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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BMS-986453
DrugSpecified dose on specified days
Fludarabine
DrugSpecified dose on specified days
Cyclophosphamide
DrugSpecified dose on specified days
Treatment groups
187 Participants
are divided into 1 treatment groupGroup A: Administration of BMS-986453Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of participants with treatment-emergent adverse events (AEs)
Time frame
Up to 4 years2
Number of participants with serious adverse events (SAEs)
Time frame
Up to 4 years3
Number of participants with AEs leading to discontinuation
Time frame
Up to 4 years4
Number of participants with AEs leading to death
Time frame
Up to 4 yearsSecondary outcomes
1
Maximum observed concentration (Cmax)
Time frame
Up to 4 years2
Time of maximum observed concentration (Tmax)
Time frame
Up to 4 years3
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time frame
Up to 4 years4
Overall response rate (ORR)
Time frame
Up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov