group. In the open-label roll-over group (7 participants), 7 experienced treatment-emergent adverse events and 4 experienced serious ones. For the secondary measures, the reported data shows how the drug moved through the body. The peak level of oprozomib measured in the blood (called Cmax) varied by dose and formulation — for instance, it ranged from around 118 ng/mL in the GR 150 mg + dexamethasone group up to around 1,020 ng/mL in the IR 225 mg + pomalidomide + dexamethasone group. The time it took to reach that peak level (Tmax) ranged from about 1 hour to just under 6 hours depending on the group and formulation, with the gradual-release tablets generally taking longer to reach their peak than the immediate-release tablets. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04999085 · results posted 25 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04999085) enrolled 16 participants, all of whom were placed in a single group receiving a supportive care programme. Fifteen of the 16 participants completed the study, while one did not. The trial was primarily measuring whether the programme was *feasible* — specifically, whether participants would actually attend at least one appointment with a specialist or supportive care service they were referred to. It also measured how satisfied participants were with the programme overall. The reported data shows that 50% of participants attended at least one of the appointments they were referred to — this was the main measure of feasibility. For the secondary measure, participant satisfaction was assessed using a 5-point scale (where 1 represents the least satisfaction and 5 represents the greatest). The reported data shows the average satisfaction score across participants was 4.4 out of 5. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01827137 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people with multiple myeloma (a type of blood cancer) who had previously undergone an autologous stem cell transplant — a procedure where a patient's own stem cells are collected and then returned to the body after high-dose treatment. Nineteen of the 20 participants completed the study. The trial was investigating a treatment called Galinpepimut-S (GPS), given alongside two other agents (Montanide and GM-CSF), and was primarily looking at whether the treatment prompted a particular type of immune response — that is, whether the body's immune cells reacted to a protein called WT1 that is associated with myeloma. The reported data shows that, at the primary measurement point (12–14 weeks after the first of six doses), 9 out of the 20 participants showed a measurable immune cell response to the WT1 protein. A later, post-hoc measurement (meaning it was analysed after the original plan) — taken after all 12 doses were given — reported that 12 out of the 20 participants showed this immune response. For the secondary outcomes, the reported data shows that the median time from stem cell transplant until the myeloma showed signs of progressing (known as progression-free survival) was 717 days. Overall survival — the time from stem cell transplant until death — was recorded as "not available" (NA), meaning that figure was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05228470 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05228470) enrolled a total of 38 people — 8 in an initial smaller Phase 1b portion and 30 in the larger Phase 2 portion. The trial was measuring two main things: first, in the Phase 1b group, whether certain serious side effects (called dose-limiting toxicities, or DLTs — meaning harmful reactions serious enough to limit how much of the treatment could be given) occurred; and second, across both groups, what proportion of participants showed a meaningful reduction in their cancer (called the Objective Response Rate, or ORR). The reported data shows that none of the participants were recorded as having formally "completed" the study in the way the trial defined completion, though all 38 were recorded as having started. The reported data shows that in the Phase 1b group, 1 out of 8 participants experienced a dose-limiting toxicity. For the main response measure (ORR — the percentage of participants whose disease showed a significant reduction according to standardised criteria assessed by an independent review panel), the reported figures were 37.5% in the Phase 1b group (3 out of 8 people), 53.3% in the Phase 2 group (roughly 16 out of 30 people), and 50.0% across both groups combined. For the secondary outcome measures — including how long any response lasted and the rate of complete responses — the data was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02002598 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total across five dose groups. The trial was testing a combination of three medicines — carfilzomib, bendamustine, and dexamethasone — in people with a blood cancer called multiple myeloma. The main goal was to find the highest dose of carfilzomib that could be given alongside the other two medicines without too many participants experiencing serious side effects (called "dose-limiting toxicities"). The trial tested five progressively higher dose combinations, with most participants (15 out of 20) enrolled at the highest dose level. The reported data shows that the highest dose level tested — carfilzomib at 56 mg/m², bendamustine at 90 mg/m², and dexamethasone at 20 mg — was identified as the maximum tolerated dose, meaning it met the trial's pre-set threshold for acceptable side effects. For the secondary outcomes, which looked at how participants responded to treatment over time, the reported data shows that 19 out of 20 participants showed either a complete or partial response (meaning their measurable disease markers reduced by the amounts defined in the trial). The reported data also shows that 17 out of 20 participants were still alive at the time results were recorded. The reported figures for how long it took participants to reach their best response, how long before they needed a new treatment, and how long before their disease progressed or they died were all reported as 77 months for both time-to-next-treatment and progression-free survival, and approximately 10 months for time to best response. It is worth noting that with only 20 participants across all groups, this was a very small trial designed primarily to test dosing rather than draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02654990 · results posted 12 July 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 248 people in total across three groups, all of whom were receiving a drug called panobinostat at different doses and schedules. Roughly 82–83 people started in each group. The trial was comparing these three dosing approaches to see how many participants showed a meaningful reduction in disease markers — a measurement called the "overall response rate" (ORR), which counted anyone whose disease showed at least a partial improvement based on standard assessment criteria. The reported data shows that, for the main outcome measured after up to eight treatment cycles, 62.2% of people in Group A (20 mg, three times a week), 65.1% in Group B (20 mg, twice a week), and 50.6% in Group C (10 mg, three times a week) met the threshold for a response. When responses were counted across the entire study period rather than just the first eight cycles, the figures were 62.2%, 67.5%, and 53.0% respectively. The reported data also shows how these responses broke down into deeper levels of improvement: the deepest category of response (called immunophenotypic complete response) was recorded in 3.7%, 1.2%, and 1.2% of participants across the three groups. Complete response rates were 8.5%, 8.4%, and 2.4%, while a "very good partial response" was seen in 19.5%, 25.3%, and 20.5% of participants in Groups A, B, and C respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03194867 · results posted 14 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03194867) enrolled 109 participants across four treatment groups. A small Phase 1 group of 3 people received a combination of two drugs — isatuximab and cemiplimab — given once every two weeks, to check for any early warning signs of serious side effects. The larger Phase 2 part then compared three approaches in 106 people: isatuximab alone (34 participants), isatuximab plus cemiplimab every two weeks (35–36 participants), or isatuximab plus cemiplimab every four weeks (36 participants). The trial was measuring how often participants' disease responded to treatment, as well as tracking side effects and how long any response lasted. The reported data shows that in Phase 1, none of the 3 participants experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious side effect severe enough to flag a problem with the dose. For side effects more broadly, the reported data shows that across all groups, most participants experienced at least one treatment-emergent adverse event (an unwanted medical occurrence after starting treatment): 3 of 3 in Phase 1, 33 of 34 in the isatuximab-alone group, 36 of 35–36 in the every-two-weeks combination group, and 33 of 36 in the every-four-weeks combination group. Serious adverse events were reported in 1 of 3 (Phase 1), 17 of 34, 17 of 35–36, and 21 of 36 participants respectively. The reported data shows that in Phase 2, the proportion of participants whose disease met the criteria for a measurable response was 11.8% in the isatuximab-alone group, 25.0% in the every-two-weeks combination group, and 22.2% in the every-four-weeks combination group. When a broader measure — including smaller, partial improvements — was used, those figures rose to 23.5%, 36.1%, and 38.9% respectively. Among participants who did show a response, the median length of time that response lasted was reported as 5.6 months, 4.7 months, and 5.7 months across the three groups. Participants were followed up for a median of approximately 8.8 to 10.3 months depending on the group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT03544281 · results posted 20 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03544281) tested a drug called belantamab mafodotin in combination with other medicines (either lenalidomide/dexamethasone or bortezomib/dexamethasone) in people with multiple myeloma, a type of blood cancer. The trial ran across two phases — a Main Study Phase and a PACT Phase — and enrolled a total of 165 participants across more than a dozen different dosing groups. The trial was primarily looking at whether certain serious side effects occurred early in treatment (called dose-limiting toxicities, or DLTs — meaning reactions severe enough to limit how much of the drug could be given), as well as tracking any unwanted medical events (adverse events) that participants experienced overall. The reported data shows that, for the groups specifically assessed for DLTs, zero out of the eligible participants in each tested combination experienced a dose-limiting toxicity during the defined early observation window. Regarding adverse events more broadly, the reported data shows that every single treated participant across all twelve main study groups — a total of 152 people — was recorded as having experienced at least one adverse event (an unwanted medical occurrence during the study). The trial also measured changes in a heart rhythm marker called QTcF (a way of checking whether the heart's electrical activity was affected), though the full numerical results for that measure were not completely available in the data provided to summarise here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05565391 · results posted 22 April 2024
According to the results reported on ClinicalTrials.gov, this study involved 508 people in total across three separate groups. The first group (123 people) came from a clinical trial called Study C1071003 Cohort A, where participants received a medicine called elranatamab. The other two groups — 233 people from a database called COTA and 152 people from a database called Flatiron Health — were real-world comparison groups drawn from existing patient records rather than a clinical trial. The study was measuring what proportion of participants showed a measurable reduction in their cancer (called an "objective response rate", or ORR), and how quickly that response appeared after starting treatment. The reported data shows that, in a straightforward comparison without any statistical adjustments, the ORR — meaning the percentage of people whose cancer showed a defined level of reduction — was 61.0% in the elranatamab clinical trial group, compared with 31.3% in the COTA real-world group and 30.3% in the Flatiron Health real-world group. The researchers also ran a more complex adjusted analysis (called IPTW, which is a statistical method to make the groups more comparable by accounting for differences in their characteristics). In that adjusted comparison, the reported ORR for the elranatamab group was 75.7% versus 34.2% for COTA, and 56.0% versus 31.3% for Flatiron Health. For the secondary measure — how long it took for a response to first appear (called "time to response") — the reported data shows that, across all analyses, responses were recorded at roughly 1.2 to 1.9 months from the start of treatment across all three groups, with no large differences between them in any of the comparisons. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05274763 · results posted 16 April 2024
According to the results reported on ClinicalTrials.gov, this trial looked at a spiritual care program called Compassion Centred Spiritual Health (CCSH), delivered by hospital chaplains to patients in a supportive care setting. Thirty people started the study and 29 completed it, with one person not finishing. The trial was primarily measuring how faithfully and consistently the program was delivered — not a health outcome as such, but rather whether the program could be rolled out as intended. It also tracked how many sessions patients completed, how much of the core program content they received, and how engaged they appeared to be during sessions. The reported data shows that on the main measure — a patient-reported questionnaire (scored from 5 to 25) asking how people felt about their chaplain visits — the average score recorded was 19.9, where higher numbers on that scale indicate a greater sense of improvement following the visit. For session attendance, the reported data shows 12 participants were counted in one category, 10 in another, and 8 in a third (described as low, moderate, and high adherence respectively), though the data as submitted does not clearly label which number belongs to which category. Similarly, for the amount of program content received and how responsive patients appeared during sessions, the reported figures show that across 54 recorded sessions, 33 were rated as participants being "maximally" enthusiastic and attentive, 17 "moderately," and 4 "minimally." Some of the more detailed breakdown figures for dosage categories were not fully labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02812706 · results posted 1 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02812706) tested a medicine called isatuximab in people with a type of blood cancer called multiple myeloma. The trial ran in two stages. In Phase 1, eight participants took part — three received a lower dose (10 mg/kg) and five received a higher dose (20 mg/kg) — to look at how the body tolerated the medicine at different dose levels. In Phase 2, a separate group of 28 participants all received the higher dose (20 mg/kg), and the main question being measured was how many participants showed an overall response, meaning some measurable reduction in signs of their cancer according to standard criteria. The reported data shows that in Phase 1, none of the participants in either dose group experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious side effect severe enough to restrict the dose — during the first treatment cycle. When it came to other medical events that occurred during treatment (called treatment-emergent adverse events), all three participants in the lower-dose group and four out of five in the higher-dose group experienced at least one such event. Serious treatment-emergent events were recorded in one participant in the lower-dose group and two in the higher-dose group. For the response to treatment in Phase 1, the reported data shows that approximately 67% of participants in the lower-dose group and 60% in the higher-dose group met the criteria for an overall response. The reported data also shows that among those who did respond, the time they maintained that response was around 101 weeks in the lower-dose group and approximately 114 weeks in the higher-dose group. In Phase 2, the reported data shows that 32.1% of the 28 participants met the criteria for an overall response to isatuximab at the 20 mg/kg dose. Regarding medical events during treatment in Phase 2, 25 out of 28 participants experienced at least one treatment-emergent adverse event, and 11 out of 28 experienced a serious treatment-emergent adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT06160609 · results posted 12 March 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT06160609) enrolled 9 people with multiple myeloma across two small groups: 6 participants received a lower dose combination (1.9 mg/kg of belantamab mafodotin plus 8 mg of a drug called OX40), and 3 participants received a higher dose combination (2.5 mg/kg of belantamab mafodotin plus the same OX40 dose). All 9 participants completed the study. The trial was in an early "dose exploration" phase, primarily looking at whether the drug combination caused serious dose-limiting side effects (that is, side effects severe enough to prevent continuing at that dose level), as well as tracking any adverse events (unwanted medical occurrences) and changes in blood test results. The reported data shows that no participants in either group experienced a dose-limiting toxicity. However, all 9 participants — all 6 in the lower-dose group and all 3 in the higher-dose group — experienced at least one adverse event of some kind. For blood test results, small numbers of participants showed worsening in some measures: for example, in the lower-dose group, changes were recorded in a small number of participants across various blood counts and chemistry markers, and similarly in the higher-dose group. The trial also measured how many participants' cancer responded to treatment (called the Overall Response Rate); the reported data shows a response rate of 0% in both groups during this dose-exploration phase. The reported data for the planned later "cohort expansion" phase of the trial — which was also supposed to report an Overall Response Rate — shows no measurements were submitted for that outcome, so those results were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT02441686 · results posted 4 March 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people who had been diagnosed with multiple myeloma. All participants received a combination of three medicines: lenalidomide, bortezomib (given as an injection under the skin), and dexamethasone. The trial was measuring how many participants showed a response to this treatment during the induction (initial treatment) phase, as well as tracking a particular side effect called peripheral neuropathy — a type of nerve-related symptom affecting the hands and feet. Of the 46 who started, 38 completed the induction phase, and 15 went on to receive a stem cell transplant. The reported data shows that, among those who could be assessed, 95% showed a response (defined as at least a partial response, meaning some reduction in measurable disease markers) after the first four treatment cycles, and 97.5% showed a response across the full induction period. Regarding peripheral neuropathy during the first four cycles, the reported data shows that 0.71 (or about 71%) of participants experienced this nerve-related side effect at any level of severity. Of those, a much smaller proportion — 0.07 (about 7%) — experienced it at the more severe levels (grade 3 or 4, meaning it significantly affected daily activities). For longer-term outcomes, the reported data shows that the estimated probability of being free from disease progression or death at one year was 89.2%. The median time to disease progression was not able to be calculated from the available data and was reported as not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01995708 · results posted 9 February 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT01995708) involved 28 people in total — 13 in the vaccine group and 15 in the control group. All 28 participants completed the study with no drop-outs recorded. The trial was looking at two things: first, monitoring participants for any side effects or unwanted reactions linked to a vaccine (tracked using a standard medical grading system); and second, measuring how long participants went without their condition getting worse (known as "progression-free survival"). The reported data shows that all 13 people in the vaccine group and all 15 people in the control group were monitored and assessed for reactions to the vaccine. For the second measure, the reported data shows that the middle value (median — meaning half the group did better and half did worse) for time without the condition worsening was 31 months in the vaccine group and 54 months in the control group. No further breakdown of side effect data was reported in the structured results submitted to ClinicalTrials.gov. It is important to note that this was a small study with fewer than 30 participants, which means the numbers should be interpreted with caution. No additional outcome data beyond what is described above was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03836053 · results posted 5 January 2024
According to the results reported on ClinicalTrials.gov, this trial tested three different daily doses of a drug called AMG 420 in people with a blood cancer called multiple myeloma. The three dose groups were 200 micrograms per day (1 person), 400 micrograms per day (12 people), and 600 micrograms per day (10 people) — 23 participants in total. The trial was primarily looking at how many people experienced serious side effects called "dose-limiting toxicities" (that is, side effects serious enough to limit how much of the drug could be given), as well as how many people experienced any side effects during treatment. A secondary aim was to measure how many participants showed a reduction in their cancer. The reported data shows that in terms of serious dose-limiting side effects, 1 person in the 200 µg group and 1 person in the 400 µg group experienced these, while none were reported in the 600 µg group. When looking at any side effects that appeared during treatment, all participants across all three groups experienced at least one — that is, 1 out of 1 in the lowest dose group, 12 out of 12 in the middle dose group, and 10 out of 10 in the highest dose group. For the secondary measure of overall response rate (meaning the percentage of participants whose cancer showed at least a partial reduction), the reported figures were 0% in the 200 µg group, approximately 42% in the 400 µg group, and 30% in the 600 µg group. The median length of time that a response lasted was reported as approximately 5.5 months in the 400 µg group; this figure was listed as not available for the other groups. A small number of participants — around 8% in the 400 µg group and 10% in the 600 µg group — showed what is called a "minimal residual disease negative" result at complete response, meaning very low or undetectable levels of cancer cells by a sensitive test. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04465760 · results posted 2 January 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 9 participants, all of whom completed the study with none dropping out. The trial was testing a drug called xisomab 3G3, and was measuring whether participants developed a blood clot in or around a central venous catheter (a tube inserted into a large vein, often used during cancer treatment). The study also tracked bleeding events and any unwanted side effects linked to the drug. The reported data shows that 1 out of the 9 participants developed a catheter-associated blood clot during the study. For the secondary measures, the data shows that 0 out of 9 participants experienced a major or clinically significant bleeding event, and 0 out of 9 participants had an adverse event (an unwanted health event) recorded as being associated with xisomab 3G3. The trial also recorded some blood-clotting-related measurements at a single point in time: a platelet count (tiny blood cells involved in clotting) of 275 cells·K/mm³, a PT/INR reading (a measure of how quickly blood clots) of 1.01, and an aPTT result (another clotting speed measure) of 50.76 seconds. No comparison or context figures were reported for these measurements, so it is not possible to say what they mean relative to a control group. It is worth noting that this was a very small study of only 9 people, and the results as submitted do not include a comparison group, which limits what can be drawn from the numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02375555 · results posted 6 December 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people who received a combination of four medicines: elotuzumab, lenalidomide, bortezomib, and dexamethasone. The trial was measuring how well participants' blood cancer (multiple myeloma) responded to this combination treatment over several stages — an induction phase (up to 8 treatment cycles), a possible stem cell transplant, and a maintenance phase. Of the 40 who started, 29 completed the induction period and moved into the maintenance period, though none had completed the maintenance period by the time results were recorded. The reported data shows that the main thing being measured — how many participants showed at least a partial response to treatment after the first four cycles — was reported as approximately 97 in every 100 participants (a proportion of 0.971). Looking at the best responses recorded across all 40 participants, the reported data shows: 9 achieved a stringent complete response (the deepest level of response measured), 8 a complete response, 16 a very good partial response, 5 a partial response, and 1 had a different outcome. By the end of up to 8 cycles of treatment, around 95 in every 100 participants (0.950) had shown at least a partial response. For those who needed to collect stem cells, approximately 97 in every 100 (0.968) were reported to have successfully collected enough cells. The reported data also shows that around 40 in every 100 participants (0.40) needed their dose of at least one medicine adjusted during the first four cycles. Separately, approximately 70 in every 100 participants (0.70) experienced a grade 3 or 4 adverse event — meaning a more serious unwanted health event recorded during treatment — though the data does not break these events down further in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02004275 · results posted 1 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02004275) studied treatments for multiple myeloma (a type of blood cancer) across two phases. In the first phase, 26 people took part across four different dose levels, to find the highest dose of the drugs pomalidomide and ixazomib that could be given together without causing serious side effects. In the second phase, 92 people were randomly assigned to one of two groups: 45 received pomalidomide plus dexamethasone, and 47 received pomalidomide plus dexamethasone plus ixazomib. The main things being measured in Phase 2 were how long people went without their disease getting worse, as well as how many people showed a response to treatment. The reported data shows that in Phase 1, out of all four dose levels tested, only one participant at dose level 3 and one participant at dose level 4 experienced what the trial defined as a serious enough side effect to count as a "dose-limiting toxicity" (a side effect severe enough to potentially prevent a higher dose being used). Regarding dose reductions or delays — where a participant's dose had to be lowered or their treatment paused — the reported numbers were 2 people at dose level 1, 3 at dose level 2, 6 at dose level 3, and 5 at dose level 4. For the Phase 2 results, the reported data shows that the time without disease worsening (called progression-free survival) was reported as 228 days on average for the two-drug group and 619 days for the three-drug group. The proportion of participants who showed a measurable response to treatment was reported as approximately 43.6% in the two-drug group and 63.2% in the three-drug group. A broader measure — including those with even a small degree of response — was reported as approximately 56.4% for the two-drug group and 73.7% for the three-drug group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04843579 · results posted 25 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04843579) tested a combination of four medicines — selinexor, clarithromycin, pomalidomide, and dexamethasone (together called "ClaSPd") — in people with a blood cancer called multiple myeloma. The trial enrolled 4 participants in total. Of those 4, 2 completed the study and 2 did not finish. The trial was measuring how many participants showed a meaningful reduction in signs of their disease (called an "overall response"), as well as tracking any unwanted health events (called adverse events) that occurred during the study. The reported data shows that 2 out of the 4 participants met the threshold for an "overall response" — meaning their test results showed at least a partial improvement according to standard myeloma criteria. Regarding unwanted health events, the reported data shows that all 4 participants experienced at least one adverse event during the study period. No further breakdown of the types or severity of those events was included in the structured results submitted to ClinicalTrials.gov. It is worth noting that only 4 people took part in this trial, which is a very small number, and the results should be understood in that context. The reported data shows only what was observed in this small group and does not allow for broader conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04649359 · results posted 25 October 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 187 people across two groups: 123 participants in Cohort