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
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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RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2024-01-23
2030-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of BMS-986453
BMS-986453
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Interventions
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BMS-986453
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
INDUSTRY
Responsible Party
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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
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Local Institution - 0008
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Swedish Medical Center
Seattle, Washington, United States
Hôpital Saint-Louis
Paris, , France
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Countries
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Central Contacts
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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
MURALI JANAKIRAM, Site 0003
Role: primary
Alfred Chung, Site 0011
Role: primary
Surbhi Sidana, Site 0006
Role: primary
Tara Gregory, Site 0013
Role: primary
Noffar Bar, Site 0005
Role: primary
Doris Hansen, Site 0016
Role: primary
Clifton Mo, Site 0023
Role: primary
Adriana Rossi, Site 0010
Role: primary
Sham Mailankody, Site 0004
Role: primary
Site 0008
Role: primary
Jesus Berdeja, Site 0020
Role: primary
Swathi Namburi, Site 0012
Role: primary
Bertrand Arnulf, Site 0019
Role: primary
Christof Scheid, Site 0017
Role: primary
Marc-Steffen Raab, Site 0021
Role: primary
Hermann Einsele, Site 0018
Role: primary
Paula Rodriguez Otero, Site 0015
Role: primary
Maria Victoria Mateos Manteca, Site 0014
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA119-0002
Identifier Type: -
Identifier Source: org_study_id
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