A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
About this trial
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BMS-986453
- Fludarabine
- Cyclophosphamide
Treatment groups
187 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov