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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 (SUCCESSOR-2)

CODICE STUDIO

NCT05552976

TIPOLOGIA

Ricaduti

NOME SPONSOR

Bristol-Myers Squibb

DESCRIZIONE

Trattamento

Experimental: 480Kd (CC-92480 + Carfilzomib + Dexamethasone)

  • Drug: CC-92480Specified dose on specified daysOther Names:
    • BMS-986348
    • Mezigdomide
  • Drug: CarfilzomibSpecified dose on specified daysOther Name: Kyprolis
  • Drug: DexamethasoneSpecified dose on specified daysOther Names:
    • Decadron
    • Dex

Active Comparator: Kd (Carfilzomib + Dexamethasone)

  • Drug: CarfilzomibSpecified dose on specified daysOther Name: Kyprolis
  • Drug: DexamethasoneSpecified dose on specified daysOther Names:
    • Decadron
    • Dex

Obiettivo principale

Progression-free Survival (PFS) [ Time Frame: Up to approximately 5 years ]

Criteri di inclusione

  • 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 at least 2 cycles of 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.

Criteri di esclusione

  • 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.

FARMACI UTILIZZATI

Carfilzomib, Desametasone, CC-92480 ( Mezigdomide)