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)

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Sponsor score: 0

ClinicalTrials ID:NCT06615479

This clinical trial evaluates the efficacy and safety of BMS-986393 compared to standard regimens in adults with relapsed or refractory, lenalidomide-refractory multiple myeloma. Participants receive specified doses of BMS-986393 or standard drugs like Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, and Carfilzomib. Eligibility criteria focus on adults with specific myeloma conditions.

Patient Parameters

Program 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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Local Institution - 007135205BirminghamAlabama
UCLA Hematology/Oncology - Santa Monica90404Los AngelesCalifornia
Local Institution - 013033136MiamiFlorida
Winship Cancer Institute, Emory University30322AtlantaGeorgia
Local Institution - 013321218BaltimoreMaryland
Local Institution - 013127710DurhamNorth Carolina
Local Institution - 019344195ClevelandOhio
Local Institution - 009719111PhiladelphiaPennsylvania
Local Institution - 004484112Salt Lake CityUtah
Local Institution - 006853792MadisonWisconsin

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