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

a study on Multiple Myeloma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.

Official Title

A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma

Keywords

Relapsed or Refractory Multiple Myeloma (RRMM), Relapsed or Refractory Multiple Myeloma, Multiple Myeloma, BMS-986393, Chimeric Antigen Receptor T-cell (CAR T-cell), CAR T-cell Therapy, Arlocabtagene Autoleucel, Arlo-cel, Recurrence, Cyclophosphamide, fludarabine, daratumumab, pomalidomide, Dexamethasone, carfilzomib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 have prior exposure to lenalidomide.
  • 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

You CAN'T join if...

  • 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

  • UCLA Hematology/Oncology - Santa Monica accepting new patients
    Los Angeles 5368361 California 5332921 90404 United States
  • Local Institution - 0044 not yet accepting patients
    Salt Lake City 5780993 Utah 5549030 84112 United States
  • Vancouver General Hospital accepting new patients
    Vancouver 6173331 British Columbia 5909050 V5Z 1M9 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06615479
Phase
Phase 3 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 440 study participants
Last Updated