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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) (SUCCESSOR-1)

CODICE STUDIO

NCT05519085

TIPOLOGIA

Ricaduti

NOME SPONSOR

Bristol-Myers Squibb

DESCRIZIONE

Trattamento

Experimental 480Vd (CC-92480, bortezomib and dexamethasone):

CC-92480

  • Specified dose on specified days
  • Other Names:
    • BMS-986348
    • Mezigdomide

Bortezomib

  • Specified dose on specified days
  • Other Names:
    • Velcade
    • BTZ

Dexamethasone

  • Specified dose on specified days
  • Other Names:
    • Decadron
    • Dex

Experimental: PVd (pomalidomide, bortezomib and dexamethasone):
Pomalidomide

  • Specified dose on specified days
  • Other Names:
    • Pomalyst
    • Imnovid
    • Pom

Bortezomib

  • Specified dose on specified days
  • Other Names:
    • Velcade
    • BTZ

Dexamethasone

  • Specified dose on specified days
  • Other Names:
    • Decadron
    • Dex

Obiettivo Principale

Progression-free Survival (PFS) [ Time Frame: From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years) ]

Criteri di inclusione

  • 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.

    Criteri di esclusione

    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.

FARMACI UTILIZZATI

Bortezomib (velcade), Pomalidomide, Desametasone, CC-92480 ( Mezigdomide)