Trial 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
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.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Myeloma Trial, Active, Not Recruiting
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are 18 years of age or older at the time of signing the consent form
- You have been diagnosed with Multiple Myeloma (a type of blood cancer) confirmed by a lab test
- You have already received at least 3 different treatment regimens for your myeloma, including one from each of these three drug types: an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 antibody (confirm specific drug names with trial site)
- If you have had a stem cell transplant using your own cells, it must have been more than 100 days ago and you must have no active infections
- You are generally able to carry out basic daily activities (a doctor will assess this using a standard scale), or if your activity level is more limited, it is only because of bone-related pain or complications from your myeloma
- Your myeloma can be measured through specific blood or urine tests showing certain protein levels above set amounts (confirm exact levels with trial site)
- If you have tested positive for a Hepatitis B antibody, you may still be eligible if your Hepatitis B surface antigen is negative and the virus is undetectable in your blood during screening
- You are currently taking only low-dose oral steroids (less than 10mg per day), inhaled steroids, or eye drop steroids
Who may not be able to join:
- You have a current eye surface condition, except for a very mild form (confirm with trial site)
- You have signs or evidence of heart or cardiovascular risk (confirm with trial site)
- You have had a serious allergic reaction to the study drug (belantamab mafodotin) or similar drugs, or to other monoclonal antibody treatments
- You currently have an active infection being treated with antibiotics, antiviral, or antifungal medicines
- You have received certain antibody treatments within the last 30 days, or other myeloma treatments within the last 14 days
- You have had radiotherapy within the 2 weeks before starting the study
- You have previously had a stem cell transplant using cells from another person (allogeneic transplant)
- You have received a type of immune cell therapy called CAR-T therapy with chemotherapy-based preparation within the last 3 months
- You have had major surgery (other than bone-stabilising surgery) within the last 30 days
- You have received an experimental treatment within the last 14 days, or within 5 half-lives of the drug, whichever is sooner (confirm with trial site)
- You had a serious (grade 3 or higher) side effect from a previous type of cancer treatment called a checkpoint inhibitor that caused you to stop that treatment
- You have received a blood transfusion within the 2 weeks before the first study dose
- You have received a live vaccine within 30 days before starting the study, or plan to receive one during or for at least 70 days after the study treatment
- You have an active kidney condition such as an infection or need for dialysis (isolated kidney-related protein from myeloma itself may still be acceptable — confirm with trial site)
- You have HIV, unless you meet specific conditions including being on stable HIV treatment, having a low viral load, and having a strong enough immune system with no serious HIV-related infections in the past year (confirm full details with trial site)
- You have a known severe allergy to the drug Isatuximab or any of its ingredients
- You have received a different anti-CD38 antibody treatment within 6 months before your first study dose
- You have a known intolerance or allergy to certain ingredients including infused proteins, sucrose, histidine, or polysorbate 80
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLT); DE Phase: Number of Participants With Adverse Events (AEs); DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline; DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline; Cohort Expansion (CE) Phase: Overall Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.