Relapsed and/or Refractory Multiple Myeloma
Conditions
Keywords
Dual Targeting, BCMAxGPRC5D, GPRC5DxBCMA, BMS-986453, CAR T, CART, Multiple Myeloma, Relapsed and/or Refractory
Brief summary
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Interventions
DRUGBMS-986453
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
Sponsors
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with AEs leading to death | Up to 4 years |
| Number of participants with dose-limiting toxicities (DLTs) | Up to 4 years |
| Number of participants with treatment-emergent adverse events (AEs) | Up to 4 years |
| Number of participants with AEs leading to discontinuation | Up to 4 years |
| Number of participants with serious adverse events (SAEs) | Up to 4 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 4 years | — |
| Time to response (TTR) | Up to 4 years | — |
| Time to complete response (TTCR) | Up to 4 years | — |
| Duration of response (DOR) | Up to 4 years | — |
| Duration of complete response (DOCR) | Up to 4 years | — |
| Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) | Up to 4 years | — |
| Overall response rate (ORR) | Up to 4 years | — |
| Complete response rate (CRR) | Up to 4 years | — |
| Persistence of BMS-986453 in peripheral blood | Up to 4 years | Defined as a transgene count greater than or equal to the lower limit of detection (LLOD) |
| Expansion rate | Up to 4 years | Defined as Cmax divided by Tmax |
| Maximum observed concentration (Cmax) | Up to 4 years | — |
| Time of maximum observed concentration (Tmax) | Up to 4 years | — |
| Number of participants with very good partial response (VGPR) or better | Up to 4 years | — |
| Progression-free survival (PFS) | Up to 4 years | — |
Countries
France, Germany, Spain, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed