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  • NCT06615479

Not Yet Recruiting

A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2) - CA088-1007

Opdateret: 20 november, 2024   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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VÆLG SPROG

Forsøgsdetaljer

  • Phase 3

    Fase

  • Køn

  • 18+

    Aldersinterval

  • 53

    Beliggenhed(er)

  • Not Yet Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Arm A
Drug: BMS-986393, Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, Carfilzomib
Active Comparator: Arm B
Drug: Daratumumab, Pomalidomide, Dexamethasone, Carfilzomib

Primære egnethedskriterier

Inclusion Criteria - Participants must have relapsed or refractory multiple myeloma (RRMM). - Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody, and be refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy). - Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria. - Participants must have measurable disease during screening. - Participants must have adequate organ function. - Participants must have an Eastern Cooperative Oncology group performance status 0 or 1. Exclusion Criteria - Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM). - Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease. - Participants must not need urgent treatment due to rapidly progressing MM. - Other protocol-defined Inclusion/Exclusion criteria apply.

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