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 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.
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 3 Myeloma Trial, Completed
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 must be 18 years old or older.
- You must be well enough to carry out basic daily activities, with only mild limitations at most (confirm with trial site for exact fitness level required).
- Your doctor expects you to live for at least 3 more months.
- You have already been diagnosed with multiple myeloma.
- Your multiple myeloma has come back, or come back and stopped responding to treatment, after receiving at least 3 but no more than 6 previous treatment plans, including initial treatment and stem cell transplant if you had one (which counts as just one treatment plan).
- You must have previously been treated with regimens that included the drugs bortezomib and lenalidomide (or thalidomide if lenalidomide was not available to you).
- If you are a woman who could become pregnant, you must have a negative blood pregnancy test before joining.
- You must be willing to sign and date a consent form agreeing to take part in the trial.
Who may not be able to join:
- You have certain other serious illnesses or health conditions at the same time (confirm with trial site for specific conditions).
- You are currently pregnant or breastfeeding.
- You are currently taking corticosteroids, chemotherapy, or any other treatment that may be working against your multiple myeloma.
- You have had a known allergic reaction to any of the drugs used in this trial or their ingredients.
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
Principal Investigator: Óscar F. Ballester, M.D., Edwards Comprehensive Cancer Center, Marshall University (Huntington)
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
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression Free Survival (PFS) as Per Intention-to-treat (ITT); Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months
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.