RECRUITING

A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

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Conditions

Relapsed and/or Refractory Multiple MyelomaDual TargetingBCMAxGPRC5DGPRC5DxBCMABMS-986453CAR TCARTMultiple MyelomaRelapsed and/or Refractory

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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 assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

Official Title

A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma

Quick Facts

Study Start:2024-01-23
Study Completion:2027-11-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06153251

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. * Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
  2. * Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
  3. * Participants in Part A and Part B Cohort 1 must have received at least 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent.
  4. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. * Participants must have adequate organ function.
  1. * Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
  2. * Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
  3. * Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.

Contacts and Locations

Study Contact

BMS Study Connect www.BMSStudyConnect.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)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Yale Cancer Center
New Haven, Connecticut, 06520
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Local Institution - 0023
Boston, Massachusetts, 02215
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Local Institution - 0008
Nashville, Tennessee, 37203
United States
Local Institution - 0020
Nashville, Tennessee, 37203
United States
Swedish Medical Center
Seattle, Washington, 98104
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 Date2024-01-23
Study Completion Date2027-11-29

Study Record Updates

Study Start Date2024-01-23
Study Completion Date2027-11-29

Terms related to this study

Keywords Provided by Researchers

  • Dual Targeting
  • BCMAxGPRC5D
  • GPRC5DxBCMA
  • BMS-986453
  • CAR T
  • CART
  • Multiple Myeloma
  • Relapsed and/or Refractory

Additional Relevant MeSH Terms

  • Relapsed and/or Refractory Multiple Myeloma