A and 64 participants in Cohort B. The trial was studying a treatment for multiple myeloma (a type of blood cancer) in people who had already tried several other treatments. The main thing the trial was measuring was the **objective response rate (ORR)** — that is, the percentage of participants whose disease showed a meaningful reduction according to standard criteria, as assessed by an independent review team who did not know which treatment participants had received. The reported data shows that in Cohort A, 61.0% of participants met the criteria for a response. In Cohort B, the reported figure was 34.4%. Among Cohort A participants who had disease that had spread outside the bone marrow at the start of the trial, the reported response rate was 38.5%, while for those in Cohort A who did not have that spread at the start, the reported figure was 71.4%. For several other planned measurements — including how long responses lasted (in both Cohort A and B) and the rate of complete responses — no numerical data was reported in the submitted results. It is also worth noting that the data shows zero participants were recorded as having "completed" the study in either group, which may reflect how completion was defined for this particular trial; however, no further explanation for this was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04162210 · results posted 6 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04162210) enrolled 218 people in the belantamab mafodotin group and 107 people in the pomalidomide plus dexamethasone (a standard combination treatment) group. The trial was looking at how these two treatments compared across several measures in people with a type of blood cancer called multiple myeloma, including how long people lived, how many showed a response to treatment, and how long any response lasted. The reported data shows the following numbers. For overall survival — meaning how long people lived from the time they joined the trial — the belantamab mafodotin group had a reported median (the midpoint value, where half were above and half below) of 24.0 months, compared with 22.9 months in the pomalidomide plus dexamethasone group. For overall response rate — the percentage of participants whose disease showed a meaningful reduction — 41% in the belantamab mafodotin group and 36% in the pomalidomide plus dexamethasone group met this measure. The clinical benefit rate, which includes a slightly broader definition of any meaningful reduction in disease markers, was reported as 47% in both groups. For duration of response — how long that response lasted — the reported median was 25.3 months for belantamab mafodotin and 9.9 months for pomalidomide plus dexamethasone. The time until a response was first recorded was a median of 2.10 months versus 1.53 months, and the time until the disease progressed was a median of 11.3 months versus 8.6 months, for belantamab mafodotin and pomalidomide plus dexamethasone respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02755597 · results posted 22 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02755597) enrolled 291 adults with multiple myeloma — 194 in one group and 97 in another. One group received venetoclax combined with two other medicines (bortezomib and dexamethasone), while the other group received a placebo (an inactive substitute) combined with the same two medicines. The trial's main goal was to measure **progression-free survival** — that is, how long participants went without their disease getting worse or without dying. The reported data shows that, on average, participants in the venetoclax group went 23.2 months before their disease progressed or they died, compared with 11.5 months in the placebo group. Among participants whose tumour cells showed high levels of a particular protein called BCL-2, the reported figures were 23.8 months versus 11.4 months respectively. For the secondary outcomes, the reported data shows that 60.3% of participants in the venetoclax group achieved a "very good partial response or better" (meaning their cancer showed a substantial reduction by set criteria), compared with 38.1% in the placebo group. The duration of response — how long that response lasted — was reported as 12.8 months for the placebo group; the figure for the venetoclax group was not reported (listed as "not available" in the data). Small changes in self-reported pain scores and physical functioning were also measured across both groups at several time points, with modest differences between the two groups; the full breakdown across all time points is included in the ClinicalTrials.gov record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04439357 · results posted 4 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04439357) looked at a drug called trametinib in people with certain cancers. Four participants were enrolled and began treatment. None of the four participants completed the study — all four did not finish, though the data does not provide a breakdown of the reasons why. The reported data shows that the main thing the trial was measuring was the "objective response rate" — that is, the proportion of participants whose cancer showed a meaningful shrinkage or disappearance during treatment, based on standardised imaging criteria. The reported figure for this was 25%, meaning one out of the four participants met that response threshold. For the secondary measures, the reported data shows that 50% of participants had not experienced their cancer progressing or died within six months of starting treatment. The middle point of "progression-free survival" — the length of time from starting treatment until the cancer got worse or a participant died, whichever came first — was reported as 6.5 months. Because only four people took part, these numbers are based on a very small group and should be interpreted with that in mind. It is also worth noting that the trial was very small — far fewer participants than trials typically need to draw broad conclusions — and this limits what can be read into any of these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01734928 · results posted 6 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT01734928) enrolled 559 people with multiple myeloma — 281 in one group and 278 in the other. Participants were randomly assigned to receive either a three-drug combination (pomalidomide, bortezomib, and low-dose dexamethasone, referred to here as POM+BTZ+LD-DEX) or a two-drug combination (bortezomib and low-dose dexamethasone, BTZ+LD-DEX). The main thing the trial was measuring was how long participants went without their disease getting worse — known as "progression-free survival." The reported data shows that, on average, participants in the three-drug group went approximately 11.2 months before their disease progressed or they died, compared to approximately 7.1 months in the two-drug group. For overall survival — meaning time from the start of the trial until death from any cause — the reported figures were around 35.6 months for the three-drug group and 31.6 months for the two-drug group. Looking at how many people showed a measurable response to treatment, the reported data shows that 231 out of 278 participants in the three-drug group had some level of response (ranging from partial to complete), compared to 139 out of 270 in the two-drug group. Among those who did respond, the response lasted a reported average of approximately 13.7 months in the three-drug group and 10.9 months in the two-drug group. Regarding adverse events (unwanted side effects) rated as serious, the reported data shows 259 participants in the three-drug group and 194 in the two-drug group experienced Grade 3–4 events, while 29 and 12 participants respectively experienced Grade 5 events (meaning fatal adverse events). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02416206 · results posted 18 May 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people, all of whom completed the study (none dropped out). All participants received the same treatment regimen, called BeEAM, which is a combination of chemotherapy drugs given before a stem cell transplant. The trial was primarily looking at how many participants achieved a "complete response" — meaning no detectable signs of the disease — by day 100 after the transplant, using standard international criteria to measure this. The reported data shows that, at day 100 after the transplant, 26 participants were recorded as achieving a complete response (CR), 32 participants reached a "very good partial response" (meaning the disease was still just barely detectable but greatly reduced), and 7 participants had a partial response (meaning a significant but smaller reduction in disease markers). For the secondary measures, the reported data shows that 60 out of 65 participants were recorded as alive at the time overall survival was assessed, 37 participants were recorded as alive without their disease progressing, and 28 participants were recorded as having experienced a relapse (the disease returning) after the transplant. The time points at which these survival and relapse figures were measured were not specified in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03465540 · results posted 12 April 2023
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called AMG 397 in people with certain blood cancers — specifically multiple myeloma, non-Hodgkin's lymphoma, and acute myeloid leukaemia. A total of 24 participants took part across two parts of the study (Part 1a and Part 1b), split into groups receiving one of three doses: 80 mg, 160 mg, or 320 mg. The trial was primarily measuring how many participants experienced serious unwanted effects — called "dose-limiting toxicities" (serious side effects within the first 28 days thought to be related to the drug) and "treatment-emergent adverse events" (any unwanted health event that occurred after the first dose). A smaller number of participants completed the full study across all groups. The reported data shows that, when it came to dose-limiting toxicities, one participant in the Part 1a 320 mg group and one participant in the Part 1b 320 mg group experienced such an event — all other groups reported zero. For treatment-emergent adverse events, the reported data shows these occurred across all groups, with every participant in each group recorded as having experienced at least one such event. Regarding the secondary outcomes — which looked at how participants' cancers responded to treatment — the reported data shows that 0% of multiple myeloma participants and 0% of acute myeloid leukaemia participants met the criteria for a response at any dose. Among non-Hodgkin's lymphoma participants, 100% of those in the Part 1a 80 mg group met the response criteria, while 0% in the 160 mg group did; however, it is important to note these groups were very small. The progression-free survival data (the length of time before the disease worsened or a participant died) was not reported for any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01899326 · results posted 28 March 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people, all of whom had multiple myeloma (a type of blood cancer). Participants received a combination of two medicines — filgrastim and desipramine — with the aim of stimulating the body to release stem cells into the bloodstream so they could be collected for a transplant. This process is called stem cell mobilisation. Of the 10 people who started the trial, 6 completed it and 4 did not finish. The reported data shows that for the first primary goal — measuring how many participants who were new to mobilisation (or had not previously been treated with a particular class of chemotherapy called alkylating agents) reached the target stem cell collection amount — 6 participants achieved that target. For the second primary goal, which looked at participants who had previously failed mobilisation, had been exposed to alkylating therapy, or were expected to be harder to mobilise, no results data was reported on ClinicalTrials.gov. Regarding the secondary measurements, the reported data shows that the middle value (median) number of days needed for the collection procedure (apheresis) was 1.5 days. A total of 9 adverse events (unwanted health occurrences noted during or shortly after treatment) were recorded. For those who went on to receive a transplant, the median time for white blood cells to recover was reported as 12 days, and the median time for platelets (cells that help blood clot) to recover was reported as 13.5 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02919670 · results posted 16 March 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02919670) enrolled 99 people in total — 49 who received a drink called Enterade alongside standard supportive care, and 50 who received a placebo (an inactive substitute) alongside standard supportive care. The trial was measuring whether there were differences between the two groups in severe bowel-related side effects, specifically diarrhoea graded at level 3 or higher (meaning serious enough to significantly affect daily life or require medical intervention), as well as a range of other measures such as stool frequency, hospital stay length, weight changes, and use of anti-diarrhoea medications. The reported data shows that among those who received Enterade, 18 out of 49 participants experienced grade 3 or higher diarrhoea, compared with 21 out of 50 in the placebo group. For the highest number of bowel movements recorded in a single day, the reported figures were 5–6 per day in the Enterade group and 5–6 per day in the placebo group. The reported data shows the average hospital stay was 17 days in both groups. Weight change from the start to day 14 was reported as a decrease of 2.5% in the Enterade group and 2.2% in the placebo group. The median amount of anti-diarrhoea medication used was reported as 27 mg in the Enterade group and 30 mg in the placebo group. It is also worth noting that a large number of participants in both groups did not complete the study — 43 in the Enterade group and 39 in the placebo group — though the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03639610 · results posted 9 March 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03639610) enrolled 35 participants in total across three groups, each receiving a different dose of a drug called melflufen: 21 people received 40 mg (Cohort 1a), 10 received 30 mg (Cohort 1b), and 4 received 20 mg (Cohort 2a). The trial was primarily measuring how the drug moved through the body — specifically how quickly it reached its peak level in the blood, how high that peak was, and how long it took to clear from the body. None of the participants were recorded as having formally "completed" the study, though the data was still reported. The reported data shows that in the 40 mg group, the drug reached its highest concentration in the blood at around 38 minutes, with a peak level of approximately 550 ng/mL (nanograms per millilitre, a measure of how much of the drug was in the blood). In the 30 mg group, the peak was around 472 ng/mL at about 40 minutes, and in the 20 mg group, the peak was approximately 181 ng/mL at around 37 minutes. The time it took for the drug's level to fall by half (called the "half-life") was roughly 89 minutes in the 40 mg group, 98 minutes in the 30 mg group, and 110 minutes in the 20 mg group. As a secondary measure, the trial also tracked how participants' disease responded. The reported data shows that in the 40 mg group, 7 participants had a partial response and 3 had a very good partial response; in the 30 mg group, 4 had a partial response, 1 had a very good partial response, and 2 had a complete response; in the 20 mg group, 1 participant had a partial response. No complete responses were recorded in the 40 mg or 20 mg groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03439280 · results posted 24 February 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03439280) tested a drug called mezagitamab in people with a blood cancer called multiple myeloma. The trial had two main stages: a Phase 1 part, where different doses of mezagitamab were tested — 45 mg, 135 mg, 300 mg, 600 mg, and 1200 mg — either alone or combined with two other medicines (pomalidomide and dexamethasone, known together as "PomDex"); and a Phase 2a part. A total of 50 people were enrolled across all groups in Phase 1, while the Phase 2a group reported zero participants started. The trial's primary focus in Phase 1 was tracking medical events (called "adverse events") that occurred after participants received the study drug. The reported data shows that across all Phase 1 groups, every participant experienced at least one treatment-emergent adverse event (that is, any unwanted medical occurrence after the first dose). Regarding more serious events, the number of participants who experienced severe or life-threatening adverse events (Grade 3 or higher) ranged from 1 out of 3 participants in the 135 mg group to 12 out of 22 in the 600 mg group, and all 6 participants in the combination PomDex group. Serious adverse events — those resulting in hospitalisation or other significant outcomes — were reported in 0 participants in the two lowest-dose groups, rising to 8 out of 22 in the 600 mg group and 2 out of 6 in the combination group. Only 1 participant across all groups met the definition of a "dose-limiting toxicity" (a predefined level of reaction used to judge whether a dose is too high), and that occurred in the combination group. Adverse events led to treatment being stopped entirely in 2 participants in the 600 mg group and 3 in the combination group, with zero discontinuations in the other groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03275285 · results posted 13 February 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03275285) enrolled 302 people with multiple myeloma — 123 in a group receiving two medicines (carfilzomib and dexamethasone, called "Kd") and 179 in a group receiving three medicines (isatuximab added to the same two, called "IKd"). The trial was measuring how participants' disease responded to treatment, including how many showed a measurable reduction in myeloma, how deeply that reduction went, and whether traces of myeloma cells became undetectable at a molecular level (called "minimal residual disease negativity," or MRD negativity — meaning no detectable cancer cells could be found using a very sensitive test). The reported data shows that, when an independent committee reviewed responses, about 82.9% of the Kd group and 86.6% of the IKd group showed some level of measurable response to treatment. Looking at deeper responses — defined as a very good partial response or better (meaning at least a 90% reduction in certain myeloma markers) — the reported figures were 56.1% for Kd and 72.6% for IKd. For the deepest category, a complete response or better, the final analysis reported 28.5% for Kd and 44.1% for IKd. The reported data also shows figures for MRD negativity among those who achieved at least a very good partial response: in the primary analysis, 13.0% of the Kd group and 29.6% of the IKd group reached this level; in the final analysis, those figures were 13.8% and 33.5% respectively. For MRD negativity among those who reached a complete response or better, the final analysis reported 12.2% for Kd and 26.3% for IKd. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01951885 · results posted 31 January 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 101 people who were undergoing a stem cell transplant from a donor. Participants were split into two groups: 50 people received a combination of two medicines (tacrolimus and methotrexate) to help prevent a complication called graft-versus-host disease (GVHD) — a condition where the donor's immune cells attack the recipient's body — while 51 people received those same two medicines plus a third (mycophenolate mofetil). The trial tracked several things, including mouth sores (mucositis), how quickly the transplanted cells began working in the body (called "engraftment"), and rates of GVHD. The reported data shows that 81.6% of people in the two-medicine group developed severe mouth sores, compared with 57.4% in the three-medicine group. For engraftment, the two-medicine group's white blood cells (neutrophils) took a reported median of 17 days to recover, versus 15 days in the three-medicine group; platelets took a reported median of 27 days versus 23 days respectively. Regarding GVHD, the reported data shows that in the two-medicine group, 37% developed any grade of acute GVHD, 27% developed moderate-to-severe GVHD (grade 2–3), and 4% developed the most severe form (grade 4); in the three-medicine group those figures were 47%, 28%, and 13% respectively. For secondary outcomes, the reported average hospital stay was 31 days in the two-medicine group and 27 days in the three-medicine group, and roughly 41% versus 38% of participants required intravenous nutrition (feeding directly into the bloodstream) within 100 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02609828 · results posted 20 January 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02609828) enrolled 156 people across four groups: 74 received a placebo (a dummy treatment with no active ingredient), 72 received tanezumab 20 mg, 9 received tanezumab 10 mg, and 1 received tanezumab 10/20 mg. All participants had cancer that had spread to the bones, causing pain. The trial's main focus was measuring changes in self-reported pain scores over time using an 11-point scale (0 = no pain, 10 = worst possible pain). It is worth noting that the two smaller groups — tanezumab 10 mg and tanezumab 10/20 mg — had very few participants, and the reported data shows most numerical results were only available for the placebo and tanezumab 20 mg groups. The reported data shows that for the primary outcome — change in average daily pain score at the main painful bone site after 8 weeks — the placebo group's scores decreased by 1.25 points on average, while the tanezumab 20 mg group's scores decreased by 2.03 points on average (both measured from their starting scores before treatment). For the secondary outcomes measured at earlier time points, both groups also showed reductions in pain scores over weeks 1, 2, and 4, with the tanezumab 20 mg group consistently showing larger reported decreases. Similar patterns were reported for "worst pain" scores and pain at other cancer-affected sites. No numerical data was reported for the change in pain at non-bone (visceral) cancer sites. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02633059 · results posted 2 December 2022
According to the results reported on ClinicalTrials.gov, this two-phase trial tested a combination of three medicines — ixazomib citrate, idasanutlin, and dexamethasone — in people with a type of blood cancer called multiple myeloma. A total of 33 people took part across all groups. The first phase (Phase 1, 15 participants across three dose levels) was focused on finding the highest dose of the medicine combination that could be given without causing too many serious side effects — this is called the "maximum tolerated dose." The second phase (Phase 2, 18 participants) then tested that dose level further, looking at how many participants' cancer responded to the treatment. The reported data shows that in Phase 1, no participants at the two lower dose levels experienced what researchers called a "dose-limiting toxicity" (a serious side effect serious enough to cap the dose), while 2 out of 4 participants at the highest dose level did. This led to the middle dose level being carried forward into Phase 2. For the main Phase 2 question — how many participants showed a confirmed response (meaning their cancer shrank or disappeared on two separate check-ups) — the reported data shows 2 participants had a complete response, 6 had a very good partial response, and 14 had a partial response, out of the combined Phase 1 and 2 group assessed together. The reported data also shows that the median time participants lived without their cancer getting worse (progression-free survival) was 3.8 months, and the median overall survival was 21.0 months. Regarding side effects tracked across both phases, the reported data shows that varying numbers of participants across all groups experienced adverse events of different severity levels, though the full breakdown of what those events were is not detailed in the structured data provided here. It is worth noting that a small number of participants did not complete the study — 1 in Phase 1 and 2 in Phase 2 — though the reasons were not reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02843074 · results posted 17 October 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02843074) enrolled 52 people, all of whom received a combination treatment referred to as "ERd therapy" — a regimen involving three medicines: elotuzumab, lenalidomide, and dexamethasone. The trial was primarily looking at whether patients could complete four months of this treatment and then go on to have a stem cell transplant using their own stem cells. Of the 52 who started, 35 completed the study and 17 did not. The reported data shows that 33 out of 52 participants successfully completed the induction (lead-in) treatment phase and proceeded to a stem cell transplant — this was the main thing the trial was set up to measure. For the secondary measurements, 47 out of 52 participants were reported as showing some level of measurable response (what the trial called an "overall response," meaning at least a partial reduction in markers of their condition). A smaller number — 25 out of 52 — were reported as achieving a complete or near-complete response (meaning markers of the condition became very low or undetectable by certain tests). The reported data also shows a "progression-free survival" figure — roughly, the length of time before the condition showed signs of worsening — of approximately 29.7 months. The overall survival figure was recorded as "not available" in the submitted data, so that result was not reported. All 52 participants were included in the adverse events (unwanted health events that occurred during treatment) count, though the specific nature of those events is not detailed in the submitted summary data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01463670 · results posted 6 May 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 11 participants, all of whom completed the study — none dropped out. Every participant received the study treatment, lenalidomide. The trial was measuring how many participants responded to the treatment, meaning whether tumours shrank or disappeared based on a standard set of imaging criteria (called RECIST), as well as tracking unwanted side effects of a certain severity or higher. The reported data shows that, of the 11 participants, 1 had a complete response (meaning all target areas of disease appeared to disappear on scans), 1 had a partial response (meaning the target areas shrank by 30% or more), and 7 had stable disease (meaning the disease neither shrank enough to count as a response nor grew enough to count as progression). The remaining 1 participant had progressive disease (meaning the disease grew). This gives an overall response — counting complete and partial responses together — of 2 out of 11 participants. The reported data also shows that all 11 participants were evaluated for side effects rated at a moderate level or above, though the specific types or numbers of those side effects were not broken down further in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01496118 · results posted 2 February 2022
According to the results reported on ClinicalTrials.gov, a total of 80 people took part in this trial across eight groups, each receiving different dose levels of the study drug combination. The trial was looking at two things: first, finding the right dose by checking how many participants at each level experienced serious unwanted side effects (called "dose-limiting toxicities") during the early phase; and second, in the later phase, measuring how many participants showed a meaningful reduction in their cancer (known as the "overall response rate") at the two dose levels chosen for further study. The reported data shows that in the early dose-finding phase (Dose Levels 1 through 6, with 3–4 people per group), zero participants at any of the six dose levels experienced a dose-limiting toxicity. For the later phase, the trial focused on two dose levels. At Dose Level 4 (combining the escalation and expansion groups), 74% of participants were reported to have had a confirmed meaningful reduction in their cancer. At Dose Level 6, the reported figure was 84%. The reported data also shows results for several other measurements tracked over time. "Time to progression" — meaning how long before the disease started worsening again — was reported as 11.6 months for the Dose Level 4 group and 11.7 months for Dose Level 6. "Progression-free survival" — the time before the disease worsened or a participant died — was reported as 12.1 months and 10.3 months respectively. "Overall survival" — the time from the start of treatment until death or last known to be alive — was reported as 29.2 months for Dose Level 4 and 44.6 months for Dose Level 6. No participants were recorded as having completed the study, which the data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04097301 · results posted 19 January 2022
