A Study to Evaluate CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

• Status: Not yet recruiting
• Trial end date: 2030-01-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Bortezomib; Dexamethasone; Pomalidomide

Criteria

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.