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

Recruiting
18 years of age
Both
Phase 3

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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.

Eligibility

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 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.

Study details

Relapsed or Refractory Multiple Myeloma

NCT05519085

Celgene

23 June 2024

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