According to the results reported on ClinicalTrials.gov, this was a Phase I clinical trial testing an experimental CAR T-cell treatment called MLM-CAR44.1 — a type of therapy where a patient's own immune cells are modified in a laboratory to try to target cancer cells. The trial enrolled people with certain blood cancers (acute myeloid leukaemia or multiple myeloma). A total of 8 people were enrolled in the study, but only 2 of those went on to actually receive the treatment. One participant completed the study, while 7 did not complete it. The reported data shows that among the two participants who received the treatment, 3 serious adverse events (that is, significant medical problems considered serious enough to report formally) were recorded in total. The trial also monitored for a specific safety concern called replication competent retrovirus (RCR) — essentially checking whether the virus-based method used to modify the immune cells had accidentally created any virus capable of multiplying in the body, which would be an unwanted risk. The reported data shows that 2 participants were tested for this at both the 3-month and 6-month follow-up points. Results for the 12-month and 24-month RCR checks were not reported in the data. The reported data also shows that no numbers were provided for one of the primary goals of the trial — establishing the maximum tolerated dose of the treatment — which may reflect the very small number of participants who were actually treated. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01712789 · results posted 10 January 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 682 people who were being treated with a combination of two medicines — pomalidomide and low-dose dexamethasone. Of those, 676 actually received the study treatment. The trial did not have a comparison group; everyone received the same treatment. The main thing the trial was set up to measure was the number of participants who experienced unwanted medical events (called "treatment emergent adverse events") while on the treatment. A smaller category of these — called "serious adverse events" — covered things like events that resulted in death, were life-threatening, or required a hospital stay. The reported data shows that out of 676 people who received the treatment, 673 experienced at least one unwanted medical event of any kind, and 527 experienced what were classified as serious adverse events. The remaining numbers reported under this measure (448, 575, 606, 417, 226, 448, 127, 14, 16, and 18 participants) appear to relate to different sub-categories of those events, though the specific breakdown labels for each figure were not fully detailed in the submitted data. For the secondary measures, the reported data shows that 33.4% of participants had a measurable reduction in their disease (classed as an "overall response"). Among those who did respond, the reported data shows it took a median of around 8.1 weeks for that response to first appear, and the response lasted a median of about 7.9 months. The reported median time before the disease started progressing again was 4.6 to 4.8 months, depending on the method used to calculate it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03170882 · results posted 27 October 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03170882) involved 122 people with a blood cancer called multiple myeloma — 49 were assigned to receive pomalidomide plus dexamethasone, and 73 were assigned to receive ixazomib plus dexamethasone. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), and also tracked a number of other things including how long participants lived overall, how many showed a measurable response to treatment, how long any response lasted, and how quickly a response appeared. The reported data shows that, for the main measure — time until the disease progressed or the participant died — the pomalidomide plus dexamethasone group had a median of 4.8 months, while the ixazomib plus dexamethasone group had a median of 7.1 months. (Median means half the participants in each group reached that point before that time, and half after.) For overall survival — time from the start of the trial until death from any cause — the reported figure for the pomalidomide group was listed as "not available" in the submitted data, while the ixazomib group had a median of 18.8 months. Regarding measurable response to treatment, 41% of participants in the pomalidomide group and 38% in the ixazomib group were reported to have shown a response. Among those who did respond, the duration of that response was reported as 14.3 months for the pomalidomide group and 14.8 months for the ixazomib group. The time until a response first appeared was reported as 1.1 months for the pomalidomide group and 2.0 months for the ixazomib group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02561962 · results posted 7 October 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02561962) tested a drug called AMG 224 in people with a blood cancer called multiple myeloma. A total of 42 people took part, spread across nine groups that received different doses of AMG 224. The trial was set up in two stages: a dose-exploration stage (where seven different dose levels, labelled A through G, were tested in small groups of 3–6 people) and a dose-expansion stage (where a chosen dose, labelled Dose H, was given to two further groups — one that had previously received a certain type of antibody treatment targeting a protein called CD38, and one that had not). The trial was primarily measuring how many participants experienced serious, predefined side effects known as "dose-limiting toxicities" (DLTs) — that is, side effects severe enough to limit how much of the drug could be given. It also tracked how many participants experienced any medical event after starting treatment. The reported data shows that, for the primary outcomes, DLTs were recorded in 0 out of 3 participants at Doses A, B, C, and D; 0 out of 6 at Dose E; 1 out of 6 at Dose F; and 3 out of 5 at Dose G. No DLTs were reported in either of the Dose H expansion groups. For the second primary outcome — the number of people who experienced any medical event after receiving at least one dose — all participants who received treatment appeared to have at least one such event recorded across all groups (3, 3, 3, 3, 6, 6, 5, 9, and 2 participants respectively in each group). The reported data also includes several secondary measurements tracking how the drug moved through the body over time (sometimes called pharmacokinetics). These figures — such as peak blood levels, lowest blood levels between doses, and the total drug exposure over time — generally appeared to increase as the dose increased across the exploration groups, with the highest dose exploration groups and the expansion group showing broadly similar figures to one another. The clearance rate (how quickly the body removed the drug) was also measured across groups. These figures were reported for the drug in several different forms as it was processed by the body, but individual numbers for all sub-components across all groups were not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00445068 · results posted 14 July 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 38 people who had been diagnosed with multiple myeloma (a type of blood cancer) and had already tried at least two previous treatments, with their disease no longer responding to the most recent one. All 38 participants received the study drug, panobinostat. The trial was primarily measuring how many participants had their cancer shrink or disappear (known as a "response rate"), and a number of secondary measures were also tracked, including how long any response lasted, how quickly a response appeared, and how long participants lived without their disease getting worse. The reported data shows that only 2 of the 38 participants completed the study, while 36 did not complete it. Unfortunately, no numerical results were reported on ClinicalTrials.gov for any of the outcome measures — this includes the primary measure (response rate) and all secondary measures such as overall response rate, clinical benefit rate, duration of response, time to response, and progression-free survival. Because this data was not provided in the submitted results, it is not possible to describe what the measurements showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03110562 · results posted 8 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03110562) enrolled 402 people with multiple myeloma — 195 in a group receiving selinexor combined with bortezomib and dexamethasone (called the SVd group), and 207 in a group receiving bortezomib and dexamethasone alone (called the Vd group). An additional 80 participants later entered a crossover phase and received modified drug combinations. The trial was primarily measuring how long people went without their disease getting worse (called "progression-free survival"), and also looked at a range of other outcomes including overall response rates, how long responses lasted, overall survival, and the number of people who experienced a particular nerve-related side effect called peripheral neuropathy. The reported data shows that, for the main outcome, the SVd group went a reported median (middle value) of about 13.9 months before their disease progressed or they died, compared with about 9.5 months in the Vd group. For overall response — meaning the proportion of people whose disease showed at least a partial improvement — the reported figures were 76.4% in the SVd group and 62.3% in the Vd group. When looking only at deeper responses (called "very good partial response or better"), the reported figures were 44.6% in the SVd group and 32.4% in the Vd group. The reported data shows that the median time people maintained a response was about 17.3 months in the SVd group and about 12.9 months in the Vd group. For overall survival, the reported median was approximately 36.7 months in the SVd group and 32.8 months in the Vd group. Regarding peripheral neuropathy (nerve-related events graded as moderate or worse), the reported data shows 41 participants in the SVd group and 70 participants in the Vd group experienced at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01999335 · results posted 27 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT01999335) enrolled a total of 33 participants across five treatment groups. Each group received a different combination of doses of three medicines: oprozomib (taken by mouth), pomalidomide, and dexamethasone. The trial was primarily measuring safety-related outcomes — specifically, how many participants experienced serious side effects severe enough to limit the dose (called "dose-limiting toxicities"), how many experienced adverse events (unwanted medical events) during treatment, and how many had severe abnormal blood or chemistry test results. A secondary goal was to look at how many participants' disease responded to treatment, and how the body absorbed oprozomib. The reported data shows that when it came to dose-limiting toxicities, 2 out of 3 participants in the lowest oprozomib dose group (150 mg, 5/14 schedule with pomalidomide 4 mg) and 1 out of 7 in the 210 mg group experienced these events; no dose-limiting toxicities were reported in the other groups. For unwanted medical events that appeared during treatment, all participants across every group experienced at least one such event. Severe laboratory abnormalities (grade 3 or 4, meaning notably outside the normal range) were reported in 2 of 3 participants in one group, rising to 8 of 10 participants in two of the higher-dose groups. Regarding disease response, the reported data shows that the proportion of participants whose disease showed a measurable response ranged from 33.3% in one group up to 100% in another (the smallest group, with only one participant). The reported data for oprozomib blood concentration levels varied across dose groups, with higher doses generally associated with higher recorded levels in the bloodstream. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02036502 · results posted 8 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02036502) tested different combinations and doses of three medicines — pembrolizumab (an immunotherapy), lenalidomide, and dexamethasone (or in one group, carfilzomib instead of lenalidomide) — in people with multiple myeloma (a type of blood cancer). The trial was run in three parts: Part 1 found the right doses to use, Part 2 confirmed those doses, and Part 3 expanded to a larger group. In total, 77 people were enrolled across all parts and groups, with the largest group (47 people) receiving pembrolizumab 200 mg plus lenalidomide 25 mg plus dexamethasone 40 mg in Part 3. The reported data shows that one of the main things measured was whether participants experienced "dose-limiting toxicities" (DLTs) — that is, side effects serious enough during the first treatment cycle to suggest the dose may be too high. In the highest-dose group in Part 1 (pembrolizumab 2 mg/kg plus lenalidomide 25 mg plus dexamethasone 40 mg), 3 out of 6 participants were reported to have experienced a DLT; no DLTs were reported in the other dose groups assessed for this measure. The reported data also shows that adverse events (any unwanted medical occurrences during the study, whether or not related to the treatment) were recorded for all participants who received treatment — for example, all 45 treated participants in the largest Part 3 group experienced at least one adverse event, and 4 of those 45 stopped treatment due to an adverse event. In the Part 3 carfilzomib group, 6 out of 10 participants stopped treatment due to an adverse event. Regarding secondary outcomes, the reported data shows that for the pooled group of participants with relapsed and refractory multiple myeloma (cancer that had come back and stopped responding to prior treatment), 30.2% were reported to have achieved at least a partial response to treatment — meaning their measurable markers of disease reduced by a defined amount. For the pooled group with relapsed multiple myeloma (cancer that had come back but was not necessarily treatment-resistant), this figure was reported as 70.0%. The disease control rate — meaning the percentage of participants whose disease either responded or remained stable for at least 12 weeks — was reported as 84.1% in the relapsed/refractory group and 100% in the relapsed group. Numbers for individual smaller groups and some other outcome measures were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00525057 · results posted 22 January 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total, split into two groups of 25. One group had metastatic bone disease (cancer that had spread to the bones) and the other had sarcoma (a type of bone or soft-tissue cancer). All 50 participants completed the study. Everyone in both groups received a medication called dalteparin, a blood-thinning injection commonly used after surgery to reduce the risk of blood clots. The trial was measuring wound complications after surgery, blood clot events, and the amount of blood transfusion needed following the operation. The reported data shows that, for post-surgical wound complications — which included wound opening (dehiscence), infection, and fluid build-up (seroma) — 1 person in the metastatic group and 4 people in the sarcoma group experienced at least one complication overall. Breaking that down further, wound opening was recorded for 0 people in the metastatic group and 3 in the sarcoma group, and seroma (fluid build-up) occurred in 0 people in the metastatic group and 1 in the sarcoma group. For blood clot events in the legs or lungs after surgery, the reported data shows 1 person in the metastatic group and 0 in the sarcoma group experienced such an event. Regarding blood transfusions after surgery, the reported data shows the metastatic group received an average of 213 mL of packed red blood cells, while the sarcoma group received an average of 271 mL. No further breakdown of this figure was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00642954 · results posted 18 November 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total across five different dose groups. Each group received a combination of two medicines — vorinostat and lenalidomide — at different dose levels, ranging from lower to higher amounts. The trial was an early-phase study primarily designed to look at serious side effects linked to the dose (called "dose-limiting toxicities"), as well as any unwanted effects that appeared to be related to the study medicines. Only 1 person out of all 31 completed the study; the remaining 30 did not complete it. The reported data shows that when it came to the main thing being measured — serious dose-related side effects — none of the participants in the four lower-dose groups experienced these, while 1 out of 17 participants in the highest-dose group (vorinostat 400 mg plus lenalidomide 25 mg) did. For the secondary measure — any unwanted effects judged by doctors to be related to the study medicines — the reported numbers were: 2 out of 4 participants in the lowest-dose group, 3 out of 4 in the next group, 3 out of 3 in the third group, 3 out of 3 in the fourth group, and all 17 out of 17 in the highest-dose group. The reported data for tumour response (how the disease responded) was only partially available in the submitted results, with very small numbers reported across groups, and full response data was not reported for all participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02335983 · results posted 6 November 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people across six groups. Participants had either relapsed or refractory multiple myeloma (a blood cancer that had come back or stopped responding to previous treatment, referred to as RRMM) or newly diagnosed multiple myeloma (NDMM). They received the drug carfilzomib at different dose levels — 56 mg/m² or 70 mg/m² — and were split into smaller "dose-finding" groups and larger "dose-expansion" groups. The trial was primarily measuring safety-related information, including tracking unwanted medical events (called adverse events) and monitoring changes in several blood and body chemistry levels over time. The reported data shows that across all six groups, every participant experienced at least one adverse event. When looking specifically at serious adverse events — meaning events that were fatal, life-threatening, required hospitalisation, or caused significant disability — the numbers ranged from 5 out of 9 participants up to 23 out of 34 participants, depending on the group. The reported data also shows changes in blood measurements from the start of the trial to later timepoints. Haemoglobin levels (a measure of red blood cells) showed small average decreases across all groups, ranging from about −0.9 to −5.6 g/L. Platelet counts (cells that help blood clot) generally decreased in most groups, with the largest average drop being around 51 units in two of the groups, while one group showed a very small average increase. Neutrophil counts (a type of white blood cell involved in fighting infection) showed only small average changes across groups. Bilirubin (a liver-related marker) and creatinine (a kidney-related marker) both showed only small average changes from baseline across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01102426 · results posted 22 October 2020
According to the results reported on ClinicalTrials.gov, this trial involved 255 people with multiple myeloma (a type of blood cancer) that had returned or stopped responding to previous treatment. Participants were divided into two groups: 171 people received a combination of plitidepsin and dexamethasone (two medicines), while 84 people received dexamethasone alone. The trial was primarily measuring "progression-free survival" — that is, how long participants went without their disease getting worse. The reported data shows that, for the primary outcome, the median time without disease progression was 2.6 months in the combination group compared to 1.7 months in the dexamethasone-only group. Median means half the participants in each group reached that point sooner, and half took longer. When looking at how many people were still progression-free at the six-month mark, the reported figures were 20% of the combination group and 10% of the dexamethasone-only group. For secondary outcomes, the reported data shows a median overall survival (time from the start of the trial until death or last contact) of 11.6 months in the combination group and 8.9 months in the dexamethasone-only group. At the 12-month mark, 48.3% of the combination group and 42.1% of the dexamethasone-only group were reported as still alive. It is worth noting that only a small number of participants — 6 in the combination group and 3 in the dexamethasone-only group — were recorded as having completed the trial, with the large majority not completing it for various reasons. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT03158688 · results posted 11 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 466 people with multiple myeloma (a type of blood cancer). Participants were split into two groups: 154 people received two drugs — carfilzomib and dexamethasone (called "Kd") — and 312 people received those same two drugs plus a third, daratumumab (called "KdD"). The trial's main goal was to measure "progression-free survival," meaning how long participants went without their disease worsening or dying. The reported data shows that for the primary measure, 68 out of 154 participants in the Kd group and 110 out of 312 in the KdD group had a progression-free survival event recorded, while 86 (Kd) and 202 (KdD) had their data noted in a different way (censored, meaning the event had not yet occurred at the time of analysis). For secondary measures, the reported overall response rate — the proportion of people whose disease showed at least a partial reduction — was about 74.7% in the Kd group and 84.3% in the KdD group. The reported median overall survival (the point at which half the participants in each group had passed away) was 43.6 months for the Kd group and 50.8 months for the KdD group. A measure called "MRD-negative complete response at 12 months" — meaning no detectable cancer cells at a very sensitive level plus a full response — was reported in 1.9% of the Kd group and 12.8% of the KdD group. The median duration of response (how long a response lasted) was reported as 16.6 months in the Kd group; for the KdD group this figure was not yet reached at the time of reporting. The reported data also shows that side effects during treatment (called treatment-emergent adverse events) were recorded in 147 of 153 treated participants in the Kd group and 306 of 308 in the KdD group. Severe or life-threatening side effects were recorded in 70 (Kd) and 173 (KdD) participants respectively. These numbers describe what was observed and recorded during the trial and do not on their own indicate whether one approach is better or worse than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00534118 · results posted 26 August 2020
According to the results reported on ClinicalTrials.gov, this trial involved 39 people in total — 17 in a "Multiple DLI" group and 22 in a "Single DLI" group. DLI stands for donor lymphocyte infusion, a procedure where immune cells from a bone marrow donor are given to a patient after a transplant. The trial was measuring how many participants went into or stayed in complete remission (meaning no detectable disease) after receiving DLI, how long that remission lasted, and whether participants developed a serious complication called graft-versus-host disease (where donor immune cells attack the recipient's body). The reported data shows that in the Multiple DLI group, 8 out of 17 participants achieved complete remission, compared with 6 out of 22 in the Single DLI group. Among those who did reach complete remission, the reported average duration of remission was 10.1 months for the Multiple DLI group and 9 months for the Single DLI group, both measured up to a maximum follow-up of 12 months. Regarding the serious complication of severe graft-versus-host disease (graded as III–IV, meaning more serious forms), the reported data shows that 0 participants in the Multiple DLI group and 4 participants in the Single DLI group developed this condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03277105 · results posted 27 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03277105) enrolled 522 people with a type of blood cancer called multiple myeloma — 259 in a group receiving daratumumab given through a drip into a vein (intravenous, or IV), and 263 in a group receiving daratumumab given as an injection under the skin (subcutaneous, or SC). The trial had two main goals: to compare how much of the drug built up in the bloodstream between the two delivery methods, and to measure how many participants showed a meaningful reduction in signs of their disease (called the overall response rate). The reported data shows that, looking at drug levels in the blood, the SC group had a higher peak trough concentration (the amount of drug measured in the blood just before the next dose) — 611 micrograms per millilitre, compared with 525 in the IV group. For the overall response rate — the proportion of participants whose disease showed at least a partial reduction — 43.3% of the SC group and 39.4% of the IV group met that threshold. Among secondary measurements, the reported data shows that 34.5% of IV participants and 12.7% of SC participants experienced infusion-related reactions (side effects occurring around the time of receiving the treatment). The median time before disease progression or death was reported as approximately 6.1 months in the IV group and 5.6 months in the SC group. Deeper levels of response (called very good partial response or better) were recorded in 21.6% of the IV group and 23.6% of the SC group, while the highest response category (complete response or better) was reported in 5.4% and 4.6% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00303719 · results posted 12 May 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 342 people in total — 13 classified as "high risk" patients and 329 classified as "standard risk" patients. The trial was examining a type of stem cell transplant procedure, and was measuring whether participants' bodies successfully accepted donor cells (known as engraftment), as well as tracking a number of other outcomes including survival, deaths related to the transplant itself, serious unwanted health events, and a transplant complication called graft-versus-host disease (where donor cells attack the recipient's body). The reported data shows that, for the primary goal of successful donor cell engraftment, 12 out of 13 high risk participants and 289 out of 329 standard risk participants met the defined criteria by the specified timepoints. For the secondary outcomes, the reported data shows that serious adverse events (significant unwanted health events) within 100 days occurred in 0 of the 13 high risk participants and 47 of the 329 standard risk participants. Deaths related to the transplant procedure were reported for 2 high risk and 40 standard risk participants. Overall survival figures were reported as 8 out of 13 high risk participants and 181 out of 329 standard risk participants. Severe graft-versus-host disease (grades III–IV, meaning serious to life-threatening) was reported in 2 high risk and 79 standard risk participants. It is worth noting that 37 standard risk participants did not complete the study, though the reasons were not reported in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03525678 · results posted 28 April 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03525678) tested a medicine called GSK2857916 (also known as belantamab mafodotin) in people with multiple myeloma — a type of blood cancer. The trial looked at different doses and two different forms of the medicine (a frozen liquid and a freeze-dried powder called lyophilised). In the main part of the study, 97 people received the 2.5 mg/kg frozen liquid dose, 99 received the 3.4 mg/kg frozen liquid dose, and 25 received the 3.4 mg/kg lyophilised form. A very small number of participants (3 people in total) continued into a longer follow-up phase. The trial's main goal was to measure the "overall response rate" — that is, the proportion of participants whose disease showed a meaningful reduction according to standard criteria assessed by an independent review panel. The reported data shows that, when assessed by the independent review panel across all participants in the main study, 31% of those on the 2.5 mg/kg frozen liquid, 34% on the 3.4 mg/kg frozen liquid, and 48% on the 3.4 mg/kg lyophilised form met the criteria for a response (meaning at least a partial reduction in measurable disease). When looking at a specific pre-defined group of the first 130 participants receiving the frozen liquid forms, the independent panel reported a response rate of 30% in both dose groups. Assessments made by the treating doctors rather than the independent panel showed broadly similar figures — ranging from 26% to 52% depending on the group and dose. The reported data also shows a measure called "clinical benefit rate," which counted anyone showing at least a minimal reduction in disease. Across the main study groups, the doctors' assessments put this figure at 35% for the 2.5 mg/kg frozen liquid group, 38% for the 3.4 mg/kg frozen liquid group, and 60% for the lyophilised group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01413178 · results posted 21 April 2020
