Study Comparing Mezigdomide, Bortezomib, and Dexamethasone (MEZIVd) to Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Patients with Relapsed or Refractory Multiple Myeloma
Sponsor: Celgene
ClinicalTrials ID:NCT05519085
This clinical trial is testing two different treatment combinations to see which is more effective and safe for patients with multiple myeloma that has returned or not responded to previous treatments. Participants must have tried 1 to 3 other treatments before and have been treated with lenalidomide.
Patient Parameters
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Program Overview
The goal of this study is to compare two treatment combinations for patients with multiple myeloma that has come back or not responded to previous treatments. The study will look at how well the treatments work and how safe they are. One group will receive mezigdomide, bortezomib, and dexamethasone (MeziVd), while the other group will receive pomalidomide, bortezomib, and dexamethasone (PVd). Participants should have tried 1 to 3 other treatments before and must have been treated with lenalidomide.
Eligibility Criteria
Inclusion Criteria
- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.
i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.
ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).
iii) 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.
- Participants received 1 to 3 prior lines of antimyeloma therapy.
- Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.
Exclusion Criteria
- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.
i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.
ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.
- 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.
- Participant has had prior treatment with mezigdomide or pomalidomide.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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