Clinical trial

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component

Name
CA088-1005
Description
The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (RRMM).
Trial arms
Trial start
2024-02-22
Estimated PCD
2028-08-01
Trial end
2028-08-01
Status
Recruiting
Phase
Early phase I
Treatment
BMS-986393
Specified dose on specified days
Arms:
Arm A: BMS-986393 + Alnuctamab, Arm B: BMS-986393 + Mezigdomide, Arm C: BMS-986393 + Iberdomide
Other names:
CC-95266
Alnuctamab
Specified dose on specified days
Arms:
Arm A: BMS-986393 + Alnuctamab
Other names:
BMS-986349, CC-93269, EM901
Mezigdomide
Specified dose on specified days
Arms:
Arm B: BMS-986393 + Mezigdomide
Other names:
BMS-986348, CC-92480
Iberdomide
Specified dose on specified days
Arms:
Arm C: BMS-986393 + Iberdomide
Other names:
BMS-986382, CC-220
Size
111
Primary endpoint
Incidence of adverse events (AEs)
Up to 2 years
Incidence of serious adverse events (SAEs)
Up to 2 years
Incidence of adverse events of special interest (AESI)
Up to 2 years
Incidence of AEs leading to discontinuation
Up to 2 years
Number of Deaths
Up to 2 years
Establish recommended Phase 2 dose (RP2D)
Up to 2 years
Eligibility criteria
Inclusion Criteria: * History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1 and Part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2) * Measurable multiple myeloma (MM) * Eastern Cooperative Oncology Group performance status of 0-1 Exclusion Criteria: * Condition that confounds the ability to interpret data from the study * Known active or history of central nervous system (CNS) involvement of MM Note: Other protocol-defined inclusion/exclusion criteria apply
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 111, 'type': 'ESTIMATED'}}
Updated at
2024-04-26

1 organization

4 products

1 indication

Product
BMS-986393
Organization
Juno Therapeutics
Product
Alnuctamab
Product
Iberdomide