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

Study Purpose

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
  • - 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.
  • - 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.
  • - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • - Participants must have adequate organ function.

Exclusion Criteria:

  • - Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
  • - 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.
  • - 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.
Other protocol-defined inclusion/exclusion criteria apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06153251
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

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

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Germany, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed and/or Refractory Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Administration of BMS-986453

Interventions

Drug: - BMS-986453

Specified dose on specified days

Drug: - Fludarabine

Specified dose on specified days

Drug: - Cyclophosphamide

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300

Site Contact

Luciano Costa, Site 0001

Clinical.Trials@bms.com

205-934-9695

Local Institution - 0003, Duarte, California

Status

Not yet recruiting

Address

Local Institution - 0003

Duarte, California, 91010

Site Contact

Site 0003

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0011, San Francisco, California

Status

Not yet recruiting

Address

Local Institution - 0011

San Francisco, California, 94143

Site Contact

Site 0011

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0006, Stanford, California

Status

Not yet recruiting

Address

Local Institution - 0006

Stanford, California, 94305

Site Contact

Site 0006

Clinical.Trials@bms.com

855-907-3286

Colorado Blood Cancer Institute, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Site Contact

Tara Gregory, Site 0013

Clinical.Trials@bms.com

720-754-4800

Local Institution - 0005, New Haven, Connecticut

Status

Not yet recruiting

Address

Local Institution - 0005

New Haven, Connecticut, 06510

Site Contact

Site 0005

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0016, Tampa, Florida

Status

Not yet recruiting

Address

Local Institution - 0016

Tampa, Florida, 33612

Site Contact

Site 0016

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0010, New York, New York

Status

Not yet recruiting

Address

Local Institution - 0010

New York, New York, 10029

Site Contact

Site 0010

Clinical.Trials@bms.com

855-907-3286

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Sham Mailankody, Site 0004

Clinical.Trials@bms.com

646-608-3712

Local Institution - 0008, Nashville, Tennessee

Status

Not yet recruiting

Address

Local Institution - 0008

Nashville, Tennessee, 37203

Site Contact

Site 0008

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0020, Nashville, Tennessee

Status

Not yet recruiting

Address

Local Institution - 0020

Nashville, Tennessee, 37203

Site Contact

Site 0020

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0012, Seattle, Washington

Status

Not yet recruiting

Address

Local Institution - 0012

Seattle, Washington, 98104

Site Contact

Site 0012

Clinical.Trials@bms.com

855-907-3286

International Sites

Local Institution - 0019, Paris, France

Status

Not yet recruiting

Address

Local Institution - 0019

Paris, , 75010

Site Contact

Site 0019

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0017, Köln, Germany

Status

Not yet recruiting

Address

Local Institution - 0017

Köln, , 50937

Site Contact

Site 0017

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0018, Wuerzburg, Germany

Status

Not yet recruiting

Address

Local Institution - 0018

Wuerzburg, , 97080

Site Contact

Site 0018

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0015, Pamplona, Navarra, Spain

Status

Not yet recruiting

Address

Local Institution - 0015

Pamplona, Navarra, 31008

Site Contact

Site 0015

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0014, Salamanca, Spain

Status

Not yet recruiting

Address

Local Institution - 0014

Salamanca, , 37007

Site Contact

Site 0014

Clinical.Trials@bms.com

855-907-3286