RECRUITING

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)

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Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)Relapsed or Refractory Multiple MyelomaMultiple MyelomaBMS-986393Chimeric Antigen Receptor T-cell (CAR T-cell)CAR T-cell TherapyArlocabtagene AutoleucelArlo-cel

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-03-12
Study Completion:2032-06-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06615479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site#
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0071
Birmingham, Alabama, 35205
United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
United States
Local Institution - 0130
Miami, Florida, 33136
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
Local Institution - 0196
Boston, Massachusetts, 02118
United States
Local Institution - 0067
Charlotte, North Carolina, 28204
United States
Local Institution - 0216
Winston-Salem, North Carolina, 27157
United States
Local Institution - 0193
Cleveland, Ohio, 44195
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Local Institution - 0044
Salt Lake City, Utah, 84112
United States
Local Institution - 0195
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

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

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-12
Study Completion Date2032-06-22

Study Record Updates

Study Start Date2025-03-12
Study Completion Date2032-06-22

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Relapsed or Refractory Multiple Myeloma (RRMM)