Recruiting NCT06153251
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986453, Fludarabine, Cyclophosphamide.
- Who it may be relevant to
- Registry conditions: Relapsed and/or Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Germany, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
Overview
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Interventions
- Drug BMS-986453
Specified dose on specified days - Drug Fludarabine
Specified dose on specified days - Drug Cyclophosphamide
Specified dose on specified days
Primary outcome measures
- Number of participants with treatment-emergent adverse events (AEs) [Time frame: Up to 4 years]
- Number of participants with serious adverse events (SAEs) [Time frame: Up to 4 years]
- Number of participants with AEs leading to discontinuation [Time frame: Up to 4 years]
- Number of participants with AEs leading to death [Time frame: Up to 4 years]
- Number of participants with dose-limiting toxicities (DLTs) [Time frame: Up to 4 years]
Secondary outcome measures (12)
- Maximum observed concentration (Cmax) [Time frame: Up to 4 years]
- Time of maximum observed concentration (Tmax) [Time frame: Up to 4 years]
- Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) [Time frame: Up to 4 years]
- Overall response rate (ORR) [Time frame: Up to 4 years]
- Complete response rate (CRR) [Time frame: Up to 4 years]
- Number of participants with very good partial response (VGPR) or better [Time frame: Up to 4 years]
- Progression-free survival (PFS) [Time frame: Up to 4 years]
- Overall survival (OS) [Time frame: Up to 4 years]
- Time to response (TTR) [Time frame: Up to 4 years]
- Time to complete response (TTCR) [Time frame: Up to 4 years]
- Duration of response (DOR) [Time frame: Up to 4 years]
- Duration of complete response (DOCR) [Time frame: Up to 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- University of Alabama at Birmingham — Birmingham
- City of Hope Comprehensive Cancer Center — Duarte
- UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco
- Stanford University Medical Center — Stanford
- Colorado Blood Cancer Institute — Denver
- Yale Cancer Center — New Haven
- Moffitt Cancer Center — Tampa
- Dana-Farber Cancer Institute — Boston
- … and 5 more centers
Germany · 3 centers
- Universitaetsklinikum Koeln — Cologne
- Universitaetsklinikum Heidelberg — Heidelberg
- Universitaetsklinikum Wuerzburg — Würzburg
Spain · 2 centers
- Clinica Universidad de Navarra — Pamplona
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca — Salamanca
France · 1 center
- Hôpital Saint-Louis — Paris
Identifiers
NCT: NCT06153251 · CA119-0002 · 2023-506003-26-00