A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) (Successor-1)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2033
  • participants needed
    760
  • sponsor
    Bristol-Myers Squibb
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Updated on 25 October 2022
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Summary

The purpose of this study is to compare the efficacy and safety of CC-92480, bortezomib and dexamethasone (480Vd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Details
Condition Relapsed or Refractory Multiple Myeloma
Treatment Pomalidomide, Dexamethasone, Bortezomib, CC-92480
Clinical Study IdentifierNCT05519085
SponsorBristol-Myers Squibb
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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