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Szukaj Study Connect

Recruiting

A Study to Evaluate CC-92480 in Combination With Carfilzomib and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma - CA057-008

Zaktualizowano: 10 kwiecień, 2024   |   ClinicalTrials.gov

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Szczegóły badania

  • Phase 3

    Etap

  • Płeć

  • 18+

    Zakres wieku

  • 78

    Lokalizacje

  • Recruiting

Opcje leczenia

Grupy badania
PRZYPISANA INTERWENCJA
Experimental: 480Kd (CC-92480 + Carfilzomib + Dexamethasone)
Drug: CC-92480, Dexamethasone, Carfilzomib
Active Comparator: Kd (Carfilzomib + Dexamethasone)
Drug: Dexamethasone, Carfilzomib

Kluczowe kryteria kwalifikacyjne

Inclusion Criteria: - Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following: - Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or - M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or, - For participants without measurable disease in sPEP or uPEP: serum free light chain levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio . - Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy). - Participant must have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody. - Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy. - Participant must have documented disease progression during or after their last antimyeloma regimen. Exclusion Criteria: - Participant who has had prior treatment with CC-92480 or carfilzomib. - Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment. Additional protocol-defined criteria apply.