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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

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

Interventions3

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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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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