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Clinical Trials in the USA / NCT06615479
Recruiting Phase 3

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)

NCT06615479 · tracked via the Priya Life Science USA tracker
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Phase
Phase 3
Started
2025-03-12
Last updated
2026-09-15

Condition(s) studied

Relapsed or Refractory Multiple Myeloma (RRMM)

Investigational drug(s) / intervention(s)

BMS-986393CyclophosphamideFludarabineDaratumumabPomalidomideDexamethasoneCarfilzomib

BMS-986393: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Fludarabine: Specified dose on specified days

Daratumumab: Specified dose on specified days

Pomalidomide: Specified dose on specified days

Dexamethasone: Specified dose on specified days

Carfilzomib: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (141)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
UCLA Hematology/Oncology - Santa Monica Los Angeles California Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia Recruiting
Baptist MD Anderson Cancer Center Jacksonville Florida Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida Recruiting
Local Institution - 0228 Orlando Florida Withdrawn
Winship Cancer Institute, Emory University Atlanta Georgia Recruiting
Louisiana State University Health Sciences Shreveport Shreveport Louisiana Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Local Institution - 0219 Minneapolis Minnesota Withdrawn
Weill Cornell Medical College New York New York Recruiting
Local Institution - 0221 Stony Brook New York Withdrawn
Levine Cancer Institute Charlotte North Carolina Recruiting
Levine Cancer Institute Charlotte North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Local Institution - 0097 Philadelphia Pennsylvania Active Not Recruiting
AHN West Penn Hospital Pittsburgh Pennsylvania Recruiting
Local Institution - 0227 Charleston South Carolina Withdrawn
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Hospital Italiano de Buenos Aires ABB Buenos Aires F.D. Recruiting
Local Institution - 0214 ABB Buenos Aires F.D. Withdrawn
Hospital Aleman Buenos Aires Buenos Aires F.D. Recruiting
Royal Prince Alfred Hospital Camperdown New South Wales Recruiting
Liverpool Hospital Liverpool New South Wales Recruiting
Princess Alexandra Hospital Brisbane Queensland Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Monash Health Clayton Victoria Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Fiona Stanley Hospital Murdoch Western Australia Recruiting
Ordensklinikum Linz GmbH Elisabethinen Linz Upper Austria Recruiting
Hanusch-Krankenhaus Vienna Austria Recruiting
Antwerp University Hospital Edegem Antwerpen Recruiting
Cliniques universitaires Saint-Luc Brussels Bruxelles-Capitale, Région de Recruiting
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne Yvoir Namur Recruiting
UZ Gent Ghent Oost-Vlaanderen Recruiting
Local Institution - 0012 Nova Lima Minas Gerais Not Yet Recruiting

+ 101 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06615479 on ClinicalTrials.gov ↗ ← All trials in the USA