
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:
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- 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.
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Other protocol-defined criteria apply.
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FARMACI UTILIZZATI