According to the results reported on ClinicalTrials.gov, this trial involved 205 people with multiple myeloma (a type of blood cancer). Participants were split into two groups: 105 people received a combination of two chemotherapy drugs called busulfan and melphalan before a stem cell transplant, while 100 people received melphalan alone. The trial was primarily measuring how many people in each group were still alive and had no signs of their myeloma returning three years after their transplant — this is called "progression-free survival." Several additional measures were also tracked, including overall survival, complete response rates (a measure of how thoroughly the myeloma appeared to clear), deaths related to treatment, and serious side effects. The reported data shows that for the main measure — being alive and disease-free at three years — 72 out of 105 participants in the busulfan-plus-melphalan group and 50 out of 100 participants in the melphalan-only group met this outcome. For overall survival at the study's end, the reported figures were 91 out of 105 participants in the busulfan-plus-melphalan group and 79 out of 100 in the melphalan-only group. Regarding complete response (where the myeloma appeared to clear fully, checked 90 days after transplant), 12 participants in the busulfan-plus-melphalan group and 15 in the melphalan-only group met that definition. The reported data shows that no deaths related to the treatment itself were recorded in either group. Serious side effects (graded 3–4, meaning significant in severity) were reported across several categories, with numbers varying between the two groups; however, the specific category labels for each set of figures were not included in the submitted data, so a full breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02252172 · results posted 9 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02252172) enrolled 737 people in total — 369 in one group and 368 in another. Participants were randomly assigned to receive either a two-drug combination (lenalidomide plus dexamethasone, called "Rd") or a three-drug combination that added daratumumab to those same two medicines (called "DRd"). The trial's main goal was to measure "progression-free survival" — that is, how long participants went without their disease worsening or without dying. The reported data shows that for the Rd (two-drug) group, the median progression-free survival was approximately 31.87 months. For the DRd (three-drug) group, a median figure was not yet reached at the time results were submitted, meaning the data was not fully available to report a final number. For the secondary outcomes — which looked at how deeply participants responded to treatment — the reported data shows the following percentages of participants in each group who reached various response levels: an "overall response" (any meaningful reduction in disease markers) was seen in 81.6% of the Rd group and 92.9% of the DRd group; a "very good partial response or better" (a deeper level of reduction) was seen in 56.9% versus 81.5%; a "complete response or better" (no detectable disease by standard tests) was seen in 30.1% versus 51.1%; a "stringent complete response" (the deepest standard category) was seen in 15.7% versus 35.6%; and "minimal residual disease negativity" (an even more sensitive test for remaining disease, measured only in those who achieved a complete response) was reported in 11.1% versus 32.1%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00003270 · results posted 13 December 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all in a single treatment group. All 20 participants completed the study. The trial was measuring how people with a blood cancer responded to treatment — specifically, whether they either stayed in complete remission (meaning no sign of disease) if they were already in remission before the trial, or whether those who were not in remission went into complete remission after treatment. The reported data shows that out of the 20 participants, 12 maintained a continuous complete remission, 1 achieved a newly induced complete remission, and 7 did not meet either of those responses. For the secondary outcome — progression-free survival, which tracks the percentage of participants who did not experience their disease getting worse or who did not die from any cause over the follow-up period — the reported figure was 50% of participants. It is worth noting that the data as submitted does not include information about the timeframe over which progression-free survival was measured, so that detail cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02990338 · results posted 6 December 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02990338) enrolled 307 people with a type of blood cancer called multiple myeloma who had already received prior treatments. Participants were randomly assigned to one of two groups: 153 people received a two-drug combination (pomalidomide and dexamethasone, called "Pd"), and 154 people received a three-drug combination that added isatuximab to those same two drugs (called "IPd"). The trial was primarily measuring how long people went without their disease getting worse — known as "progression-free survival" — and also tracked a range of other measures including how many people's disease responded to treatment and how long people lived overall. The reported data shows that, for the primary measure of progression-free survival, the Pd group had a reported median of 6.47 months before disease worsening or death, compared to 11.53 months in the IPd group. (A "median" means half the people in that group reached that point sooner, and half took longer.) For overall survival — meaning time from the start of the trial until death from any cause — the reported median was 17.71 months in the Pd group and 24.57 months in the IPd group. The reported data also shows that 35.3% of participants in the Pd group and 60.4% in the IPd group had a measurable response to treatment, while a deeper level of response (called "very good partial response or better") was reported in 8.5% of the Pd group and 31.8% of the IPd group. Clinical benefit (any meaningful reduction in disease markers) was reported in 46.4% of the Pd group and 66.9% of the IPd group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01772719 · results posted 18 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01772719) enrolled 7 participants, all of whom received a combination of two medicines — simvastatin and zoledronic acid. The trial was designed to look at how this combination might affect certain proteins in the blood (called M-protein and free light chain ratio) that are linked to a type of blood cancer called myeloma, as well as to track how long participants survived and whether their condition stayed stable over time. The reported data shows that none of the 7 participants completed the trial — all 7 did not finish it. Beyond that, no numerical results were reported for any of the outcome measures, including the main measure (changes in those blood protein levels) or any of the secondary measures such as overall survival, time without disease progression, or duration of response. In other words, the fields where result figures would normally appear were left empty in the submitted data, so no findings from these measurements can be described. Because no outcome data was submitted, it is not possible to draw any conclusions from this trial about what the treatment combination did or did not do. The reasons the trial ended early and why results were not reported are not explained in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01045460 · results posted 8 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people with multiple myeloma — 17 in one group and 18 in another. Both groups received a stem cell transplant along with a treatment called MILs (a type of immune cell collected from the patient's own bone marrow). The second group also received a myeloma vaccine in addition to MILs. The trial was measuring how well participants' disease responded to treatment, how long they lived without their disease getting worse, and how long they survived overall. The reported data shows that, when looking at disease response in the group receiving the transplant plus MILs alone, 2 people achieved a complete response, 3 a near-complete response, 1 a very good partial response, and 4 a partial response. In the group that also received the vaccine, 5 achieved a complete response, 2 a near-complete response, 1 a very good partial response, and 5 a partial response. For how long participants lived without their disease progressing (called progression-free survival), the reported median was 15.5 months for the MILs-only group and 18.6 months for the MILs-plus-vaccine group. At five years, 7 out of 17 participants in the MILs-only group and 9 out of 18 in the vaccine group were reported as still alive. Regarding serious side effects (graded 3–5 on a standard severity scale), none were reported in the MILs-only group and 1 was reported in the vaccine group. The anti-tumour immune response data was not reported in the structured results. The reported data also shows that 3 participants in each group withdrew or were removed from the study for reasons other than the treatment not working, before the study was completed. It is worth noting that not all participants finished the study — 11 of 17 completed in the MILs-only group, and 15 of 18 in the vaccine group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02064387 · results posted 26 September 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02064387) tested a drug called GSK2857916 in people with either multiple myeloma (MM — a type of blood cancer) or non-Hodgkin lymphoma (NHL). The trial ran in two parts. Part 1 enrolled 38 people with multiple myeloma across ten different dose levels, starting very low and gradually increasing, to find out how the body handled the drug. Part 2 then enrolled a further 35 people with multiple myeloma and 6 people with non-Hodgkin lymphoma, all receiving the same dose (3.40 mg/kg). The trial was primarily measuring the number of participants who experienced serious medical events (called serious adverse events, or SAEs) and any other medical events that occurred in 5% or more of participants, as well as looking at specific "dose-limiting toxicities" — meaning medical events serious enough that the dose could not safely be increased further. The reported data shows that in Part 1, across all ten dose groups combined, the number of participants counted for SAEs and common non-serious medical events ranged from 1 participant (in the two lowest dose groups) up to 8 participants (in the 2.50 mg/kg group). Importantly, the reported data shows that zero participants in any of the ten Part 1 dose groups experienced a dose-limiting toxicity during the first 21 days of treatment. In Part 2, the reported figures show that of the 35 multiple myeloma participants, 35 were counted in the SAE/common events analysis, with 17 also reported in a second measurement category; for the 6 NHL participants, 6 were counted in the first category and 3 in the second. The reported data also shows that changes in blood pressure readings from the starting point were recorded — for example, in Part 2's multiple myeloma group, 30 and 31 participants (out of 35) showed a worsening in their diastolic and systolic blood pressure grades respectively at some point during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02046070 · results posted 17 July 2019
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of three medicines — ixazomib, cyclophosphamide, and dexamethasone — in people with multiple myeloma (a type of blood cancer). There were two groups of newly diagnosed patients (36 people on a lower dose of cyclophosphamide, and 34 on a higher dose) and one group of 78 people whose myeloma had come back or stopped responding to previous treatment. The trial was measuring how many participants showed a meaningful reduction in cancer markers during treatment, as well as tracking unwanted medical events that occurred along the way. The reported data shows that, among newly diagnosed participants, 27% in the lower-dose group and 24% in the higher-dose group achieved what the trial defined as a "combined response" — meaning their cancer markers fell to a very good or complete level during the early treatment phase. When a broader measure of response (including partial responses) was used across the full treatment period, the reported figures rose to 82% and 71% respectively for those two groups. For the group whose myeloma had returned or stopped responding, the reported overall response rate was 49%. The reported data also shows that the first signs of a response appeared at around 2.2 months in the lower-dose newly diagnosed group and 1.9 months in the higher-dose group. Regarding unwanted medical events in the newly diagnosed groups, the reported data shows that out of 36 and 34 participants respectively, 35 and 34 experienced at least one adverse event; 27 and 27 experienced a grade 3 or higher (more serious) adverse event; and 17 and 20 experienced what were classified as serious adverse events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02654132 · results posted 3 June 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02654132) enrolled 117 people with a type of blood cancer called multiple myeloma. Participants were divided into two groups: 60 people received a combination called E-Pd (elotuzumab plus pomalidomide and dexamethasone), and 57 people were assigned to Pd (pomalidomide and dexamethasone without elotuzumab). The trial was primarily measuring how long participants went without their disease getting worse, and also looked at how many people's disease responded to treatment and how long people lived overall. The reported data shows that for the main measure — the time from the start of the study until disease progression or death (called progression-free survival) — the E-Pd group had a reported figure of around 10.25 months, compared to 4.70 months in the Pd group. For the secondary measures, the proportion of participants whose disease showed a meaningful response to treatment (called the objective response rate) was reported as 58.3% in the E-Pd group and 24.6% in the Pd group. The reported data also shows that the time from the start of the study until death from any cause (called overall survival) was 29.80 months in the E-Pd group and 17.41 months in the Pd group. It is worth noting that the data as submitted does not include additional statistical detail beyond these figures, so further context about how these numbers were analysed was not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02181413 · results posted 7 May 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 656 people in total — 261 received a placebo and 395 received a tablet called ixazomib citrate. The trial was measuring how long people went without their condition getting worse (called "progression-free survival"), as well as a number of other time-related outcomes such as overall survival, how long before needing a next treatment, and response to treatment. Of those who started, 206 in the placebo group and 322 in the ixazomib citrate group completed the study. The reported data shows that for the main outcome — the time from when someone joined the trial until their condition progressed or they died — the placebo group had a reported median (the midpoint value in the group) of 21.3 months, while the ixazomib citrate group had a reported median of 26.5 months. For the secondary outcomes, the reported median time until disease progression alone (not including death) was 21.4 months for placebo and 26.6 months for ixazomib citrate. The reported median time before needing a next treatment was 27.6 months for placebo and 33.1 months for ixazomib citrate. For a combined measure tracking progress through a second round of treatment, the reported figures were 80.4 months for placebo and 84.0 months for ixazomib citrate. Overall survival figures were not reported in the submitted data. For treatment response categories, the reported data shows broadly similar proportions across both groups, though the exact breakdown across response levels (partial, very good partial, and complete response) showed only small numerical differences between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01927718 · results posted 29 April 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01927718) enrolled 10 participants, all of whom completed the study with no dropouts. All participants received a combination of two medicines — thalidomide and lenalidomide. The trial was measuring how many people responded to this combination, where "response" was defined as their disease either stabilising or returning to at least the level it was at before it had progressed — assessed at three months after starting the combination. The reported data shows that out of the 10 participants, 2 met the criteria for a response at that three-month assessment point. The trial used several categories to measure response, ranging from a full disappearance of disease markers (called Complete Remission) through to partial improvements and stable disease. The results submission reports the total number who responded as 2, but does not break down how many participants fell into each individual response category. Data for any secondary outcome measures was not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02548962 · results posted 23 April 2019
According to the results reported on ClinicalTrials.gov, this was a small Phase 1 dose-finding trial (registered as NCT02548962) that enrolled 11 people in total — 8 in a group receiving a 560 mg dose and 3 in a group receiving an 840 mg dose. The trial was measuring how participants' conditions responded to the treatment at these two different dose levels, using standard criteria set by an international myeloma working group (IMWG). Of the 11 who started, 10 completed the study (7 in the 560 mg group and all 3 in the 840 mg group). The reported data shows that for the main measure — called the Overall Response Rate, meaning the number of people whose condition showed at least a partial response to treatment — 3 out of 8 participants in the 560 mg group and 1 out of 3 in the 840 mg group met this threshold. For a broader measure called Clinical Benefit Response (which also counted people with smaller, more modest responses), the reported data shows 4 out of 8 participants in the 560 mg group and 2 out of 3 in the 840 mg group were counted. For those who did respond, the reported data shows the response lasted a median (middle value) of 6.5 months in the 560 mg group and 7.3 months in the 840 mg group, though it should be noted this is based on very small numbers of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02632786 · results posted 5 April 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02632786) enrolled 129 participants in total — 66 received the investigational drug NEOD001 (at a dose of 24 mg/kg) and 63 received a placebo (an inactive treatment). The trial was measuring several things over 12 months, with the main focus being whether participants' hearts showed a response based on a blood marker called NT-proBNP, which can reflect how much stress is on the heart. Secondary measurements included physical quality of life, how far participants could walk in six minutes, kidney response, nerve function in the lower limbs, and how the NT-proBNP blood marker changed over time. The reported data shows that for the primary (main) outcome — heart response based on NT-proBNP — 26 out of 66 participants in the NEOD001 group showed a response, compared with 30 out of 63 in the placebo group. The remaining participants in each group (40 and 33 respectively) did not show a response. For the secondary outcomes, the reported data shows: the physical quality-of-life score (on a scale where higher means less difficulty) changed by an average of 0.19 points in the NEOD001 group and 0.97 points in the placebo group; the six-minute walk test distance changed by an average of 19.25 metres in the NEOD001 group and 8.00 metres in the placebo group. For kidney response (measured in participants with kidney involvement), 7 out of a subset in the NEOD001 group responded versus 6 in the placebo group, while 6 in the NEOD001 group and 12 in the placebo group did not respond. The nerve function score (where lower numbers mean less impairment) changed by an average of −1.2 in the NEOD001 group and −0.6 in the placebo group. Finally, the rate of change in the NT-proBNP blood marker was reported as 9.45 units per infusion in the NEOD001 group and 81.41 units per infusion in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02412878 · results posted 13 December 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02412878) enrolled 478 people with a type of blood cancer called multiple myeloma — 238 in one group and 240 in another. Both groups received a drug called carfilzomib combined with a steroid called dexamethasone, but on different dosing schedules: one group received carfilzomib twice a week at a lower dose, and the other received it once a week at a higher dose. The main thing the trial was measuring was how long participants went without their disease getting worse (called "progression-free survival"). Researchers also tracked how many people responded to treatment, how long people survived overall, and what side effects occurred. The reported data shows that, for the main measure, participants in the twice-weekly lower-dose group went a middle-point (median) of 7.6 months before their disease progressed or they died, while those in the once-weekly higher-dose group reached a median of 11.2 months. For the response measure — meaning the proportion of people whose disease showed a meaningful reduction — the reported figures were 40.8% in the twice-weekly group and 62.9% in the once-weekly group. For overall survival (how long people lived), the data was reported as "not available" for both groups at the time of reporting, meaning a final figure was not yet able to be calculated. Regarding side effects, the reported data shows that the large majority of participants in both groups experienced adverse events of some kind, with varying numbers experiencing more serious events, though the full breakdown of individual side-effect categories was not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00869206 · results posted 7 November 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,822 people in total — 911 in each group. Participants had either metastatic breast cancer, metastatic prostate cancer, or multiple myeloma (a type of blood cancer) that had spread to the bones. The trial compared two different schedules of a bone-strengthening infusion called zoledronic acid: one group received it every 4 weeks, and the other received it every 12 weeks. The main thing the trial was measuring was how many people in each group experienced at least one "skeletal-related event" — meaning a bone fracture, the need for radiation or surgery to the bone, or a similar bone complication — within two years of joining the trial. The reported data shows that 67.6% of participants in the every-4-week group and 67.9% in the every-12-week group experienced at least one skeletal-related event within two years — a very similar figure between the two groups. The trial also measured pain scores using a questionnaire rated from 0 (no pain) to 10 (worst pain): the average reported score was 2.06 in the every-4-week group and 2.09 in the every-12-week group. A measure of how well participants were able to carry out daily activities (scored 0–5, where 0 means fully active) averaged 0.82 in the every-4-week group and 0.84 in the every-12-week group. The rate of bone complications per year was reported as 0.4 in both groups. The reported data also shows figures for two specific complications. A jaw bone condition called osteonecrosis of the jaw was reported in 2.0% of the every-4-week group and 1.0% of the every-12-week group. Serious kidney problems were reported in 1.2% of the every-4-week group and 0.5% of the every-12-week group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01852799 · results posted 10 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 adults with multiple myeloma (a type of blood cancer affecting plasma cells). All participants received a treatment combination called PAD (a chemotherapy and medication regimen) followed by a stem cell transplant using their own cells (known as ASCT). The trial was measuring changes in certain proteins in the blood linked to bone health — specifically one that signals new bone growth (called bone alkaline phosphatase, or bALP) and one that can block bone formation (called DKK-1) — as well as bone density, bone-related complications, and how participants' cancer responded to treatment. The reported data shows that none of the 18 participants were recorded as having "completed" the trial under the study's own completion criteria, with all 18 listed in the "not completed" category. The reported data shows a series of bALP measurements (the bone formation marker) at different time points, with values ranging from approximately 1.33 to 28.75 U/L, alongside DKK-1 readings ranging from roughly 1,589 to 4,765 (units not separately clarified in the submission). For bone mineral density and skeletal-related events (such as fractures or need for surgery), no numerical results were reported in the submission. Regarding how participants' cancer responded to treatment, the reported figures show 4 participants recorded as achieving a complete response, 12 recorded as a partial response, 1 with minimal response, and 1 with stable disease, with 0 recorded as having progressive disease — though the submission lists these figures twice, and the reason for the duplication is not explained in the data. The reported median progression-free survival (the length of time, on average, before the disease worsened) was 13.7 months. For participant safety evaluations, the reported data shows numbers of participants (ranging from 10 to 15) recorded at various assessment points, though the specific nature of each recorded safety observation is not fully detailed in the submitted figures. It is important to note that these numbers describe what was measured and counted in this particular group — they do not tell us how these results compare to other treatments or what they would mean for any individual person. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02720510 · results posted 24 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02720510) enrolled a total of 6 people — 3 in a group receiving a combination of panobinostat with bortezomib, lenalidomide, and dexamethasone (sometimes called P-RVD or RVD + Pan), and 3 in a group receiving bortezomib, lenalidomide, and dexamethasone alone (RVD). The trial was set up to compare these two treatment combinations in people newly diagnosed with multiple myeloma, a type of blood cancer. It aimed to measure things like how deeply the cancer responded to treatment, how long responses lasted, and whether patients survived longer. The reported data shows that none of the 6 participants completed the study — all 3 in each group are recorded as "not completed." Importantly, no numerical results were submitted for any of the outcome measures, including the primary goal of measuring near-complete or complete response rates, or any of the secondary goals such as minimal residual disease (a measure of very small amounts of remaining cancer), overall response rates, depth of response, duration of response, or overall survival. In other words, the data for what the trial was actually trying to measure was not reported on ClinicalTrials.gov. Given that the trial appears to have stopped very early with only 6 participants and no completed participants, it is not possible to draw any conclusions from this trial about the treatments being studied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02224729 · results posted 7 June 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, and all 24 completed the study. There was one group, and everyone received the same combination of three medicines: bendamustine, bortezomib, and dexamethasone (referred to as BBd). The trial was primarily measuring how many participants showed an overall response — meaning at least a partial reduction in their cancer — after four cycles of this treatment combination. It also tracked side effects and longer-term outcomes such as survival. The reported data shows that 13 out of 24 participants met the definition of an "overall response" after four treatment cycles. Of those, 9 participants were reported to have achieved what the trial called a "very good partial remission" — meaning their cancer markers had dropped by more than 90% or were barely detectable by standard blood and urine tests. Regarding side effects, the reported data shows 22 grade 3–4 adverse events were recorded across the group (grade 3–4 refers to severe or life-threatening side effects on a standard medical rating scale). It is worth noting this figure counts events, not individual people, so one person may have experienced more than one such event. For the longer-term outcomes, the reported data shows that 2 out of 24 participants were alive and free from worsening disease one year after treatment, and separately, 2 out of 24 participants were reported to have survived at least one year after completing treatment. These are small numbers, and the trial did not report further detail explaining these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00445692 · results posted 21 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people who received a combination of three medicines — clarithromycin, dexamethasone, and lenalidomide. The trial was measuring two main things: how long it took for participants' disease to get worse (called "time to disease progression"), and how many episodes of certain serious side effects occurred during treatment. Fifteen participants were recorded as completing the study, while 16 did not complete it. The reported data shows that the median time to disease progression — meaning the point at which half the participants had seen their disease worsen and half had not — was 30.5 months. Regarding side effects, the trial tracked several categories of serious episodes across the group. The reported numbers of episodes in each tracked category were: 6, 1, 1, 1, 4, 12, 3, 1, 3, 1, 3, and 10 — though the data as submitted does not label which number belongs to which specific side effect category, so a precise breakdown cannot be provided here. For the secondary outcome looking at survival, the reported data shows figures of 10, 1, 1, 1, and 18 participants across different survival-related categories, however the labels for each of these figures were not included in the submitted data, so a more detailed description cannot be given. