The purpose of this study is to compare the efficacy and safety of CC-92480, bortezomib and dexamethasone (480Vd) 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.

Basic information

Official Title: A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
Trial ID: NCT05519085
Status: Recruiting
Last Known Status: Not Available from clinicaltrials.gov

Trial Phase: Phase 3

Keywords: Multiple myeloma, RRMM, 480Vd, PVd, CC92480, pomalidomide, bortezomib, dexamethasone, mezigdomide

Subjects

Age (Minimum Eligibility): 18 Years
Age (Maximum Eligibility):
Gender: All
Healthy Subject(s): No

Inclusion Criteria:

Participant has documented diagnosis of MM and measurable disease, defined as any of the following:

M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP) 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. 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 CC-92480 or pomalidomide.

Other protocol-defined criteria apply.