Assessing BMS-986453 for treating relapsed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of BMS-986453 in patients with relapsed and/or refractory multiple myeloma. Participants must have experienced disease progression after previous treatments and have received at least three prior anti-myeloma regimens. The study involves administering BMS-986453 along with Fludarabine and Cyclophosphamide to assess its therapeutic potential. The goal is to determine how well this dual-targeting approach can manage the disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• UCSF Helen Diller Medical Center at Parnassus Heights
  San Francisco, California, United States Recruiting
• Stanford University Medical Center
  Stanford, California, United States Recruiting
• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.