Multiple Myeloma Clinical Trial
Official title:
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
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).
| Status | Recruiting |
| Enrollment | 111 |
| Est. completion date | August 1, 2028 |
| Est. primary completion date | August 1, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution - 0013 | Calgary | Alberta |
| Canada | Local Institution - 0024 | Toronto | Ontario |
| United States | Northside Hospital | Atlanta | Georgia |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Local Institution - 0011 | Boston | Massachusetts |
| United States | Local Institution - 0027 | Boston | Massachusetts |
| United States | Local Institution - 0007 | Buffalo | New York |
| United States | City of Hope Comprehensive Cancer Center | Duarte | California |
| United States | Local Institution - 0004 | Hackensack | New Jersey |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Local Institution - 0005 | Jacksonville | Florida |
| United States | Local Institution - 0025 | Nashville | Tennessee |
| United States | Columbia University Irving Medical Center | New York | New York |
| United States | Laura and Isaac Perlmutter Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Local Institution - 0010 | Omaha | Nebraska |
| United States | Local Institution - 0002 | Phoenix | Arizona |
| United States | Local Institution - 0023 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0001 | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | Up to 2 years | ||
| Primary | Incidence of serious adverse events (SAEs) | Up to 2 years | ||
| Primary | Incidence of adverse events of special interest (AESI) | Up to 2 years | ||
| Primary | Incidence of AEs leading to discontinuation | Up to 2 years | ||
| Primary | Number of Deaths | Up to 2 years | ||
| Primary | Establish recommended Phase 2 dose (RP2D) | Up to 2 years | ||
| Secondary | Overall response rate (ORR) | Up to 2 years | ||
| Secondary | Complete response rate (CRR) | Up to 2 years | ||
| Secondary | Very good partial response rate (VGPRR) | Up to 2 years | ||
| Secondary | Maximum observed concentration (Cmax) | Up to 2 years | ||
| Secondary | Time of maximum observed concentration (tmax) | Up to 2 years | ||
| Secondary | Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] | Up to 2 years |
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