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

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: BMS-986393; Drug: Mezigdomide; Drug: Iberdomide; Drug: Alnuctamab

• 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

Study Timeline

• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Study Start: 2024-02-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm B: BMS-986393 + Mezigdomide	BMS-986393	-
Arm A: BMS-986393 + Alnuctamab	BMS-986393	-
Arm C: BMS-986393 + Iberdomide	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)

Mayo Clinic in Arizona - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester, Minnesota; 🇺🇸 Rochester, Minnesota, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University Of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

John Theurer Cancer Center at Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Laura and Isaac Perlmutter Cancer Center; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Local Institution - 0023; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0025; 🇺🇸 Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Tom Baker Cancer Center; 🇨🇦 Calgary, Alberta, Canada

Local Institution - 0024; 🇨🇦 Toronto, Ontario, Canada