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

NCT ID: NCT06153251

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2030-05-02

Brief Summary

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

Detailed Description

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Conditions

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Relapsed and/or Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Administration of BMS-986453

Group Type EXPERIMENTAL

BMS-986453

Intervention Type DRUG

Specified dose on specified days

Fludarabine

Intervention Type DRUG

Specified dose on specified days

Cyclophosphamide

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986453

Specified dose on specified days

Intervention Type DRUG

Fludarabine

Specified dose on specified days

Intervention Type DRUG

Cyclophosphamide

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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 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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status RECRUITING

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, United States

Site Status RECRUITING

Stanford University Medical Center

Stanford, California, United States

Site Status RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Local Institution - 0008

Nashville, Tennessee, United States

Site Status NOT_YET_RECRUITING

Tennessee Oncology

Nashville, Tennessee, United States

Site Status RECRUITING

Swedish Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Hôpital Saint-Louis

Paris, , France

Site Status RECRUITING

Universitaetsklinikum Koeln

Cologne, , Germany

Site Status RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, , Spain

Site Status RECRUITING

Countries

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United States France Germany Spain

Central Contacts

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BMS Study Connect www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Luciano Costa, Site 0001

Role: primary

205-934-9695

MURALI JANAKIRAM, Site 0003

Role: primary

626-201-5710

Alfred Chung, Site 0011

Role: primary

000-000-0000

Surbhi Sidana, Site 0006

Role: primary

650-723-0822

Tara Gregory, Site 0013

Role: primary

720-754-4800

Noffar Bar, Site 0005

Role: primary

000-000-0000

Doris Hansen, Site 0016

Role: primary

601-812-3214

Clifton Mo, Site 0023

Role: primary

202-689-9961

Adriana Rossi, Site 0010

Role: primary

646-962-6500

Sham Mailankody, Site 0004

Role: primary

646-608-3712

Site 0008

Role: primary

Jesus Berdeja, Site 0020

Role: primary

615-329-0570

Swathi Namburi, Site 0012

Role: primary

206-386-6738

Bertrand Arnulf, Site 0019

Role: primary

33142499472

Christof Scheid, Site 0017

Role: primary

492214786296

Marc-Steffen Raab, Site 0021

Role: primary

496221565427

Hermann Einsele, Site 0018

Role: primary

+4994120140202

Paula Rodriguez Otero, Site 0015

Role: primary

+0034948254000 0 000

Maria Victoria Mateos Manteca, Site 0014

Role: primary

34923291100

Related Links

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Other Identifiers

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CA119-0002

Identifier Type: -

Identifier Source: org_study_id

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