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00569309 · results posted 12 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom completed the study with no dropouts. All participants received a vaccine called Prevnar (also known as PCV7), which targets a type of bacteria called *Streptococcus pneumoniae*. The trial was measuring how the immune system recovered after a stem cell transplant for myeloma (a type of blood cancer), looking at things like the body's response to the vaccine, certain immune cell activity, and quality of life. It was described as a pilot study, meaning it was designed to gather early information to inform future research. The reported data shows that all 30 participants were counted as having experienced immune reconstitution — that is, some level of immune system recovery was measured across the group. For quality of life, two standard questionnaires were used, both scored on a scale of 0 to 10 (where 0 means no problem and 10 means the worst imaginable). The reported average pain score, using a tool called the Brief Pain Inventory, was 2.8 out of 10. The reported average fatigue score, using the Brief Fatigue Inventory, was 2.55 out of 10. For the remaining secondary outcomes — including detailed measurements of specific immune cells called regulatory T-cells, and the link between quality of life and certain chemical signals produced by immune cells — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01345019 · results posted 7 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 859 participants in each group — one group received zoledronic acid and the other received denosumab — for a total of 1,718 people. The trial was measuring "skeletal-related events" (SREs), which means serious bone complications such as broken bones caused by cancer, radiation treatment to bone, bone surgery, or spinal cord compression. The main question the trial set out to answer was how long it took for participants to experience one of these bone complications, and how many participants experienced at least one. The reported data shows that, among participants who experienced an on-study skeletal-related event, the median time (meaning the midpoint — half of those affected reached this point sooner, half later) to a first such event was reported as 730 days for the zoledronic acid group and 695 days for the denosumab group. The reported data also shows that 44.6% of participants in the zoledronic acid group and 43.8% in the denosumab group experienced at least one skeletal-related event during the study. When a separate statistical method (called a Kaplan-Meier estimate, which accounts for participants who left the study early) was applied, the figures at various time points were broadly similar between the two groups, ranging from approximately 36% to 51% across both groups. For participants who went through both phases of the study, the average number of bone complication events per person was 0.66 in both groups, and the total number of events recorded was 565 in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01979276 · results posted 31 January 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01979276) enrolled 2 participants, all of whom completed the study. The trial was testing a combination of three medicines — romidepsin, pomalidomide, and dexamethasone — in people with multiple myeloma (a type of blood cancer) that had come back or stopped responding to earlier treatment. The trial had two planned stages: a first stage to find the highest dose of romidepsin that could be given alongside the other medicines without causing too many side effects, and a second stage to look at how patients' disease responded to the treatment combination. The reported data shows that for the primary goal of finding a maximum tolerated dose (the highest dose considered manageable), no numerical results were submitted to ClinicalTrials.gov. For the second primary goal — measuring how participants' disease responded — the reported data shows that out of the 2 participants, 1 achieved one category of response and 1 achieved another category of response; however, the specific response categories for each result were not labelled in the data provided, so the exact nature of each response cannot be described here. The reported data shows that for the secondary outcome — time to disease progression (meaning how long it was before the disease began to worsen again) — the figure reported was 9.5 cycles, where each cycle was defined as 28 days (roughly 9.5 months). Because only 2 people took part, this figure reflects a very small number of individuals and should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00349778 · results posted 12 December 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 102 participants, all of whom received a treatment approach called high-dose sequential therapy followed by an autologous transplant (where a person's own stem cells are collected and returned to them after high-dose treatment). All 102 participants who started the trial completed it. The trial was measuring three things: whether participants developed a specific type of lung inflammation called interstitial pneumonitis, how many participants were still alive five years after their transplant, and how many participants experienced a return of their illness after the transplant. The reported data shows that out of 102 participants, 32 were recorded as having developed the lung inflammation being monitored (interstitial pneumonitis). Regarding survival, the reported data shows that 52 out of 102 participants were alive at the five-year follow-up point after their transplant. The reported data also shows that 66 out of 102 participants experienced a return of their illness after the transplant procedure. It is important to note that this trial had only one group, meaning there was no comparison group receiving a different treatment, so these numbers describe what was observed in this particular group of participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01646762 · results posted 1 September 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, all of whom completed the study with no drop-outs. The trial was testing a chemotherapy treatment in patients with a blood cancer condition, and was primarily looking at how many people experienced at least a "partial response" — meaning a meaningful reduction in signs of disease — confirmed on two separate check-ups. It also tracked a number of secondary measures, including how long participants lived, how long they went without their disease getting worse, how long any response lasted, and what side effects occurred. The reported data shows that 7.7% of participants (roughly 1 in 13) achieved a confirmed partial response or better as the primary measure. The overall response rate — which counted responses that did not need to be confirmed twice — was reported as 15%. For survival, the reported median survival time (the point at which half the participants had passed away) was 3.7 months. Only 25.4% of participants were free from disease progression at the 3-month mark. Among those who did respond to treatment, the reported median duration of that response was 2.43 months. Regarding side effects, the reported data shows varying percentages of participants experienced serious adverse events (graded as severe or worse and considered at least possibly related to treatment), with individual event rates ranging from 7.7% to 38.5% across different categories — though the specific names of those individual side effects were not included in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00520130 · results posted 24 August 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 89 people who were receiving a stem cell (bone marrow) transplant from a donor. Participants were split into two groups: 44 people received a three-drug combination called TMS (tacrolimus, methotrexate, and sirolimus), and 45 people received a two-drug combination called AC (cyclosporine-based). The trial was measuring rates of a complication called graft-versus-host disease (GVHD) — a condition where donated immune cells attack the recipient's body — as well as how well the immune system rebuilt itself after the transplant. The reported data shows that for the short-term (acute) form of GVHD, 42% of participants in the TMS group and 38% in the AC group experienced a moderate-to-severe episode. For the longer-term (chronic) form of GVHD, the reported figures were 50% in the TMS group compared with 12% in the AC group for one measurement category, and 28% versus 5% for another. The trial also tracked the recovery of specific immune cells (called CD4 and CD8 T cells) at various time points after the transplant. The reported data shows that early on, the TMS group had notably higher percentages of a particular type of these immune cells (called "naïve" cells) compared with the AC group, though the numbers became more similar at later time points. The trial also measured how varied or diverse the immune cells' recognition toolkit was over time; lower scores indicate a healthier, more varied immune response. The reported data shows the TMS group generally had lower (more diverse) scores than the AC group at most time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00621244 · results posted 17 August 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 176 participants across four groups. The trial was testing different doses of a treatment given on two different schedules — one involving more frequent dosing (Arm 1) and one involving a less frequent, intermittent schedule (Arm 2). Each arm included two subgroups of patients: one with blood cancers called Acute Myelogenous Leukaemia (AML) or Myelodysplastic Syndromes (MDS) (Group X), and one with Hodgkin's Lymphoma (Group Y). The main thing the trial was measuring was the highest dose that could be given before too many participants experienced serious side effects — this is called the "maximum tolerated dose" or MTD. The reported data shows that in Arm 1 (the more frequent dosing schedule), the MTD for Group X was identified at 60 mg, with 1 participant at that dose level experiencing a dose-limiting side effect (a reaction serious enough to cap the dose). At 80 mg, 4 participants had such reactions. For Group Y in Arm 1, the MTD was reached at 40 mg, where 5 participants had dose-limiting reactions, and 4 more did at 60 mg. In Arm 2 (the intermittent schedule), no dose-limiting reactions were reported at lower doses, but 4 participants in Group X at 80 mg and 3 participants in Group Y at 60 mg experienced them, establishing those as the upper limits. For the secondary outcomes — which looked at how participants' disease responded — the reported data shows, for example, that among AML patients in Arm 1, 2 participants had a complete response, 1 had a partial response, 25 had stable disease, 17 had progressive disease or treatment failure, and the remainder were recorded in other categories. Similar response breakdowns were reported for Hodgkin's Lymphoma and MDS patients, though the numbers were smaller. It is also noted that a planned second stage of the trial did not open for enrolment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00689936 · results posted 11 August 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT00689936) enrolled 1,623 people with a type of blood cancer called multiple myeloma who had not previously been treated. Participants were split into three groups: one group received lenalidomide plus low-dose dexamethasone continuously (Rd, 535 people); a second group received the same two medicines but only for 18 cycles (Rd18, 541 people); and a third group received a different combination of three medicines — melphalan, prednisone, and thalidomide (MPT, 547 people). The trial's main goal was to measure how long participants went without their disease getting worse (called "progression-free survival"), and it also tracked how long participants lived overall, how many showed a measurable response to treatment, and how long that response lasted. The reported data shows that, for the main measure — time without disease worsening — the continuous Rd group went a median of approximately 25–26 months, the Rd18 group approximately 21 months, and the MPT group approximately 21–22 months (two different review methods gave slightly different figures for each group). For overall survival — how long participants lived — the reported median figures were approximately 59 months for the continuous Rd group, 62 months for the Rd18 group, and 49 months for the MPT group. Regarding the proportion of participants who showed a measurable response to treatment, the reported data shows roughly 75–81% in the continuous Rd group, 73–79% in the Rd18 group, and 62–68% in the MPT group, depending on which review method was used. The reported median duration of that response was approximately 35 months for the continuous Rd group, and approximately 22 months for both the Rd18 and MPT groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00448357 · results posted 17 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 54 participants, all of whom completed the study. The trial was investigating a stem cell transplant preparation regimen that used a chemotherapy drug called busulfan, given by continuous intravenous (drip) infusion alongside other medicines, for people with blood-related conditions. One of the key things the trial was trying to work out was the right dose of busulfan — specifically, whether a small "test dose" could be used to predict and personalise the full dose for each patient, and what the highest dose was that patients could tolerate without serious side effects. The reported data shows that when it came to serious side effects linked to the busulfan infusion (called "dose-limiting toxicities"), between one and two such events were recorded at each of the five dose levels tested. For the question of whether the test dose could accurately predict each patient's actual drug exposure during full treatment, the reported margin of error ranged from about 5% to 16% across the five dose levels. Participants were then grouped into three categories based on how much drug their body was actually exposed to (low, intermediate, and high). The reported data shows that three-year relapse-free survival — meaning the percentage of people alive and without their disease returning after three years — was 22% in the low-exposure group, 39% in the intermediate group, and 43% in the high-exposure group. For overall survival at three years, the reported figures were 28%, 39%, and 55% across the low, intermediate, and high exposure groups respectively. Regarding a complication called graft-versus-host disease (where the donated cells react against the recipient's body), the reported data shows it occurred in varying numbers of participants across the three exposure groups, though the breakdown of mild, moderate, and severe cases was not clearly separated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01215344 · results posted 28 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people in total across two treatment groups. The larger group of 33 participants received a combination called VRD (made up of three medicines: bortezomib, lenalidomide, and dexamethasone), while 3 participants received a different combination called VDD (bortezomib, liposomal doxorubicin, and dexamethasone). The trial was looking at something called "minimal residual disease" (MRD) — a measure of how many cancer cells remain in the body at a very low level, detected by a specialised laboratory test. Specifically, it tracked whether patients who still had detectable cancer cells after their initial treatment went on to have those cells become undetectable after a stem cell transplant. The reported data shows that among the VRD group, 30% of patients who had detectable remaining cancer cells at the end of their initial treatment were reported to have those cells become undetectable by day 100 after their stem cell transplant. No equivalent figure was reported for the VDD group. For a secondary measure — how long patients went without their disease getting worse — the reported data shows that those whose cancer cells were undetectable at day 100 had a reported progression-free period of approximately 2.64 years. A figure for patients whose cancer cells remained detectable at day 100 was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01615029 · results posted 14 April 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01615029) enrolled 45 people in total who had multiple myeloma (a type of blood cancer). The study was split into two stages. In Phase 1, 13 participants were given the drug daratumumab at one of four different doses (2, 4, 8, or 16 milligrams per kilogram of body weight), always combined with two other medicines called lenalidomide and dexamethasone. The goal of Phase 1 was to look at how many participants showed a measurable response to the treatment combination. In Phase 2, a further 32 participants all received the highest dose (16 mg/kg daratumumab) with the same two companion medicines, and the main thing being measured was again the proportion of participants who showed a response. The reported data shows that in Phase 1, the proportion of participants recorded as having a response varied by dose group: 100% in the 2 mg/kg group (3 people), 100% in the 4 mg/kg group (3 people), 75% in the 8 mg/kg group (4 people), and 66.7% in the 16 mg/kg group (3 people). Across all Phase 1 participants combined, the reported response rate was 85.4%. In Phase 2, the reported response rate among the 32 participants receiving the 16 mg/kg dose was 81.3%. For Phase 1, the time until a first response was recorded ranged from approximately 1 month to just over 2 months depending on the dose group, while the time to the best response recorded ranged from approximately 1.9 months to around 16.7 months across groups. In Phase 2, the time to first response was reported as approximately 1 month, and the time to best response was reported as approximately 6.95 months. The reported data shows that two secondary outcomes — how long responses lasted (duration of response) and time to disease progression in Phase 2 — were listed as "NA" (not available), meaning those figures were not reported in the submitted data. It is worth noting that the Phase 1 dose groups each contained only a very small number of people (3–4 per group), so the percentage figures for those groups reflect the outcomes of just a handful of individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01313897 · results posted 13 April 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01313897) enrolled 10 participants, all in a single treatment group. The trial was measuring whether an expanded natural killer cell infusion — a type of treatment using immune cells — could produce a meaningful response in people with multiple myeloma (a blood cancer affecting plasma cells in the bone marrow). Eight of the 10 participants completed the study, while two did not complete it; the reasons were not detailed in the data provided. The main thing the trial was set up to measure was called "therapeutic efficacy" — specifically, how many participants showed at least a "partial response" within 180 days of receiving the cell infusion. A partial response was defined using a recognised set of criteria (from the European Society for Blood and Marrow Transplantation), which required meaningful reductions in markers of the disease, such as a 50% or greater reduction in abnormal proteins in the blood or plasma cells in the bone marrow. The reported data shows that 1 out of 10 participants met this threshold. No other outcome measures appear to have been reported in the submitted data. It is worth noting that this was a very small trial, and the data as submitted to ClinicalTrials.gov includes only the one outcome measure described above — any other measurements that may have been taken during the study were not reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00513474 · results posted 11 April 2017
According to the results reported on ClinicalTrials.gov, this trial looked at whether a medicine called rasburicase might reduce the occurrence of a complication called acute graft-versus-host disease (aGVHD) — a condition that can happen after a bone marrow or stem cell transplant, where donated immune cells attack the recipient's body. A total of 25 people were assigned to the rasburicase group and 21 to a control group (who did not receive rasburicase), giving 46 participants in all. Not everyone completed the trial — 18 people in the rasburicase group and 12 in the control group finished. The reported data shows that, for the primary question the trial was examining — how many participants developed moderate-to-severe aGVHD (graded II to IV on a standard scale) — 24% of participants in the rasburicase group and 57% of participants in the control group were reported to have experienced this complication. The reported data also shows that uric acid levels in the blood (a substance the trial was tracking) were considerably lower in the rasburicase group (around 0.07–0.10 mg/dL across various measurement points) compared to the control group (ranging roughly from 1.9 to 4.2 mg/dL across the same points). Regarding unwanted medical events (called adverse events) that occurred during the trial, 21 participants in each group were reported to have experienced at least one. For one of the secondary measures — laboratory tests looking at immune responses between donor and recipient — no data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00701103 · results posted 21 March 2017
According to the results reported on ClinicalTrials.gov, this trial tested a drug called dalotuzumab in 80 people in total across 11 groups, each receiving a different dose or dosing schedule. The trial was designed to look at two main things: how the drug moved through the body over time (for example, how long it stayed in the blood and how quickly the body cleared it), and whether participants experienced serious side effects — called dose-limiting toxicities — during the first three weeks of treatment. It also measured changes in a protein called IGF-1R in skin samples, which the researchers used as a way to check whether the drug was reaching its intended target in the body. The reported data shows that across most dose groups, 0% of participants experienced a serious dose-limiting side effect during the first three weeks. In one group (the 5 mg/kg weekly dose), 13% of participants experienced such an event. For the drug's behaviour in the blood, the reported figures show that the time it took for dalotuzumab levels in the blood to halve ranged from around 67 hours in the lowest dose group up to 169 hours in one of the higher dose groups. The total amount of drug exposure in the blood (a measure of how much drug the body was exposed to overall) also increased as doses went up, ranging from 1.6 to 92.6 in the units measured. The lowest blood level of the drug before the next dose was given also rose with increasing doses, from 2.4 to 110.5 micrograms per millilitre across the groups. The rate at which the body cleared the drug from the blood was broadly similar across groups, ranging from 0.006 to 0.013 millilitres per minute per kilogram. The reported data for the skin biopsy measurements (available for only some groups and participants) shows that after receiving the drug, IGF-1R protein levels in the skin decreased in all reported groups, with the change ranging from a drop of 1.7 points in the lowest dose group to a drop of 39.0 points in the 15 mg/kg weekly group, on a scale of 0 to 300. The data was not reported for all dose groups in this secondary measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01351623 · results posted 13 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people who received a treatment called carfilzomib. The trial was measuring what is known as the "Overall Response Rate" — that is, how participants' tumours changed in size over the course of the study, based on scans (MRI and/or CT). Of the 44 who started, 35 completed the trial and 9 did not. The reported data shows the following breakdown of how participants' tumours responded, based on standard measurement criteria (called RECIST): 1 participant had a complete response (all target tumour areas disappeared on scans); 8 had a partial response (tumour areas shrank by 30% or more); 9 had stable disease (tumours neither shrank enough to count as a response nor grew enough to count as progression); 3 experienced progression of disease (tumours grew or new areas appeared); and 2 were recorded in a separate category. The reported data also shows 12 participants listed in an additional grouping, though the specific labels for each of these individual categories were not fully detailed in the submitted data. It is worth noting that some category labels in the submitted results data were not clearly matched to each number, so the full breakdown cannot be described with complete certainty from the information provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00574288 · results posted 9 March 2017
According to the results reported on ClinicalTrials.gov, this trial tested a drug called daratumumab in people with multiple myeloma (a type of blood cancer). A total of 104 participants took part across two parts of the study. In Part 1, small groups of 3 to 20 people each received different doses of the drug (less than 4 mg/kg, 4 mg/kg, 8 mg/kg, 16 mg/kg, or 24 mg/kg) to explore how it was tolerated at various dose levels. In Part 2, larger groups of 30 and 42 people received either 8 mg/kg or 16 mg/kg doses. The trial's main measurement was how many participants experienced any unwanted medical events (called adverse events) while on the drug. The reported data shows that adverse events were recorded in nearly all participants — 19 out of 20 in the lowest-dose Part 1 group, and all 3 participants in each of the other small Part 1 groups, 30 out of 30 in the Part 2 lower-dose group, and 41 out of 42 in the Part 2 higher-dose group. For a secondary measure called "overall response rate" — meaning the percentage of participants whose disease showed a defined level of improvement — the reported figures ranged widely by group: 0% in the Part 1 8 mg/kg group, 33.3% in the 4 mg/kg and 16 mg/kg Part 1 groups, 66.7% in the Part 1 24 mg/kg group, 10.0% in the Part 2 8 mg/kg group, and 35.7% in the Part 2 16 mg/kg group. The reported data also shows that in Part 2, the median time until disease progression was 2.4 months for the 8 mg/kg group and 5.6 months for the 16 mg/kg group, and that progression-free survival (the time before disease worsened or death occurred) matched those same figures. The duration of response for those who did respond was reported as 6.9 months in the Part 2 8 mg/kg group; this figure was not reported for the 16 mg/kg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02136134 · results posted 10 February 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 247 people in the bortezomib plus dexamethasone group (called "Vd") and 251 people in the daratumumab plus bortezomib and dexamethasone group (called "DVd") — 498 participants in total. The trial was measuring how long people went without their disease getting worse (called "progression-free survival"), as well as a number of other things including how long before the disease progressed, how many people had a strong response to treatment, and how long people lived overall. The reported data shows that for the primary measure — how long people went without their disease getting worse — the Vd group had a reported median of 7.16 months, while the figure for the DVd group was listed as "NA" (not available), meaning a final number was not reported for that group at the time of data submission. For the secondary measures, the reported data shows: the proportion of participants who had a "very good partial response" or better (meaning their disease markers dropped substantially) was 29.1% in the Vd group and 59.2% in the DVd group; the overall response rate (any meaningful reduction in disease markers) was 63.2% for Vd and 82.9% for DVd; the proportion with no detectable remaining disease in the bone marrow (called "MRD negativity") was 2.8% for Vd and 13.5% for DVd; and the reported median overall survival — the point by which half the participants in each group had died — was 38.51 months for Vd and 49.58 months for DVd. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02076009 · results posted 10 February 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02076009) enrolled 569 people with a type of blood cancer called multiple myeloma — 283 in one group and 286 in the other. Participants were randomly assigned to receive either a two-drug combination (lenalidomide plus low-dose dexamethasone, called "Rd") or a three-drug combination that added daratumumab to those same two drugs (called "DRd"). The trial was primarily measuring how long people went without their disease getting worse — known as "progression-free survival" — and also tracked a number of secondary measures including overall survival, response rates, and how deeply the disease responded to treatment. The reported data shows that for the primary measure — time until disease worsening or death — the Rd group had a reported median of 18.43 months, while a final median figure for the DRd group was listed as "NA" (not yet reached or not calculable at the time of reporting). For overall survival — time from the start of the trial until death — the Rd group had a reported median of approximately 51.84 months and the DRd group approximately 67.58 months. Looking at how many people responded to treatment, the reported data shows that 76.4% of the Rd group and 92.9% of the DRd group had at least a partial response. For deeper responses (called "very good partial response or better"), the figures were 44.2% for Rd and 75.8% for DRd. A measure of very deep response called "minimal residual disease negativity" was also reported across different sensitivity levels, with the DRd group consistently showing higher percentages than the Rd group across all thresholds measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01539083 · results posted 9 February 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 256 people who were being treated for a blood cancer called multiple myeloma. The study ran in two stages. First, all participants received an initial treatment combination (bortezomib, cyclophosphamide, and dexamethasone) — 203 of the 256 people who started this stage completed it. Those who responded well enough were then randomly assigned to one of two follow-up (consolidation) treatment combinations: thalidomide plus prednisolone (100 people) or bortezomib plus thalidomide plus prednisolone (103 people). The trial was primarily measuring how many participants in each group achieved a strong reduction or complete disappearance of detectable cancer markers by 12 months into the consolidation phase. The reported data shows that by month 12, 81.3% of participants in the thalidomide plus prednisolone group and 92.9% in the bortezomib plus thalidomide plus prednisolone group had reached the target response level (either a complete response or a very good partial response, meaning cancer markers were very low or undetectable). For the secondary measures, the reported data shows that the proportion achieving a complete disappearance of cancer markers grew gradually over time in both groups, reaching approximately 51% and 53% respectively by month 12. The reported median time until disease worsening or death (progression-free survival) was around 22 months in both groups. For those who achieved a complete response, the reported median time before the disease showed signs of returning was approximately 18.5 months in the thalidomide plus prednisolone group and 13.4 months in the bortezomib plus thalidomide plus prednisolone group. Overall survival figures were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00075608 · results posted 27 January 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom received a second stem cell transplant. All 12 participants completed the study, with none recorded as having dropped out. The trial was designed to look at three main things: whether the second transplant procedure was practical and manageable for participants, how well participants' bodies responded to the transplant and how long any response lasted, and how well the immune system recovered afterwards (measured by how long it took for the transplanted cells to start working in the body). The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the three primary outcome measures. This means that while the trial was completed by all 12 participants, the specific figures for tolerability, treatment response, and immune recovery were not included in the structured results data available on the registry. It is not possible to describe what those numbers were, as they were not reported there. