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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)

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 and older
All
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 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.

Study details
    Relapsed or Refractory Multiple Myeloma

NCT05519085

Celgene

14 August 2025

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