A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Registration Number
- NCT05519085
- Lead Sponsor
- Celgene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 810
Inclusion Criteria<br><br> - Participant has documented diagnosis of MM and measurable disease, defined as any of<br> the following:.<br><br>i) M-protein = 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.<br><br>ii) M-protein = 200 milligrams (mg) per 24-hour urine collection by urine protein<br>electrophoresis (uPEP).<br><br>iii) For participants without measurable disease in sPEP or uPEP: serum free light chain<br>(sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC<br>ratio.<br><br> - Participants received 1 to 3 prior lines of antimyeloma therapy.<br><br> - Participants achieved minimal response [MR] or better to at least 1 prior<br> antimyeloma therapy.<br><br>Exclusion Criteria<br><br> - Participant has had progression during treatment or within 60 days of the last dose<br> of a proteasome inhibitor, except as noted below:.<br><br> i) Subjects who progressed while being treated with, or within 60 days of last dose<br> of bortezomib maintenance given once every 2 weeks or less are not excluded.<br><br> - For participants with prior treatment of a bortezomib containing regimen, the best<br> response achieved was not a minimal response (MR) or better, or participant<br> discontinued bortezomib due to toxicity.<br><br> - Participant has had prior treatment with mezigdomide or pomalidomide.<br><br> - Other protocol-defined Inclusion/Exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS)
- Secondary Outcome Measures
Name Time Method Recommended mezigdomide dose;Plasma concentrations of mezigdomide;Overall Survival (OS);Overall Response (OR);Complete Response (CR) or better;Very Good Partial Response (VGPR) or better;Time to Response (TTR);Duration of Response (DOR);Time to Progression (TTP);Time to Next Treatment (TTNT);Progression-free Survival 2 (PFS-2);Minimal Residual Disease (MRD) negativity;Number of participants with Adverse Events (AEs);Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores;Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score