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

NCT06153251 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CA119-00022023-506003-26-00
• Study Type: interventional
• Target: 187
• Locations: 4 countries
• Sites: 19

Brief Summary

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

Conditions

Relapsed and/or Refractory Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Number of participants with treatment-emergent adverse events (AEs)

  Up to 4 years

• Number of participants with serious adverse events (SAEs)

  Up to 4 years

• Number of participants with AEs leading to discontinuation

  Up to 4 years

• Number of participants with AEs leading to death

  Up to 4 years

• Number of participants with dose-limiting toxicities (DLTs)

  Up to 4 years

Secondary Outcomes (14)

• Maximum observed concentration (Cmax)

  Up to 4 years

• Time of maximum observed concentration (Tmax)

  Up to 4 years

• Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

  Up to 4 years

• Overall response rate (ORR)

  Up to 4 years

• Complete response rate (CRR)

  Up to 4 years

Study Arms (1)

Administration of BMS-986453

EXPERIMENTAL

Drug: BMS-986453; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

BMS-986453 DRUG

Specified dose on specified days

Administration of BMS-986453

Fludarabine DRUG

Specified dose on specified days

Also known as: FludAra, Oforta

Administration of BMS-986453

Cyclophosphamide DRUG

Specified dose on specified days

Also known as: Cytoxan, Cytoxan Lyophilized, Neosar

Administration of BMS-986453

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participants must have adequate organ function.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (19)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, 94143, United States

RECRUITING

Stanford University Medical Center

Stanford, California, 94305, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Local Institution - 0008

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Hôpital Saint-Louis

Paris, 75010, France

RECRUITING

Universitaetsklinikum Koeln

Cologne, 50937, Germany

RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, D-69120, Germany

RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma

Interventions

fludarabine; fludarabine phosphate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: January 23, 2024
• Primary Completion (Estimated): May 2, 2030
• Study Completion (Estimated): May 2, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DE (3); US (13); FR (1); ES (2)