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01239797 · results posted 5 January 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 646 people with a blood cancer called multiple myeloma who had already received at least one prior treatment. Participants were randomly assigned to one of two groups: 321 people received a three-drug combination of elotuzumab, lenalidomide, and dexamethasone, while 325 people received just lenalidomide and dexamethasone. The trial was mainly measuring how long people went without their disease getting worse (called "progression-free survival"), as well as how many people showed a measurable response to treatment. The reported data shows that, on average, people in the three-drug group went approximately 19.4 months before their disease progressed or they died, compared to approximately 14.9 months in the two-drug group. When it came to the proportion of participants whose disease showed a measurable response, the reported figures were 78.5% in the three-drug group and 65.5% in the two-drug group. For overall survival — meaning how long people lived from the start of the trial regardless of disease progression — the reported median figures were approximately 48.3 months for the three-drug group and 39.6 months for the two-drug group. The trial also tracked self-reported pain scores using a standard questionnaire (rated 0–10, where higher numbers mean more pain or interference with daily life). The reported data shows that average pain severity scores changed by +0.52 in the three-drug group and −0.04 in the two-drug group from the start to the end of treatment, and average pain interference scores changed by +0.95 and +0.48 respectively — meaning both groups reported a small increase in pain-related measures over the course of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01484314 · results posted 17 November 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01484314) enrolled only one participant. The study was looking at whether a medicine called eltrombopag could help maintain platelet counts (platelets are tiny blood cells that help with clotting) in people with relapsed multiple myeloma — a type of blood cancer — who were receiving chemotherapy. Specifically, it was measuring platelet levels and transfusion needs by the start of a third round of chemotherapy, as well as tracking any unwanted side effects and serious drops in platelet counts. The reported data shows that while one participant started and completed the study, no outcome measurement figures were submitted to ClinicalTrials.gov for any of the three outcome measures — the platelet count maintenance result, the safety and tolerability result, and the rate of serious low-platelet events. Because no numbers were provided in the submitted data, it is not possible to describe what was found for any of these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01980589 · results posted 31 October 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called carfilzomib in 22 people across three different dose levels — 3 people received the lowest dose (36 mg/m²), 3 received the middle dose (45 mg/m²), and 16 received the highest dose (56 mg/m²). All 22 participants completed the study period. The trial was primarily designed to find the highest dose that could be given without causing too many serious side effects (called "dose-limiting toxicities"), and to measure how participants' disease responded to treatment. The reported data shows that none of the participants in any of the three dose groups experienced a dose-limiting toxicity during the first 28-day treatment cycle. Regarding how the disease responded, the trial measured the percentage of people whose disease showed a meaningful reduction — across the three groups, the reported figures were 66.7% at the lowest dose, 100% at the middle dose, and 87.5% at the highest dose. The reported data also shows how quickly that response appeared: on average, it was first recorded at around 1.3 months in the lowest-dose group, 0.8 months in the middle-dose group, and 1.0 month in the highest-dose group. As for unwanted side effects of any kind, all participants across all groups had at least one adverse event recorded; more detailed breakdown figures were reported but the full category labels were not included in the submitted data, so a complete description cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00580372 · results posted 20 September 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT00580372) enrolled 231 participants, all of whom were in a single treatment group. All 231 participants who started the study also completed it, with none recorded as not completing. The trial was measuring how many people remained free of relapse (meaning no return of their condition) five years after their initial therapy. The study used a specific definition of relapse, which included things like new bone lesions, certain changes in bone marrow, or the reappearance of particular proteins in the blood or urine. The reported data shows that the primary outcome — the percentage of participants who were relapse-free at the five-year mark — was 28%. In other words, according to the reported figures, just over one in four participants had not experienced a return of their condition five years after treatment. No secondary outcome measures appear to have been included in the data submitted to ClinicalTrials.gov, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00928486 · results posted 14 June 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT00928486) enrolled 25 people who were given a combination of two medicines: lenalidomide and dexamethasone. The trial had one main thing it was measuring — how many participants experienced unwanted health events (called adverse events) after starting treatment. It also tracked two secondary things: how many participants' myeloma responded to treatment, and how long any response lasted. The reported data shows that all 25 participants experienced at least one adverse event that started after treatment began. Of those, 22 participants had adverse events rated as moderate or above in severity, and 21 had what were classified as severe events (grade 3 or higher on a standard 1–5 scale used to rank seriousness). Twelve participants experienced a life-threatening event (grade 4), and sadly 9 experienced an event rated at the highest level (grade 5, meaning death was recorded as an outcome). Seventeen participants experienced a serious adverse event — meaning one that led to hospitalisation, was life-threatening, resulted in lasting disability, or death. The reported data also shows that 24 out of 25 participants were assessed for how their myeloma responded to treatment. Of those 24, 62.5% were reported to have shown at least a partial response to treatment (meaning their myeloma markers reduced by at least half). For the third measure — how long any response lasted — the data was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01094548 · results posted 22 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people in total — 17 in each of two groups. Both groups received a treatment called tecemotide (also known as L-BLP25), but one group received a single low dose of a second drug called cyclophosphamide beforehand, while the other group received multiple low doses of cyclophosphamide. All 34 participants completed the study. The trial was primarily measuring whether the treatment triggered a specific response from the immune system — the body's natural defence system — targeting a protein called MUC-1, which is found on certain cancer cells. Participants in this trial had multiple myeloma, a type of blood cancer. The reported data shows that for the main (primary) outcome — the number of people whose immune system showed an overall response to MUC-1 — 8 out of 17 participants did so in the single-dose cyclophosphamide group, and 7 out of 17 did so in the multiple-dose group. For the secondary outcomes, the data shows that no participants (0%) in either group met the criteria for an objective clinical response, meaning no complete, partial, or minimal reductions in the cancer markers being tracked were recorded under the definitions used. The reported median time until the disease showed signs of progressing was 15.2 months in the single-dose group and 38.9 months in the multiple-dose group. The reported median time until participants needed a new anti-tumour treatment was 24.7 months in the single-dose group and 36.7 months in the multiple-dose group. Some additional breakdowns by immune system tissue type (HLA type) were also reported, but the data was presented across many subgroups with small numbers in each. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01383928 · results posted 18 December 2015
According to the results reported on ClinicalTrials.gov, this trial involved 64 people in total across three groups. Seven participants received a 3 mg dose of the drug ixazomib in Phase 1, seven received a 3.7 mg dose in Phase 1, and 50 received a 3 mg dose in Phase 2. The trial was measuring, in its first phase, what dose of ixazomib was safe enough to carry forward (called the "maximum tolerated dose" and the "recommended Phase 2 dose"), as well as tracking any unwanted medical events that occurred during treatment. The second phase used the chosen dose in a larger group of participants. The reported data shows that the highest dose at which side effects remained within the study's pre-set limits (the maximum tolerated dose) was 3.7 mg, while the dose the researchers chose to use in Phase 2 — taking into account a broader picture of side effects, nerve-related reactions, and how many people stopped treatment — was the lower 3 mg dose. In terms of unwanted medical events during Phase 1, all participants in both dose groups (100%) were reported to have experienced at least one treatment-emergent adverse event (an unintended medical occurrence that happened after starting the study drug). Serious adverse events — those resulting in hospitalisation, being life-threatening, or considered medically significant — were reported in 71% of the 3 mg group and 29% of the 3.7 mg group. Regarding nerve-related side effects, small numbers of participants in both groups experienced these at varying levels of severity, with the specific counts reported for each level. The reported data for the Phase 2 group's outcomes was not included in the submitted results data available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01568866 · results posted 11 December 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 465 people in the bortezomib plus dexamethasone group and 464 people in the carfilzomib plus dexamethasone group — a total of 929 participants with a type of blood cancer called multiple myeloma. The trial was comparing these two treatment combinations, primarily by measuring how long participants went without their disease getting worse (called "progression-free survival"). It also tracked a number of other things, including how long people lived overall, how many people showed a measurable response, how long any response lasted, and rates of certain physical changes including nerve-related symptoms and heart function. The reported data shows that the median time without disease worsening was 9.4 months in the bortezomib plus dexamethasone group and 18.7 months in the carfilzomib plus dexamethasone group. For overall survival, the reported median was 40.0 months versus 47.6 months respectively. When it came to participants showing a measurable response to treatment, the reported figures were 62.6% in the bortezomib plus dexamethasone group and 76.9% in the carfilzomib plus dexamethasone group. Among those who did respond, the median length of that response was reported as 10.4 months compared to 21.3 months. The reported data also shows that 32.0% of participants in the bortezomib plus dexamethasone group experienced moderate-to-severe nerve-related side effects (such as numbness or pain affecting daily activities), compared with 6.0% in the carfilzomib plus dexamethasone group. A significant reduction in heart pumping function was reported in 2.6% of the bortezomib plus dexamethasone group and 0.0% of the carfilzomib plus dexamethasone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01023308 · results posted 23 October 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01023308) enrolled 768 people in total — 387 received panobinostat combined with bortezomib (and dexamethasone), and 381 received a placebo combined with bortezomib (and dexamethasone). The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as how long participants lived overall, how many showed a measurable response to treatment, and how quickly that response appeared. The reported data shows that, for the main measure — time without disease progression — the panobinostat group recorded a figure of approximately 12 months (11.99 months), compared with approximately 8.8 months in the placebo group. During the study period, 207 progression events were recorded in the panobinostat group and 260 in the placebo group. For overall survival (how long participants lived), the reported figures were approximately 40.3 months in the panobinostat group and 35.8 months in the placebo group, with 134 and 152 deaths recorded in each group respectively. For overall response rate (the proportion of participants who showed a measurable response), the reported data shows 60.7% in the panobinostat group and 54.6% in the placebo group. The time until a response was first recorded was reported as approximately 1.5 months for the panobinostat group and 2.0 months for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00963820 · results posted 28 August 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT00963820) tested an investigational oral medicine called ixazomib citrate (also referred to as MLN9708) in people with multiple myeloma — a type of blood cancer. The trial had two stages: a dose-escalation phase, where researchers tested progressively higher doses to explore how the body responded, and an expansion phase, where participants were grouped by their prior treatment history. In total, 32 people took part in the dose-escalation phase across eight different dose levels, and a further 31 people took part in the expansion phase across four subgroups. The primary outcome being tracked was how many participants experienced adverse events (that is, unwanted medical occurrences after receiving the study drug) and serious adverse events (those involving hospitalisation, life-threatening situations, lasting disability, or death). The reported data shows that across every dose group and expansion subgroup, all participants who received the drug experienced at least one treatment-emergent adverse event. For example, all 3 participants at the lowest dose (0.24 mg/m²) and all 8 at the 2.97 mg/m² dose reported at least one such event, as did all 11 participants in the relapsed-and-refractory expansion group and all 10 in the VELCADE-relapsed group. The secondary outcomes tracked how the drug moved through the body — specifically, how high the drug concentration in the blood peaked and how quickly. The reported data shows that peak blood concentration generally rose with higher doses, ranging from about 3 ng/mL at the lowest dose to around 124 ng/mL at the highest dose tested. The time to reach that peak concentration was roughly 1 to 2 hours across all groups. Some drug exposure measurements (the area-under-the-curve figures for the lowest four dose groups) were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01302392 · results posted 4 August 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01302392) enrolled 315 people with a type of blood cancer called multiple myeloma — 158 were assigned to receive best supportive care (standard care without an active study drug) and 157 were assigned to receive a medicine called carfilzomib. The trial's main goal was to measure overall survival — that is, how long participants lived from the time they joined the study. The reported data shows that the median overall survival (the point at which half the participants in each group had passed away) was 10.0 months for the best supportive care group and 10.2 months for the carfilzomib group. For the secondary measures, the median time before the disease got worse or participants passed away (called progression-free survival) was reported as 3.3 months in the best supportive care group and 3.7 months in the carfilzomib group. When looking at how many participants showed a measurable reduction in disease markers, the reported data shows 18 out of 158 in the best supportive care group and 30 out of 157 in the carfilzomib group met that threshold. Among those who did show a response, how long that response lasted was reported as a median of 9.5 months in the best supportive care group and 7.2 months in the carfilzomib group. The reported data also shows that a broader measure — counting participants who showed any degree of benefit including smaller responses — captured 33 participants in the best supportive care group and 49 in the carfilzomib group. The median duration of that broader benefit was reported as 8.3 months and 6.4 months respectively. No other outcome figures beyond these were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01804140 · results posted 31 July 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01804140) enrolled 662 people who had been diagnosed with confirmed solid tumours or multiple myeloma. The main purpose of the study was to test tumour tissue samples from these participants to see how common a specific gene change — called a BRAF V600 mutation — was across different cancer types. Of the 662 people who started, 548 completed the study, and 114 did not complete it (the reasons were not detailed in the reported data). Tumour samples were sent to a central laboratory and tested using a gene-reading technique called Sanger sequencing. The reported data shows two main things that were measured. First, the percentage of participants found to carry a BRAF V600 mutation varied by cancer type: the reported figures were 0%, 3%, 11%, 0%, 0%, 3%, 6%, 2%, and 3% across the different cancer groups listed (the specific cancer type matched to each percentage was not included in the structured data provided). Second, when looking at which exact type of BRAF V600 mutation was found, the reported data shows that 16 participants carried the V600E variant, while zero participants were found to carry the V600K, V600D, or V600R variants. The reported data shows that across this group of participants, only one sub-type of the BRAF V600 mutation (V600E) was detected, and the proportion of people carrying any form of this mutation differed across the various cancer types studied. No other outcome figures were included in the data submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01324947 · results posted 30 July 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 74 participants, all of whom received the drug pomalidomide. The trial was studying people with a blood cancer called multiple myeloma, and its main goal was to measure how many participants had an "objective response" — meaning their disease showed a meaningful reduction according to recognised medical scoring systems. Of the 74 who started, 73 were included in the safety analysis and 64 were included in the main effectiveness analysis. The reported data shows that no participants were recorded as having formally "completed" the study, with all 74 listed as not completing it (which in trials of this kind often reflects the ongoing nature of the disease or its progression rather than participants simply dropping out). The reported data shows that, using one set of response criteria (IMWG), 23% of participants in the main analysis group had an objective response to treatment. Using a second, slightly different set of criteria (EBMT), the reported response rate was 20.3%. The reported data also shows that the estimated middle point for how long participants went without their disease getting worse (called progression-free survival) was 16 weeks, while the estimated middle point for time until the disease progressed was 19 weeks. For those who did respond, the estimated middle point for how long that response lasted was approximately 28.3 weeks. Regarding unwanted medical events (adverse events), the reported data shows that all 73 participants in the safety group experienced at least one adverse event, with 64 experiencing what were classed as treatment-related adverse events and 52 experiencing serious adverse events; further detail on specific event types was not broken down in the summary data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00437034 · results posted 29 July 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom received the study treatment, described as "antiangiogenesis therapy." The trial was designed to look at how often participants' blood cancer (multiple myeloma) responded to the treatment, as well as how long participants lived without their disease getting worse, how long they survived overall, and what side effects occurred. None of the 6 participants completed the study. The reported data shows that for the main measure — how many people had a response to treatment — 5 out of 6 participants were recorded under one response category, and 1 out of 6 under another. However, the results data does not specify which numbers correspond to which response categories (such as complete response or partial response), so a fuller breakdown cannot be described here. For the side effects measure, all 6 participants were reported as having data recorded, though the specific nature or severity of those side effects was not included in the submitted results. The reported data shows that the other planned measures — including how long participants went without their disease progressing, overall survival, and laboratory markers from tissue samples — had no numerical results submitted to ClinicalTrials.gov. It is worth noting that the trial was very small (only 6 participants), and the researchers themselves noted that some planned analyses could not be completed because of this small number. This means the figures above are based on a very limited group of people, and the submitted data leaves several planned outcome measures without reported numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00103506 · results posted 25 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 646 people with multiple myeloma (a type of blood cancer). Participants were split into two groups: 322 people received a medicine called Bortezomib (also known as Velcade) on its own, and 324 people received Bortezomib combined with a second medicine called Doxil/Caelyx. The trial's main goal was to measure how long it took for each person's disease to get worse — called "time to progression" — and it also tracked how long people lived overall. The reported data shows that, for the main measurement (time to progression), the middle value — meaning half of participants reached this point sooner and half later — was 6.5 months in the Bortezomib-alone group and 9.3 months in the combination group. For overall survival (how long people lived from the start of treatment), the reported middle values were 30.8 months in the Bortezomib-alone group and 33.0 months in the combination group. Regarding serious unwanted medical events (defined as those causing hospitalisation, being life-threatening, causing lasting disability, or death), the reported data shows these occurred in 105 out of 322 participants in the Bortezomib-alone group, and in 120 out of 324 participants in the combination group. No other outcome figures were reported in the submitted data. It is worth noting that the trial records show zero participants in either group were marked as having "completed" the study, and all participants were recorded under "not completed" — however, the reasons behind this classification were not explained in the data provided, so this detail is not possible to interpret further here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01049945 · results posted 30 March 2015
According to the results reported on ClinicalTrials.gov, this trial involved 70 people in total and was run in two stages. The first stage (Phase I) included 21 participants spread across five groups, each testing a different dose of a three-drug combination — bendamustine hydrochloride, lenalidomide, and dexamethasone — to find out how much of the drugs could be given before serious side effects (called "dose limiting toxicities") became too common. The second stage (Phase II) then enrolled 49 participants at the dose identified as the maximum tolerated dose (Dose Level 4), measuring how well that dose performed against multiple myeloma. The reported data shows that in Phase I, serious side effects linked to the treatment occurred rarely at most dose levels: zero events at Dose Levels 1, 3, and 4; one event at Dose Level 2; and two events at the highest dose tested, Dose Level 5. Because two such events were recorded at Dose Level 5, Dose Level 4 was identified as the maximum tolerated dose and carried forward into Phase II. In the Phase II stage, 44% of participants were reported to have achieved a confirmed response — meaning their disease showed a measurable reduction according to standard criteria. The reported data also shows results for several time-based measures in the Phase II group. The average duration of response (how long a response lasted) was reported as 24.4 months. The progression-free survival — the time before the disease worsened or a participant died — was reported as 11.8 months on average. Event-free survival, which also counted participants who moved on to a different treatment, was reported as 5.6 months. Overall survival at six months — the percentage of participants still alive at that point — was reported as 87%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00942422 · results posted 27 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 8 people, all of whom were in a single group that received a defined green tea catechin extract. The trial was measuring whether this treatment could reduce a specific protein in the blood called M-protein — a marker used to track the activity of multiple myeloma (a type of blood cancer) — by at least 25% from the participant's starting level and keep it at that lower level. Of the 8 people who started, 5 completed the trial and 3 did not. The reported data shows that the primary outcome — a sustained reduction in M-protein of 25% or more — was seen in 0% of participants. In other words, according to the reported results, none of the 8 participants achieved this level of reduction in the M-protein marker over the course of the trial. No secondary outcome data appears to have been submitted for this trial on ClinicalTrials.gov, so no further numbers can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00434161 · results posted 10 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 281 people across three groups: 109 received palifermin (a medication) only before their treatment, 115 received palifermin both before and after their treatment, and 57 received a placebo (an inactive substance). The trial was measuring mouth and throat sores — known as oral mucositis — that can develop during certain medical treatments, as well as eye lens changes (cataracts). Sore severity was rated on a scale from 0 (no problem) to 4 (unable to eat or drink anything). The reported data shows that, for the most severe mouth sore category (grade 4 — unable to take anything by mouth), 4 participants in the "palifermin before only" group, 3 in the "palifermin before and after" group, and none in the placebo group reached that level. For the primary measure of maximum sore severity, the largest number of participants across all groups fell into the mildest category (grade 0/1). Regarding how long ulcerative sores lasted, the reported data shows an average of 4.78 days for the "palifermin before only" group, 4.98 days for the placebo group, and 7.38 days for the "palifermin before and after" group. For the eye lens outcome, the reported data shows that more participants in the palifermin group (combined) showed signs of cataract development or progression compared to the placebo group across the different lens measurements at 6 and 12 months, though the specific numbers for each lens feature were not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02353468 · results posted 9 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 3 participants in a single treatment group that combined an enzyme inhibitor, a biological therapy, and chemotherapy. The trial was measuring "event-free survival" — meaning how long participants went without their condition getting worse or another significant health event occurring. A statistical method called a Kaplan-Meier curve (a way of tracking how many people remain event-free over time) was planned to analyse the results. The reported data shows that none of the 3 participants completed the trial, with all 3 listed as "not completed." Because the trial did not reach completion, no outcome measurement data was reported for the primary measure of event-free survival. In other words, the numbers needed to describe what happened over time were not submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00424047 · results posted 4 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 351 people with multiple myeloma — 176 in the lenalidomide plus dexamethasone group and 175 in the placebo plus dexamethasone group. The trial was primarily measuring how long it took for participants' cancer to start growing again (called "time to tumour progression"), and also tracked how long participants lived overall, how their myeloma responded to treatment, and what unwanted health events (adverse events) occurred during the study. The reported data shows that the median time before the disease progressed was 52.1 weeks for those in the lenalidomide plus dexamethasone group, compared with 20.1 weeks for those in the placebo plus dexamethasone group. These are the midpoint figures — meaning half the people in each group reached that point sooner, and half took longer. For overall survival (how long people lived), figures from a later data cut-off in March 2008 showed a median of 161.9 weeks in the lenalidomide group and 133.3 weeks in the placebo group; the earlier analysis did not report a calculable figure for either group. When looking at how the myeloma responded, the reported data shows that in the lenalidomide group approximately 15% of participants had a complete response (cancer markers disappearing), compared with around 4% in the placebo group. Around 44% in the lenalidomide group had a remission response (a large reduction in cancer markers), versus about 19% in the placebo group. Stable disease was recorded in roughly 3% versus 14%, and disease progression occurred in about 9% versus 6% respectively. Regarding unwanted health events, the reported data shows that all 176 participants in the lenalidomide group and all 175 in the placebo group experienced at least one adverse event of any kind. Serious adverse events — those considered life-threatening, requiring hospitalisation, or resulting in death — were reported in 137 people in the lenalidomide group and 100 in the placebo group. Events graded as life-threatening (grade 4) were reported in 46 people in the lenalidomide group and 31 in the placebo group, and deaths during the study period were recorded for 54 people in the lenalidomide group and 30 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01237054 · results posted 16 January 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people across three groups — those with MGUS (Monoclonal Gammopathy of Undetermined Significance, a condition where an abnormal protein is found in the blood but causes no symptoms), SMM (Smoldering Multiple Myeloma, an early and inactive form of blood cancer), and MM (Multiple Myeloma, an active blood cancer). Thirty participants completed the study. The trial was measuring whether different types of body scans — including two types of PET-CT scans using different tracers (18F-FDG and F18-NaF), as well as a specialised MRI scan (DCE-MRI) — could detect signs of disease across these three groups. It also looked at certain proteins in the blood and measures of blood vessel activity in bone marrow. The reported data shows that, for the FDG PET-CT scan, 0 out of 10 MGUS participants, 1 out of 10 SMM participants, and 5 out of 10 MM participants had a positive result; the remaining participants in each group returned negative results. For the NaF PET-CT scan, 0 MGUS, 0 SMM, and 9 MM participants returned positive results. For the DCE-MRI scan, 1 MGUS, 1 SMM, and 9 MM participants showed a positive pattern (early and widespread brightening of the bone marrow). Regarding blood proteins linked to blood vessel growth, the reported data shows higher average levels of markers such as Ang2, G-CSF, Follistatin, HGF, FGF-1, and VEGF-A in the combined SMM/MM group compared to the MGUS group — for example, Ang2 was reported as approximately 2,466 pg/ml in the MGUS group versus approximately 3,804 pg/ml in the SMM/MM group. Data for Endothelin 1 was not reported for either group. The reported data also shows that the average number of tiny blood vessels in bone marrow (microvessel density) was 15 per high-power field in the MGUS group, 19.4 in the SMM group, and 20.9 in the MM group. Two measures of how contrast dye moves through tissue during the MRI scan (called Kep and Ktrans — essentially measures of blood flow and leakiness in bone marrow) were also reported across the three groups, with Kep values of 3.9, 9.0, and 5.8 per minute, and Ktrans values of 2.4, 2.3, and 3.1 per minute for MGUS, SMM, and MM respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00763490 · results posted 12 January 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 adults who received a double cord blood transplant — a procedure where stem cells from two donated umbilical cords are given to a patient. All 20 participants completed the study. The trial was measuring survival rates, how well the transplanted cells took hold in the body (called "engraftment"), and rates of a complication called graft-versus-host disease (GVHD) — a condition where the donated cells react against the recipient's body. The reported data shows that 40% of participants (8 out of 20) were alive one year after their transplant. For the longer-term measure, with patients followed for up to 5 years (with a midpoint follow-up of around 2.35 years), 35% of participants were alive and free of a disease event at the end of the trial period. Regarding engraftment — whether the donated cells successfully established themselves — the reported data shows 73% of participants achieved the target neutrophil (a type of white blood cell) count within 35 days, and 89% achieved the target platelet count within that same timeframe. For the complication GVHD, the reported data shows that 40% of participants developed a moderate-to-severe form of acute GVHD within the first 100 days, and 35% developed chronic (longer-lasting) GVHD by the end of the study period. It is worth noting that because this trial had only 20 participants, these percentages represent a very small group of people, and the reported figures should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00622336 · results posted 30 December 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 330 people, all of whom received a 25 mg dose of a drug called lenalidomide. The trial was designed to track what kinds of unwanted medical events (called adverse events) the participants experienced, as well as to look at how their myeloma (a type of blood cancer) responded to the treatment and how long any response lasted. Of the 330 people who started the main treatment phase, only 21 went on to an extension phase, and none of those 21 completed the extension phase. The reported data shows that during the main treatment phase, 327 out of 330 participants experienced at least one adverse event of any kind. Of those, 268 experienced what were classed as "treatment-emergent" adverse events — meaning events that appeared or got worse after starting the drug. Breaking down the severity: 256 participants had events graded as severe or worse (Grade 3 or above), 177 had life-threatening events (Grade 4), 52 had fatal events (Grade 5), and 210 had serious adverse events as defined by the study. During the smaller extension phase (21 participants), the reported data shows 13 experienced any adverse event, 1 had a treatment-emergent event, 5 had severe events, 5 had life-threatening events, 1 had a fatal event, and 3 had serious adverse events. For the secondary outcomes — including time to progression, myeloma response rate, and duration of response — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00911859 · results posted 18 November 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00911859) enrolled 118 participants across two main parts. The smaller first part (12 people) tested a combination of three cancer medicines — bortezomib, melphalan, and prednisone (known together as VMP) — plus an additional medicine called siltuximab, mainly to check how the combination behaved in the body. The larger second part randomly assigned 54 people to receive VMP alone and 52 people to receive VMP plus siltuximab. The trial was primarily measuring how many participants achieved a "complete response" — meaning all detectable signs of the cancer protein disappeared from the blood and urine for at least six weeks, with very few abnormal cells remaining in the bone marrow. The reported data shows that in Part 2, 22.4% of participants in the VMP-alone group and 26.5% in the VMP-plus-siltuximab group were recorded as achieving a complete response. When looking at a broader measure — anyone who showed either a complete or a meaningful partial reduction in cancer markers (called "overall response") — the reported figures were 79.6% for the VMP-alone group and 87.8% for the VMP-plus-siltuximab group. A stricter version of complete response, confirmed by additional lab tests, was recorded in 6.1% of the VMP-alone group and 4.1% of the VMP-plus-siltuximab group. The reported data also shows that the time participants went without their disease getting worse or dying (called "progression-free survival") was a median of 518 days in the VMP-alone group and 519 days in the VMP-plus-siltuximab group — roughly similar between the two groups. At the one-year mark, 77.5% of the VMP-alone group and 72.1% of the VMP-plus-siltuximab group had not experienced disease progression or death. Among those who did respond to treatment, the reported median length of time their response lasted was 497 days in the VMP-alone group and 583 days in the VMP-plus-siltuximab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01063907 · results posted 5 November 2014
According to the results reported on ClinicalTrials.gov, this trial involved 95 people in total across two phases. The first phase (Phase 1) included 15 participants and was designed to find a safe and suitable dose of two drugs — KW-2478 and bortezomib — when given together. The second phase (Phase 2) enrolled 80 participants, all of whom had advanced multiple myeloma (a type of blood cancer), and was designed to measure how many people showed a response to the combination. All participants in both phases were recorded as having completed the study. The reported data shows that in Phase 2, 74 out of 80 participants were counted when measuring how people responded to treatment (the remaining 6 were not included in that particular count, though the data does not explain why). The primary goal in Phase 2 was to record the "overall response rate" — that is, the proportion of participants whose disease showed a measurable change according to pre-set criteria. The reported data also included a "disease control rate" and "progression-free survival" (the length of time before the disease was recorded as worsening), but specific numbers for these figures were not reported in the structured data submitted to ClinicalTrials.gov. The reported data also includes some Phase 1 measurements about how the drug KW-2478 moved through the body. Across the four Phase 1 dose groups, the drug was recorded as reaching its peak level in the bloodstream at roughly 1 to 1.1 hours after dosing. The peak concentration in the blood ranged from approximately 5,280 to 41,000 nanograms per millilitre depending on the dose group, and the drug's "half-life" — the time it takes for half of the drug to leave the body — was between approximately 1.77 and 2.02 hours across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00813150 · results posted 15 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 93 people in total — 46 in one group receiving bortezomib plus dexamethasone (called "Vd"), and 47 in a second group receiving bortezomib plus low-dose dexamethasone plus cyclophosphamide (called "Vcd"). The trial was measuring how long it took for the disease to get worse, how long participants lived without the disease progressing, how long participants survived overall, and what proportion of participants showed a measurable response to treatment. The reported data shows that the median time until the disease progressed — that is, the midpoint figure where half of participants had experienced worsening and half had not — was 12.6 months in the Vd group and 9.9 months in the Vcd group. The same figures were reported for progression-free survival (the time from the start of the trial until the disease worsened or a participant died). For overall survival — the time from the start of the trial until death from any cause — the reported figure for the Vd group was listed as "not available" (meaning it was not reported or could not be calculated), while the Vcd group recorded a median of 41.5 months. The reported data also shows that 74.4% of participants in the Vd group and 70.2% in the Vcd group had a measurable response to treatment according to standard criteria used for this type of blood cancer. It is worth noting that a large number of participants did not complete the treatment period in both groups (32 out of 46 in the Vd group and 32 out of 47 in the Vcd group), and very few completed the long-term follow-up phase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00578942 · results posted 23 May 2014
According to the results reported on ClinicalTrials.gov, 48 people took part in this trial, with 47 completing it and 1 person not completing it. All participants received a procedure called a "Campath purged non-myeloablative allogeneic stem cell transplant" — a type of stem cell transplant using cells from a matched related donor, prepared with a lower-intensity treatment beforehand. The trial was measuring two main things: how the body reacted to the transplant (including a complication called graft versus host disease, where donor cells can react against the recipient's body), and how long participants lived after receiving the infusion. A secondary measure looked at how many participants showed a complete response, meaning no detectable signs of their disease remained. The reported data shows that 21 participants experienced reactions consistent with acute graft versus host disease (an immune reaction where the donor cells act against the recipient's body) affecting the skin, gut, or liver within the first year. A separate figure of 25 participants was also listed under the toxicity outcome, though the data as submitted does not clearly label what each of these two numbers specifically refers to beyond the overall toxicity category. For overall survival, the reported figure was a median of 32 months — meaning that, at the midpoint of the group's survival times, participants had lived 32 months after receiving the infusion. The reported data also shows that 18 out of 48 participants met the criteria for a complete response, meaning no detectable signs of disease were found based on physical checks, blood tests, bone marrow examination, and other assessments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00075478 · results posted 19 May 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 87 people in total — 42 in one group and 45 in another. Both groups received whole-body radiation therapy (called total body irradiation, or TBI) followed by a stem cell transplant and medication to help prevent a complication called graft-versus-host disease (GVHD), where donated cells can attack the recipient's body. The key difference was that one group (Arm I) also received chemotherapy before the transplant, while the other group (Arm II) did not. The main thing the trial was measuring was how many participants were still alive at the end of the follow-up period. The reported data shows that, for overall survival, 65% of participants in the chemotherapy group (Arm I) were estimated to be surviving, compared with 54% in the group without chemotherapy (Arm II). For the secondary measurements, the reported figures for Arm I versus Arm II were: death unrelated to the disease returning (called non-relapse mortality) — 7% vs 9%; disease returning or worsening — 40% vs 55%; death following disease return — 28% vs 37%. Regarding GVHD, a moderate-to-severe acute (short-term) form was recorded in 46% of Arm I participants and 32% of Arm II participants. A longer-lasting, more extensive form of GVHD was recorded in 72% of Arm I participants and 48% of Arm II participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00507416 · results posted 1 May 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 502 people in total — 168 in one group, 167 in a second group, and 167 in a third group. All participants had a blood cancer called multiple myeloma and were not considered suitable for a stem cell transplant. The trial compared three different drug combinations: bortezomib with dexamethasone (BD), bortezomib with thalidomide and dexamethasone (BTD), and bortezomib with melphalan and prednisone (BMP). The main thing being measured was how long participants went without their disease getting worse or dying — known as "progression-free survival." The reported data shows that the median time before disease worsening or death was 14.7 months for the BD group, 15.4 months for the BTD group, and 17.3 months for the BMP group. ("Median" simply means the midpoint — half of participants in each group reached this point sooner, and half later.) For overall response — meaning participants whose disease showed at least a meaningful reduction — the reported figures were 73% for BD, 80% for BTD, and 70% for BMP. Among those who responded, the reported data shows the response lasted a median of 18.3 months (BD), 22.4 months (BTD), and 19.8 months (BMP). The reported overall survival figures — the median time from the start of the trial until death — were 49.8 months for BD, 51.5 months for BTD, and 53.1 months for BMP. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01311687 · results posted 30 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 455 people with a blood cancer called multiple myeloma — 302 were assigned to receive pomalidomide plus low-dose dexamethasone, and 153 were assigned to receive high-dose dexamethasone alone. The trial's main goal was to measure **progression-free survival** — that is, how long participants went before their disease got worse or they died during the study period. Secondary goals included tracking how long participants lived overall and recording any unwanted health events (called adverse events) that occurred during the trial. The reported data shows that, for the primary measure of progression-free survival, the pomalidomide-plus-low-dose-dexamethasone group had a median (middle value) of about 15.7–16.0 weeks before disease worsening or death, compared with about 8.0–8.1 weeks in the high-dose dexamethasone group. These figures were recorded at two different points in time, giving slightly different numbers each time. For overall survival — how long participants lived from the start of the trial — the reported data shows a median of approximately 54–56 weeks in the pomalidomide combination group and approximately 35 weeks in the high-dose dexamethasone group (measured across two later data cut-off points; the earliest analysis did not report a median figure for the pomalidomide combination group). Regarding adverse events, the reported data shows that the vast majority of participants in both groups experienced at least one unwanted health event during the trial; the specific breakdown of event types and severity grades was recorded but detailed category-by-category figures were not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00941720 · results posted 2 April 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00941720) enrolled 71 people, all of whom received a treatment called Busulfan. The trial was looking at two main things: how many participants were still alive by the end of the study period, and how many had not experienced their disease getting worse (called "relapse-free survival"). A secondary thing the trial measured was the rate of a specific side effect involving the lungs, known as pulmonary toxicity. The reported data shows that of the 71 people who started the trial, 57 completed it and 14 did not. For the two main outcomes, 53 out of 71 participants were reported as still alive at the end of the study period, and 48 out of 71 participants were reported as not having experienced their disease progressing by the end of the study period. For the secondary outcome, the reported data shows that 3.5% of participants experienced the lung-related side effect that was being tracked. No other side effect or safety data appears to have been reported in this structured results submission. It is worth noting that this trial had only one group — everyone received the same treatment — so these numbers describe what was observed in that single group, and there was no separate comparison group reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00098475 · results posted 22 January 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 452 people in total across four treatment groups. The main groups were people receiving lenalidomide with standard-dose dexamethasone (223 people) or lenalidomide with low-dose dexamethasone (222 people). A smaller expansion phase tested adding either aspirin or a blood-thinning medication called coumadin to the treatment, but this part of the trial was stopped early with only 7 people enrolled. The trial was primarily measuring what proportion of participants showed an "objective response" — meaning their myeloma (a type of blood cancer) showed clear signs of shrinking or disappearing based on specific criteria, such as a big reduction in a protein produced by cancer cells. The reported data shows that in the first treatment phase (Step 1), around 79 out of every 100 participants in the standard-dose dexamethasone group met the criteria for an objective response, while around 68 out of every 100 participants in the low-dose dexamethasone group did. For the second treatment phase (Step 2) — which was a smaller follow-on stage — the reported data shows that zero participants in either group met the objective response criteria at that point. Because the expansion arms (aspirin and coumadin groups) were closed early with very few participants, the trial's reported results focus mainly on the two main groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01251952 · results posted 16 December 2013
According to the results reported on ClinicalTrials.gov, this trial involved only 2 participants, both of whom received a treatment called Denileukin Diftitox (also known as Ontak). The trial was looking at what happens when two doses of this drug are given to people who have recently undergone an autologous stem cell transplant (a procedure where a person's own stem cells are collected and returned to them after high-dose treatment). One of the main things the trial was set up to measure was how the body responds to the drug in the hours after it is given, as well as its effects on certain immune cells and on how well the transplanted cells "engraft" (take hold and start working) in the body. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — not for the primary measure (monitoring for reactions after the drug infusion) nor for any of the four secondary measures, which looked at immune cell levels and transplant engraftment. Of the 2 participants who started the trial, 1 completed it and 1 did not. Because no measurement data was provided in the submission, it is not possible to describe any specific numbers or findings from this trial. It is worth noting that with only 2 participants enrolled, this was an extremely small trial — likely an early-stage study exploring whether and how to proceed with further research. The reported data shows the trial did not appear to reach its planned size, and the absence of reported results means no conclusions about the outcomes can be drawn from what was submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01116232 · results posted 13 December 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 4 participants, all of whom received a combination of four medications — anti-thymocyte globulin, rituximab, sirolimus, and tacrolimus. The trial was investigating these medicines in the context of bone marrow or stem cell transplantation. The study aimed to measure three main things: how often and how severely participants experienced a complication called graft-versus-host disease (where donated cells attack the recipient's body), how long it took for the donated cells to take hold in the body (called engraftment), and an overall safety assessment. Secondary goals included tracking rates of a longer-term form of the same complication, rates of certain infections, and rates of a blood vessel condition called thrombotic microangiopathy. The reported data shows that none of the 4 participants completed the trial — all 4 are recorded as "not completed." Importantly, no numerical results were submitted to ClinicalTrials.gov for any of the primary or secondary outcome measures. This means that figures for graft-versus-host disease rates, time to engraftment, safety findings, infection rates, or any other measured outcome were not reported in the data available, and it would not be appropriate to draw any conclusions about what the trial found. Because no results data was provided for any of the outcomes, the reported data shows only that the trial started with 4 participants and did not reach completion. The reasons for non-completion are not stated in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00511238 · results posted 9 December 2013
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called carfilzomib in people with a blood cancer called multiple myeloma. All participants had already been treated with at least two previous therapies, including specific drugs called bortezomib and either thalidomide or lenalidomide, and their cancer had stopped responding to the most recent treatment. The trial had two groups — a smaller earlier group (called A0, with 46 people) and a larger main group (called A1, with 266 people). The main thing the trial was measuring was the "overall response rate" — that is, the proportion of participants whose cancer showed a meaningful reduction (ranging from a partial response through to a complete response) while on the treatment. The reported data shows that in the A0 group, 16.7% of participants met the threshold for an overall response, while in the larger A1 group, 23.7% of participants did. Looking at a broader measure called "clinical benefit response" — which also included people with smaller reductions in cancer — the reported data shows 10 out of 46 people in the A0 group and 95 out of 266 people in the A1 group fell into this category. For those in the A0 group who responded, the reported data shows the response lasted a median (middle value) of around 219 days, while for those in the A1 group, the reported duration of response was around 7.8 months for the overall response group and 8.3 months for the broader clinical benefit group. For the A0 group, the reported time until the disease progressed was a median of 3.5 months; equivalent figures for the A1 group were not reported in the data provided. It is worth noting that a relatively small proportion of participants in both groups — 4 out of 46 in A0 and 40 out of 266 in A1 — were recorded as having completed the study, with the majority not completing it, though the reasons for this are not detailed in the results data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00985959 · results posted 2 December 2013
According to the results reported on ClinicalTrials.gov, a total of 99 people took part in this trial, which studied a drug called JNJ-26866138 (also known as bortezomib) used together with two other medicines, melphalan and prednisolone, in people with multiple myeloma (a type of blood cancer). The trial had two phases: a Phase I portion (18 participants) that tested three different dose levels of the drug to look at safety signals, and a Phase II portion (81 participants) that used the highest dose to look at how many participants' disease responded to treatment. The reported data shows that in Phase I, when looking for serious side effects severe enough to limit the dose (called "dose-limiting toxicities") during the first treatment cycle, zero out of 6 participants in the lowest dose group experienced one, zero out of 6 in the middle dose group experienced one, and 1 out of the participants in the highest dose group experienced one. For the question of how many participants showed a measurable response to treatment (meaning their disease showed signs of either completely disappearing or partially reducing), the reported data shows that across all groups combined, 71 out of 99 participants met the criteria for either a complete or partial response. Breaking this down, this included 6 from the lowest dose group, 5 from the middle dose group, 4 from the highest dose Phase I group, and 60 from the Phase II group at the highest dose. The reported data also includes measurements of how much of each drug was detected in participants' blood after dosing. For bortezomib given alone, peak blood levels ranged from approximately 45 to 120 nanograms per millilitre across the three dose groups, and when given in combination with the other medicines, peak levels ranged from approximately 34 to 89 nanograms per millilitre. Peak blood levels for melphalan and prednisolone were reported as approximately 100 and 1,131 nanograms per millilitre respectively, though these figures each came from a single combined group rather than being broken down by dose level. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01801436 · results posted 16 May 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT01801436) enrolled 14 participants, all of whom received the drug bortezomib. The trial was measuring how participants' disease responded to treatment at several points during their treatment cycles, by tracking changes in a blood/urine protein called M-protein (a marker associated with certain blood cancers). It also tracked participants' general ability to carry out daily activities using a scoring system called the Karnofsky Performance Status (KPS) scale, where a score of 100 means fully normal function and 0 means death. Of the 14 who started, 5 completed the trial and 9 did not. The reported data shows the following response numbers at three different time points during treatment. At the start of Cycle 5, out of the participants assessed: 1 had a complete response (full clearance of M-protein), 2 had a response (at least 75% reduction), 2 had a partial response (50–74% reduction), 1 had a minimal response (25–49% reduction), and 1 had stable disease. At the start of Cycle 7, 1 participant had a complete response, 3 had a response, and 1 had a partial response. At Day 11 of Cycle 8, 2 had a complete response, 3 had a response, 2 had a partial response, 1 had a minimal response, and 6 showed progression (worsening disease). For the KPS activity scores, the reported data shows participant numbers spread across different score levels at baseline and across treatment cycles, though the specific score labels for each measurement were not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00483262 · results posted 10 May 2013
