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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)

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05519085
Protocol IDs
CA057-001 (primary)
NCI-2023-04557
2021-001957-30
2023-509859-13
Study Sponsor
Celgene

Summary

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

  1. 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.
  2. Participants received 1 to 3 prior lines of antimyeloma therapy.
  3. Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.

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