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A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
RECRUITINGPhase 1Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Actively Recruiting
PhasePhase 1
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Started2024-01-23
Est. completion2030-05-02
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →
NCT06153251
Summary
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Eligibility
Age: 18 Years+Healthy volunteers accepted
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. Other protocol-defined inclusion/exclusion criteria apply
Conditions2
CancerRelapsed and/or Refractory Multiple Myeloma
Locations13 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Luciano Costa, Site 0001205-934-9695
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
MURALI JANAKIRAM, Site 0003626-201-5710
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
Alfred Chung, Site 0011000-000-0000
Stanford University Medical Center
Stanford, California, 94305
Surbhi Sidana, Site 0006650-723-0822
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Tara Gregory, Site 0013720-754-4800
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Actively Recruiting
PhasePhase 1
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Started2024-01-23
Est. completion2030-05-02
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →
NCT06153251