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Trial ID CA057-001  |   NCT05519085

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 117
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.
    1. M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.
      1. M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).
        1. 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.
          1. Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.

            Exclusion Criteria

            Exclusion Criteria Icon
            • Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.
              1. 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.
                1. Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment 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.
                  1. Participant has had prior treatment with mezigdomide or pomalidomide.
                    Additional Information *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: MeziVd (mezigdomide, bortezomib and dexamethasone)

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: PVd (pomalidomide, bortezomib and dexamethasone)

                      ASSIGNED INTERVENTION
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