A Phase 2, Single Arm Multicenter, Study Testing Mezigdomide, Carfilzomib, and Dexamethasone (480Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Sponsor: Assistance Publique - Hôpitaux de Paris + Bristol-Myers Squibb
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Determine the progression-free survival (PFS) of mezigdomide, carfilzomib and dexamethasone (480Kd) in participants with relapsed or refractory multiple myeloma (RRMM)
Time frame: 2 years
Secondary Endpoints
Overall Survival (OS)
Best overall Response Rate (ORR)
Rate of very good partial response (VGPR) or better (VGPRR)
Eligibility Criteria
Inclusion Criteria: 1. Signed Written Informed Consent 2. Adult patients (≥18 years old) 3. ECOG Performance Status score of 0, 1, or 2. 4. Participant has documented diagnosis of multiple myeloma (MM) and measurable disease, defined as any of the following: 1. M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or 2. M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or, 3. For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal κ/λ FLC ratio. 5. Participant has received one or two prior line of anti-myeloma therapy. Note: One line can contain several phases (eg, induction, \[with or without\] hematopoietic stem cell transplant, (with or without) consolidation, and/or \[with or without\] maintenance therapy). 6. Participant must have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody. 7. Participant ach…
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