Cyclophosphamide: Specified dose on specified days
Study summary
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with treatment-emergent adverse events (AEs) — Up to 4 years
Number of participants with serious adverse events (SAEs) — Up to 4 years
Number of participants with AEs leading to discontinuation — Up to 4 years
Number of participants with AEs leading to death — Up to 4 years
Number of participants with dose-limiting toxicities (DLTs) — Up to 4 years
Trial sites (19)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
City of Hope Comprehensive Cancer Center
Duarte
California
Recruiting
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco
California
Recruiting
Stanford University Medical Center
Stanford
California
Recruiting
Colorado Blood Cancer Institute
Denver
Colorado
Recruiting
Yale Cancer Center
New Haven
Connecticut
Recruiting
Moffitt Cancer Center
Tampa
Florida
Recruiting
Dana-Farber Cancer Institute
Boston
Massachusetts
Recruiting
Icahn School of Medicine at Mount Sinai
New York
New York
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Local Institution - 0008
Nashville
Tennessee
Not Yet Recruiting
Tennessee Oncology
Nashville
Tennessee
Recruiting
Swedish Medical Center
Seattle
Washington
Recruiting
Hôpital Saint-Louis
Paris
France
Recruiting
Universitaetsklinikum Koeln
Cologne
Germany
Recruiting
Universitaetsklinikum Heidelberg
Heidelberg
Germany
Recruiting
Universitaetsklinikum Wuerzburg
Würzburg
Germany
Recruiting
Clinica Universidad de Navarra
Pamplona
Navarre
Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca
Spain
Recruiting
More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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