Phase 3 Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (SUCCESSOR-1)
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM)
- Registration Number
- JPRN-jRCT2071230097
- Lead Sponsor
- ishio Mitsufumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
1. Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:
a. M-protein >= 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or
b. M-protein >=200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP)
c. 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 kappa/lambda FLC ratio.
2. Participants received 1 to 3 prior lines of antimyeloma therapy.
3. Subject must have received prior treatment with a lenalidomide-containing regimen.
4. Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.
1. Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:
a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded.
2. For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
3. Participant has had prior treatment with mezigdomide or pomalidomide.
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 Overall Survival (OS),Overall Response (OR),Complete Response (CR) or better,Very Good Partial<br>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,Safety,Health Related Quality of Life (HRQoL) Evaluation