Recruiting

Phase 3

BMS-986393 vs. Standard RegimensA 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)

Sponsor:

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

Code:

NCT06615479

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986393

Cyclophosphamide

Fludarabine

Daratumumab

Pomalidomide

Study Details

Brief 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.

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Study ID

NCT06615479

Start date

Mar 12, 2025

Status verified date

Aug, 2026

Completion date

Jun 22, 2032

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

active comparator: Arm B

Interventions

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

Primary outcome measure

Progression Free Survival (PFS) [ Time Frame: Up to 5 years after the last participant is randomized ]
Minimal residual disease (MRD)-negativity in complete response (CR) [ Time Frame: Up to 1 year after the last participant is randomized ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Susan Bal, Site 0071

UCLA Hematology/Oncology - Santa Monica

Recruiting

Los Angeles, California, United States, 90404

Contacts

Sarah Larson, Site 0032

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Stefan Ciurea, Site 0050

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Kimberley Doucette, Site 0223

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Maxim Norkin, Site 0231

University of Miami Hospital and Clinics, Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Damian Green, Site 0130

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Nisha Joseph, Site 0058

Louisiana State University Health Sciences Shreveport

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Shashank Cingam, Site 0218

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Raphael Szalat, Site 0196

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Mateo Mejia Saldarriaga, Site 0229

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Barry Paul, Site 0216

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Barry Paul, Site 0067

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Sandra Mazzoni, Site 0193

AHN West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Santhosh Sadashiv, Site 0232

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Oren Pasvolsky, Site 0184

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Brian McClune, Site 0044

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Nizar Bahlis, Site 0069

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Hannah Cherniawsky, Site 0003

QEII Health Sciences Centre - Victoria General Site

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Darrell White, Site 0004

Hamilton Health Sciences-Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V5C2

Contacts

Hira Mian, Site 0192

CIUSSS de l'Est-de-l'Île-de-Montréal

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Richard LeBlanc, Site 0001

More Information

Sponsor

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

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company on 2026-08-18.