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two drugs — CCI-779 (also called temsirolimus) and bortezomib (also called Velcade) — in people with multiple myeloma (a type of blood cancer) that had come back or stopped responding to earlier treatment. A total of 63 people took part: 20 in a smaller Phase I group (used to test dosing) and 43 in a larger Phase II group (used to look at how patients responded). The trial measured how many patients experienced side effects, how many showed a response to the treatment, and how long it was before the disease progressed or patients passed away. The reported data shows that in the Phase I group, 90% of patients experienced specific recorded toxicities (side effects or adverse reactions noted by the researchers), while in the Phase II group this figure was 79%. When it came to best response — meaning patients whose disease showed at least a partial improvement — the reported figures were 10% in the Phase I group and 33% in the Phase II group. For progression-free survival (the length of time patients went without their disease getting worse or without passing away), the reported median (middle value) was 5.7 months in the Phase I group and 5.0 months in the Phase II group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00872521 · results posted 7 May 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people in total across three groups, divided based on a genetic marker in their cancer cells called "1q21 amplification" — a change in a specific chromosome that some myeloma (a type of blood cancer) patients have. There were 26 people whose cancer cells had this marker (1q21 Amplified), 72 who did not have it (1q21 Not Amplified), and 9 whose test either failed or was missing. The trial was measuring how participants' myeloma responded to a combination treatment called PAD (made up of three medicines: bortezomib, doxorubicin, and dexamethasone), both after the treatment itself and then again three months after a stem cell transplant. The reported data shows that for the main measurement — how many people showed a meaningful reduction in their myeloma after four rounds of PAD treatment — 91 out of 107 participants were counted as responders overall. Breaking this down by group: 63 out of the 1q21 Not Amplified group, 20 out of the 1q21 Amplified group, and 8 from the failed/missing test group responded. The reported data also shows that three months after a stem cell transplant, 85 participants overall were recorded as responders (58 in the Not Amplified group, 20 in the Amplified group, and 7 in the failed/missing group). For survival figures measured two years after starting treatment, 93.8% of the Not Amplified group and 86.4% of the Amplified group were reported as still alive, while 75.0% of the Not Amplified group and 69.6% of the Amplified group were reported as free from events such as disease worsening, death, or serious complications. The "Failed/Missing Test" group was not included in the survival figures as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT00833833 · results posted 25 April 2013
According to the results reported on ClinicalTrials.gov, this trial took place in two phases and involved people with multiple myeloma (a type of blood cancer). In Phase 1, 38 participants in total were enrolled across four different dose groups of pomalidomide (2 mg, 3 mg, 4 mg, and 5 mg), to find out how much of the drug could be given before side effects became too severe. In Phase 2, 221 participants were enrolled and randomly assigned to receive either pomalidomide on its own (108 people) or pomalidomide combined with dexamethasone (113 people), to compare how long each group went without their disease getting worse. The reported data shows that in Phase 1, the number of participants who experienced a "dose-limiting toxicity" (a side effect serious enough to set an upper limit on the dose) during the first treatment cycle was: 1 out of 6 at the 2 mg dose, 1 out of 8 at 3 mg, 2 out of 14 at 4 mg, and 4 out of 10 at the 5 mg dose. For the main Phase 2 result, the reported median time until disease progression or death — known as progression-free survival — was 16.6 weeks for the pomalidomide-plus-dexamethasone group and 10.7 weeks for the pomalidomide-alone group. Regarding disease response in Phase 2, the reported data shows that 0.9% of the combination group and 0% of the pomalidomide-alone group had a complete response; 29.2% versus 9.3% had a partial response (at least a 50% reduction in a key cancer marker); and 35.4% versus 46.3% had stable disease. For side events, 100% of participants in both Phase 2 groups were reported to have experienced at least one treatment-related event of any kind, with serious adverse events reported in 88.4% of the combination group and 89.7% overall in the pomalidomide-alone group (including those who later added dexamethasone). The trial notes that data collection was ongoing at the time these results were submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00514137 · results posted 6 March 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, all of whom completed the study with no dropouts. The trial was testing a type of targeted medicine called a kinase inhibitor — a drug designed to interfere with specific proteins involved in cancer cell growth — in people with a blood cancer condition. The main thing the trial was measuring was how many participants had a confirmed reduction or disappearance of a particular abnormal protein in the blood or urine (known as an M-protein), which is used as a sign of disease response. The reported data shows that, for the primary outcome, zero out of 13 participants achieved a confirmed response — meaning none met the criteria for a complete response, a very good partial response, or a partial response as defined by the trial. For the secondary outcomes, the reported data shows that the average time participants went without their disease progressing was approximately 2.86 months. No data was reported for the duration of response outcome, so those figures are not available. Regarding side effects (referred to in the trial as "toxicity" — unwanted effects that may be related to the study drug), the reported data shows that 10 participants experienced some level of side effects possibly linked to the treatment, 3 participants experienced another level of side effects, and 0 experienced a third category; however, the specific severity levels for each of these three figures were not clearly labelled in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00560391 · results posted 20 July 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT00560391) enrolled 35 people in total across five different dose groups. All participants had multiple myeloma and were given a combination of three medicines: dasatinib, lenalidomide, and dexamethasone. The main goal of the trial was to find the right dose combination to take forward — called the "recommended Phase II dose" — by gradually increasing the doses and watching for serious side effects (called dose-limiting toxicities, or DLTs) that would signal a dose was too high. Secondary goals included looking at how participants' tumours responded to treatment. The reported data shows that the trial tested five different dose combinations, starting lower and stepping up. According to the results reported on ClinicalTrials.gov, only 2 out of 35 participants experienced a DLT — one in the lowest-dose group and one in a mid-level group — and none occurred in the highest-dose group. Because the pre-set threshold for "too many" serious side effects was never crossed at any dose level tested, the maximum tolerated dose was not formally reached. As a result, the highest dose tested — dasatinib 140 mg, lenalidomide 25 mg, and dexamethasone 40 mg — was selected as the recommended dose for any future study phase. For tumour response, the reported data shows that no participants in the three lower-dose groups achieved a complete response or a "very good partial response" (a meaningful reduction in cancer markers); 1 participant in the second-highest group and 3 in the highest-dose group did reach that level of response. The reported data also shows that across all groups, a number of participants experienced serious adverse events (unexpected medical problems serious enough to require hospitalisation or other significant action): 3 in the lowest-dose group, 2 in the second group, 0 in the third, 1 in the fourth, and 3 in the highest-dose group. Blood-related abnormalities — such as drops in white blood cell or platelet counts — were also recorded across the groups, with details varying by dose level and type of abnormality. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00405756 · results posted 11 May 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 459 people across three treatment groups. Participants were assigned to one of three combinations involving melphalan, prednisone, and lenalidomide (referred to in the data as MPR+R, MPR+p, and MPp+p), where some received lenalidomide as an ongoing "maintenance" treatment and others received a dummy pill (placebo) in its place. The trial's main goal was to measure "progression-free survival" — that is, how long participants went without their disease getting worse or dying during the study period. The reported data shows that for the primary measure of progression-free survival (calculated from the start of the trial), the MPR+R group went a median of approximately 136 weeks before disease progression or death, compared to about 62 weeks in the MPR+p group and about 56 weeks in the MPp+p group. These are estimates based on a statistical method called Kaplan-Meier, which accounts for participants who left the study early. For a secondary measure looking at progression-free survival from the start of the maintenance phase only, the reported figures were approximately 112 weeks for the MPR+R group and about 32 weeks for the MPR+p group. For overall survival (how long participants lived), the reported data shows the figures were listed as "not available" at the time of the May 2010 data cut-off, meaning those numbers had not yet been reached or were not reported at that point. The reported data also shows differences in how participants' disease responded to treatment. In the MPR+R group, 15 participants were recorded as having a complete response, 102 a partial response, and 28 stable disease. In the MPR+p group, the figures were 5, 99, and 40 respectively, and in the MPp+p group, 5, 72, and 70. The time until a first response was recorded was reported as approximately 10 weeks for MPR+R, 9.3 weeks for MPR+p, and 16.2 weeks for MPp+p. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00420849 · results posted 14 March 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 587 people, all of whom received a combination of two medicines: lenalidomide and dexamethasone. The trial was primarily focused on tracking unwanted medical events (called adverse events) that occurred after treatment began — looking at how common they were, how serious they were, and whether they appeared to be related to the treatment. A total of 256 participants completed the study, while 331 did not complete it (the reasons for this were not detailed in the data provided here). The reported data shows that out of 586 participants assessed, 519 experienced at least one treatment-emergent adverse event (that is, an unwanted medical occurrence that appeared after starting the medicine). Of those, 471 had events rated as severe or worse, and 340 had events considered life-threatening, disabling, or resulting in death. Regarding two specific areas of concern that were tracked separately: 84 participants reported nerve-related side effects (called peripheral neuropathy — things like tingling or numbness), with the first such event reported on average around 25.6 weeks after starting treatment. Separately, 60 participants reported blood clot-related events in veins, with those first appearing on average around 26.5 weeks into treatment. For quality of life, a standard questionnaire measuring physical functioning was used; the reported data shows small declines in physical functioning scores at 24 weeks across participant subgroups from Australia/Austria, the UK/Ireland, and Spain, though the details behind those individual breakdown figures were not fully reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00507442 · results posted 29 December 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 158 people in total across four different treatment groups: V-DR (42 people), VDCR (66 people), V-DC (33 people), and VDC-mod (17 people). The trial was testing different combinations of chemotherapy medicines for a blood cancer called multiple myeloma. The main thing researchers were measuring was how many patients achieved either a "complete response" (meaning no detectable cancer protein in blood or urine, and very low cancer cells in the bone marrow) or a "very good partial response" (meaning cancer protein levels dropped by 90% or more). The reported data shows that for the primary measure, the number of patients reaching either of those two best response levels was: 21 out of 42 in the V-DR group, 23 out of 66 in the VDCR group, 13 out of 33 in the V-DC group, and 9 out of 17 in the VDC-mod group. For the secondary measure of overall response (which also included partial responses), the reported numbers were 35 out of 42 (V-DR), 35 out of 66 (VDCR), 24 out of 33 (V-DC), and 17 out of 17 (VDC-mod). The reported data also shows that adverse events (unwanted side effects or medical problems) were recorded in virtually all participants — 42, 65, 33, and 17 people respectively across the four groups. The duration of response (how long responses lasted) was not reported in the submitted data. Regarding the other secondary measures, the number of patients reaching the strictest definition of complete response was small across all groups: 7, 6, 3, and 5 people respectively. Of the 158 people who started the trial, 95 were recorded as completing it, with the remaining 63 not completing it for reasons not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00478777 · results posted 3 November 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 150 people with multiple myeloma, all of whom received a combination of two medicines: lenalidomide and dexamethasone. Of those 150 participants, 144 were included in the main safety and results analysis, 73 completed the study, and 77 did not complete it. The trial was primarily measuring how long it took for participants' disease to get worse (called "time to disease progression"), and also looked at how participants' disease responded to treatment and what unwanted health events occurred during the study. The reported data shows that, on average (using a statistical method called a Kaplan-Meier estimate, which tracks time-based outcomes in a group), it took around 214 days from the start of treatment for disease progression to be first recorded. For the secondary measure looking at best overall response among the 144 participants in the main analysis group: 6 participants had a complete response (no detectable disease markers for at least six weeks), 97 had a partial response (at least a 50% drop in a key disease marker), 30 had stable disease, 3 had disease progression, and 8 had results that could not be evaluated. Combined, 103 participants had either a complete or partial response, and 133 had at least stable disease or better. Regarding unwanted health events during the study, 139 participants experienced at least one treatment-emergent adverse event (an unwanted health event that started after beginning the study medicine), and 105 experienced severe or worse events. The reported data for how long it took to reach a partial response was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00722566 · results posted 4 October 2011
According to the results reported on ClinicalTrials.gov, this trial involved 222 people with a blood cancer called multiple myeloma. Participants were split into two groups: 148 people received VELCADE (bortezomib) as a subcutaneous injection (a shot under the skin), and 74 people received VELCADE as an intravenous infusion (directly into a vein). The trial was measuring how many people in each group showed a response to treatment — meaning a reduction or disappearance of the abnormal protein that myeloma produces in the blood and urine. The reported data shows that, for the main outcome — the number of people who showed either a complete or partial response — 61 out of 148 participants in the under-the-skin injection group, and 31 out of 74 participants in the into-the-vein group, met the criteria. A "complete response" meant the abnormal protein had disappeared entirely from the blood and urine. The reported data shows that 9 people in the under-the-skin group and 6 people in the intravenous group were recorded as having a complete response. It is also worth noting that 67 people in the injection group and 35 people in the intravenous group did not complete the study, though the reasons for this were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00569868 · results posted 12 August 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 11 adults with relapsed or refractory multiple myeloma — a type of blood cancer that had either come back or stopped responding to previous treatment. All 11 participants completed the study. The trial was looking at whether treatment with Velcade (bortezomib) had any effect on the blood's clotting behaviour, since multiple myeloma can cause a state where blood clots more readily than normal. To measure this, participants underwent a series of blood-clotting tests before treatment began and again after certain doses during each treatment cycle. The reported data shows that, for the primary outcome measure — changes in blood clotting during Velcade treatment — no numerical results were submitted to ClinicalTrials.gov. The record describes how responses were intended to be categorised (for example, as complete response, partial response, no change, or worsening disease), but the actual measurement data was not reported in the registry entry. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00104104 · results posted 6 June 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 90 people in a "15-minute infusion" group and 89 people in a "30-minute infusion" group — a total of 179 participants. The trial was comparing two different infusion times for a medication called zoledronic acid, which was given by drip into a vein. The main things being measured were changes in a kidney marker in the blood (called serum creatinine — a substance that builds up when the kidneys are under stress) and whether participants' disease got worse over time. The reported data shows that, for the primary outcomes, 17 people in the 15-minute group and 13 people in the 30-minute group had a notable rise in their serum creatinine level at 12 months. Regarding disease progression (whether the disease got worse), 28 people in the 15-minute group and 20 people in the 30-minute group experienced this. For the secondary outcomes, by 24 months the number of participants with a notable rise in serum creatinine was 24 in the 15-minute group and 23 in the 30-minute group. The reported data also shows that the median time until a participant first had a significant rise in serum creatinine was about 21.6 weeks in the 15-minute group and 24.4 weeks in the 30-minute group. Drug concentration levels in the blood were also measured and were reported to be higher in the 15-minute group than the 30-minute group at the times blood was sampled. It is worth noting that relatively few participants — 15 in the 15-minute group and 17 in the 30-minute group — completed the full study period, with the majority not completing it, which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00171925 · results posted 20 April 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 143 people in total — 72 in the zoledronic acid (ZOL446) group and 71 in the control group. The trial was measuring how long participants went without their condition getting worse (called "progression-free survival"). "Getting worse" was defined as death, the disease advancing to a more serious stage, certain bone-related complications, or bone lesions (areas of bone damage) becoming noticeably larger. Of those who started the trial, 42 people in the zoledronic acid group and 40 in the control group completed it. The reported data shows that, on average, participants in the zoledronic acid group went approximately 1,078 days without progression, compared to approximately 993 days in the control group. Looking at secondary outcomes — meaning additional things the trial tracked — the reported data shows that 19 out of 72 participants in the zoledronic acid group experienced overall disease progression, compared to 26 out of 71 in the control group. Regarding bone-related complications specifically, the reported data shows that none of the 72 participants in the zoledronic acid group experienced any of the tracked bone complications (such as fractures, spinal cord issues, or high calcium levels), while small numbers in the control group did — for example, 4 participants in the control group experienced pathologic fractures (bones breaking without significant injury), and 1 experienced spinal cord compression. It is worth noting that a meaningful number of participants did not complete the trial in either group (30 in the zoledronic acid group and 31 in the control group), and the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00259740 · results posted 6 January 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 96 people across two groups: 43 participants whose multiple myeloma (a type of blood cancer) was in a stable, "plateau" phase, and 53 participants whose disease had relapsed (come back). The trial was measuring whether a medicine called denosumab, given every four weeks, had any effect on a protein in the blood called M-protein — a marker that doctors use to track multiple myeloma activity. Reductions in this protein were used to define different levels of response: a "complete response" (the protein becoming undetectable), a "partial response" (at least a 50% drop), and a "minimal response" (a 25–49% drop), each needing to last at least six weeks. The reported data shows that, for the primary outcome — the number of participants achieving either a complete or partial response based on M-protein levels — the result was zero participants in both groups. The secondary outcomes told the same story: when also counting minimal responses, and when looking at complete responses alone, the reported number of participants meeting those criteria was again zero in both groups. It is also worth noting that, according to the reported data, none of the participants were recorded as having "completed" the study, and all participants in both groups were listed under "not completed," though the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00608517 · results posted 10 November 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 6 participants across three groups: 2 children receiving a more intensive pre-transplant treatment (called "myeloablative conditioning"), 3 adults receiving the same intensive pre-transplant treatment, and 1 adult receiving a less intensive version (called "reduced-intensity conditioning"). The trial was looking at whether umbilical cord blood stem cell transplants were feasible and what happened to participants in the 100 days after the transplant, including death from causes other than the original illness returning, as well as longer-term outcomes such as survival at one year. One child did not complete the study; all adult participants did. The reported data shows the following numbers across the three groups. For the primary measure — deaths within 100 days from causes other than the disease coming back — 1 participant was recorded in the children's intensive group, and 0 in each of the two adult groups. For the secondary measures: donor cells were successfully established (engraftment) in 1 participant in the children's group and 1 in the adult intensive group; data for the reduced-intensity group was not reported for this measure. A complication where donor cells attack the recipient's body (called "graft-versus-host disease") was recorded in 0 children, 1 adult in the intensive group, and 0 in the reduced-intensity group. No relapses at one year were recorded in any group. One participant in the children's group was recorded as having died from any cause within 100 days. For survival at one year, the reported data shows 1 participant in the children's group, 3 in the adult intensive group, and 1 in the reduced-intensity group. It is worth noting that with only 6 participants in total, this was a very small trial, and the reported numbers reflect only the individuals who took part. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00531453 · results posted 4 June 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 98 people in total — 49 in each of two groups. All 98 participants completed the study. The trial was comparing two treatment regimens for a blood-related condition: one group received a three-drug combination (referred to as VDT) and the other received a four-drug combination (referred to as VDTC). The trial was measuring how many participants reached what researchers called a "complete response" — meaning no detectable signs of disease in blood, urine, or bone marrow — at two different points: after an initial treatment phase (called induction), and then again after a more intensive treatment involving high-dose chemotherapy followed by a stem cell transplant. The reported data shows that after the initial induction treatment phase, 51% of participants in the three-drug group and 44% of participants in the four-drug group met the criteria for a combined complete response. After the subsequent high-dose chemotherapy and stem cell transplant phase, the reported figures were higher in both groups — 76% in the three-drug group and 78% in the four-drug group reached that combined complete response level. These percentages represent only the participants in this specific trial and simply reflect how many people met the defined response criteria at each measurement point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00056160 · results posted 3 March 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 353 people with multiple myeloma (a type of blood cancer affecting plasma cells). Participants were randomly assigned to receive either a combination of CC-5013 (lenalidomide) with dexamethasone (177 people) or a placebo with dexamethasone (176 people). The trial was primarily measuring how long it took for the disease to get worse, and also tracked overall survival, how many people showed a measurable response in their myeloma, and how long it took for participants' general physical functioning to decline. The reported data shows that, for the main measure — time until the disease progressed — the CC-5013/dexamethasone group had a reported median (middle value) of 60.1 weeks, compared to 20.1 weeks in the placebo/dexamethasone group. For overall survival — meaning time from entering the trial until death from any cause — the reported figures were 170.1 weeks for the CC-5013/dexamethasone group and 136.4 weeks for the placebo/dexamethasone group. The reported data shows that 107 out of 177 participants in the CC-5013/dexamethasone group showed a measurable myeloma response, compared to 34 out of 176 in the placebo/dexamethasone group. For the measure of physical functioning decline, the reported median time before a worsening was noted was 29.9 weeks in the CC-5013/dexamethasone group and 15.0 weeks in the placebo/dexamethasone group. It is worth noting that far fewer participants completed the blinded phase of the trial in the placebo/dexamethasone group (13 people) compared to the CC-5013/dexamethasone group (64 people), and the trial continued with an extended follow-up period for the CC-5013/dexamethasone group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00229203 · results posted 14 December 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people with multiple myeloma (a type of blood cancer) — 32 in a group receiving a medicine called plitidepsin on its own, and 19 in a group receiving plitidepsin combined with dexamethasone (a steroid). The trial was measuring how many participants showed a reduction in their cancer markers in blood or urine, and how long it took for the disease to get worse. The reported data shows that none of the 51 participants were recorded as having "completed" the study in the formal sense, meaning all participants exited the trial early for various reasons (the specific reasons were not broken down in the data provided). The reported data shows that for the main measure — the rate of patients showing any meaningful reduction in cancer protein levels (combining complete, partial, and minimal responses) — the figure was 10% in the plitidepsin-only group and 22% in the plitidepsin-plus-dexamethasone group. Looking at disease stability, 41% of the plitidepsin-only group and 61% of the combination group had stable disease, while 48% and 17% respectively were recorded as having their disease progress. For two secondary measures — the time until the disease got worse — the plitidepsin-only group had a reported figure of 2.3 months, compared to 4.2 months (time to progression) and 3.8 months (progression-free survival) in the combination group. Regarding survival at two recorded time points, 70% and then 53% of the plitidepsin-only group were reported as alive, compared to 76% and then 61% of the combination group, though the specific time points for these figures were not clearly stated in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.