A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT06121843
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 111
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm C: BMS-986393 + Iberdomide BMS-986393 - Arm B: BMS-986393 + Mezigdomide BMS-986393 - Arm A: BMS-986393 + Alnuctamab BMS-986393 - Arm B: BMS-986393 + Mezigdomide Mezigdomide - Arm C: BMS-986393 + Iberdomide Iberdomide - Arm A: BMS-986393 + Alnuctamab Alnuctamab -
- Primary Outcome Measures
Name Time Method Incidence of AEs leading to discontinuation Up to 2 years Number of Deaths Up to 2 years Incidence of adverse events (AEs) Up to 2 years Incidence of adverse events of special interest (AESI) Up to 2 years Incidence of serious adverse events (SAEs) Up to 2 years Establish recommended Phase 2 dose (RP2D) Up to 2 years
- Secondary Outcome Measures
Name Time Method Complete response rate (CRR) Up to 2 years Maximum observed concentration (Cmax) Up to 2 years Time of maximum observed concentration (tmax) Up to 2 years Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] Up to 2 years Overall response rate (ORR) Up to 2 years Very good partial response rate (VGPRR) Up to 2 years
Trial Locations
- Locations (19)
University Of Nebraska Medical Center
๐บ๐ธOmaha, Nebraska, United States
University of Alabama at Birmingham
๐บ๐ธBirmingham, Alabama, United States
Local Institution - 0002
๐บ๐ธPhoenix, Arizona, United States
City of Hope Comprehensive Cancer Center
๐บ๐ธDuarte, California, United States
Local Institution - 0005
๐บ๐ธJacksonville, Florida, United States
Northside Hospital
๐บ๐ธAtlanta, Georgia, United States
Beth Israel Deaconess Medical Center
๐บ๐ธBoston, Massachusetts, United States
Dana-Farber Cancer Institute
๐บ๐ธBoston, Massachusetts, United States
Local Institution - 0001
๐บ๐ธRochester, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center
๐บ๐ธHackensack, New Jersey, United States
Roswell Park Cancer Institute
๐บ๐ธBuffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center
๐บ๐ธNew York, New York, United States
Columbia University Irving Medical Center
๐บ๐ธNew York, New York, United States
Memorial Sloan Kettering Cancer Center
๐บ๐ธNew York, New York, United States
Local Institution - 0023
๐บ๐ธPittsburgh, Pennsylvania, United States
Local Institution - 0025
๐บ๐ธNashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
๐บ๐ธHouston, Texas, United States
Tom Baker Cancer Center
๐จ๐ฆCalgary, Alberta, Canada
Local Institution - 0024
๐จ๐ฆToronto, Ontario, Canada