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Recruiting

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) - CA057-001

Opdateret: 18 juni, 2024   |   ClinicalTrials.gov

Celgene er et helejet datterselskab af Bristol-Myers Squibb 

Udskriftsvenligt sammendrag

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Forsøgsdetaljer

  • Phase 3

    Fase

  • Køn

  • 18+

    Aldersinterval

  • 92

    Beliggenhed(er)

  • Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: 480Vd (CC-92480, bortezomib and dexamethasone)
Experimental: PVd (pomalidomide, bortezomib and dexamethasone)

Primære egnethedskriterier

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.

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