RECRUITING

A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

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Conditions

Multiple MyelomaBMS-986393Relapsed Multiple MyelomaRefractory Multiple MyelomaFirst-in-humanAlnuctamabMezigdomideIberdomideCC-95266GPRC5DGPRC5D CAR TCell TherapyCAR T cell therapyCombination therapyelranatamabarlocabtagene 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 establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).

Official Title

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component

Quick Facts

Study Start:2024-02-22
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06121843

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. * History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1 and Part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2).
  2. * Measurable multiple myeloma (MM).
  3. * Eastern Cooperative Oncology Group performance status of 0-1.
  1. * Prior treatment with alnuctamab (Arm A), mezigdomide (Arm B), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
  2. * Prior treatment with GPRC5D-targeting therapies.

Contacts and Locations

Study Contact

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

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Local Institution - 0023
Pittsburgh, Pennsylvania, 15232
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
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 Date2024-02-22
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2024-02-22
Study Completion Date2028-08-01

Terms related to this study

Keywords Provided by Researchers

  • BMS-986393
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • First-in-human
  • Alnuctamab
  • Mezigdomide
  • Iberdomide
  • CC-95266
  • GPRC5D
  • GPRC5D CAR T
  • Cell Therapy
  • CAR T cell therapy
  • Combination therapy
  • elranatamab
  • arlocabtagene autoleucel
  • arlo-cel

Additional Relevant MeSH Terms

  • Multiple Myeloma