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)

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full 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 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 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.

About the study

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.

What is being tested

BMS-986393 (drug)
Cyclophosphamide (drug)
Fludarabine (drug)
Daratumumab (drug)
Pomalidomide (drug)
Dexamethasone (drug)

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Participants: 440 · Started: Mar 12, 2025

Contact the study team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286

Official record on ClinicalTrials.gov — NCT06615479

Locations in the U.S.

Alabama	University of Alabama at Birmingham, Birmingham
California	UCLA Hematology/Oncology - Santa Monica, Los Angeles University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange
District of Columbia	Georgetown University Medical Center, Washington D.C.
Florida	Baptist MD Anderson Cancer Center, Jacksonville University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami
Georgia	Winship Cancer Institute, Emory University, Atlanta
Louisiana	Louisiana State University Health Sciences Shreveport, Shreveport
Massachusetts	Boston Medical Center, Boston
New York	Weill Cornell Medical College, New York
North Carolina	Levine Cancer Institute, Charlotte Levine Cancer Institute, Charlotte
Ohio	Cleveland Clinic, Cleveland
Pennsylvania	AHN West Penn Hospital, Pittsburgh
Texas	University of Texas MD Anderson Cancer Center, Houston
Utah	Huntsman Cancer Institute, Salt Lake City
Wisconsin	Medical College of Wisconsin, Milwaukee

Conditions

Multiple Myeloma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.