What's the purpose of this trial?
The goal of this clinical trial is to learn more about the safety and effectiveness of investigational drug Mezigdomide when combined with approved treatments carfilzomib and dexamethasone compared to approved treatments carfilzomib and dexamethasone alone in participants with relapsed and refractory multiple myeloma.
This trial is currently open and accepting patients.
What will happen during the trial?
This study is being conducted in two different parts, or stages.
STAGE 1
In Stage 1, there are four planned groups, also called arms. Three of the four arms will receive different dose levels of investigational drug mezigdomide in combination with approved treatments carfilzomib and dexamethasone, and one arm will receive approved treatments carfilzomib and dexamethasone.
STAGE 2
In Stage 2, there are two planned arms. One arm will receive mezigdomide (at the selected dose determined by stage 1), Carfilzomib and Dexamethasone, and the other arm will receive Carfilzomib and Dexamethasone.
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
- have measurable disease according to the trial criteria.
- have received at least one prior line of therapy, including lenalidomide and an anti-CD38 monoclonal antibody (for instance, daratumumab or isatuximab)
- have not previously received investigational drug mezigdomide or Carfilzomib.
- have not previously received an allogeneic stem cell transplant, and have not had an autologous stem cell transplant in the three months before joining the study.
- have adequate bone marrow and kidney function as described in the trial criteria.
Additional eligibility criteria apply and can be explained by the study doctor.
Additional Trial Information
Phase 3
Enrollment: 525 patients (estimated)
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