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Trial ID CA088-1007  |   NCT06615479

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)

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 57
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must have relapsed or refractory multiple myeloma (RRMM).
    1. 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).
      1. Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
        1. Participants must have measurable disease during screening.
          1. Participants must have adequate organ function.
            1. Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.

              Exclusion Criteria

              Exclusion Criteria Icon
              • Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
                1. Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
                  1. Participants must not need urgent treatment due to rapidly progressing MM.
                    Additional Information *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: Arm A

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986393, Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, Carfilzomib

                      Study Arms

                      Active Comparator: Arm B

                      ASSIGNED INTERVENTION
                      • Drug: Daratumumab, Pomalidomide, Dexamethasone, Carfilzomib
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