This study aims to compare ixazomib plus dexamethasone versus pomalidomide plus dexamethasoneon survival in participants with relapse and/or refractory multiple myeloma. The outcome to be measured is the duration of time until disease progresses (worsens).
The details
Multiple myeloma is a cancer of the plasma cells in the blood. Treatment for multiple myeloma includes chemotherapy. Following treatment, many patients are refractory (do not respond to treatment) or relapse (have return of cancer). Ixazomib (Ninlaro) is a drug approved for treatment in patients who have received at least one prior therapy. Pomalidomide (Imnovid) and dexamethasone is a treatment combination for patients with relapsed and/or refractory multiple myeloma.
This study aims to compare ixazomib and pomalidomide in combination with dexamethasone. The main outcome will be measured by the time it takes for the disease to progress following treatment.
Who are they looking for?
This study is recruiting 300 participants with relapsed and/or refractory multiple myeloma. Participants should have received at least 2 prior lines of treatment. Participants should have previously received lenalidomide but not responded to it. Participants should also have previously received a proteasome inhibitor such as bortezomib or carfilzomib but had responded to it. Participants should not have smoldering multiple myeloma, Waldenström's macroglobulinemia, primary amyloidosis, or myelodysplastic syndrome. Participants should not have multiple myeloma that has affected the central nervous system. Participants should not have any gastrointestinal disease or active infection.
How will it work
Participants will be randomly assigned to one of 2 treatment groups. Participants in the first treatment group will receive ixazomib plus dexamethasone. Participants in the second treatment group will receive pomalidomide plus dexamethasone. Participants will receive the treatment in cycles of 28 days until disease progresses, or there are unacceptable side effects or participants decides to withdraw. Participants will be followed-up for up to 63 months, during which blood and urine tests will be taken.
