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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)
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05519085.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center