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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
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
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
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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

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Arm C: BMS-986393 + IberdomideBMS-986393-
Arm B: BMS-986393 + MezigdomideBMS-986393-
Arm A: BMS-986393 + AlnuctamabBMS-986393-
Arm B: BMS-986393 + MezigdomideMezigdomide-
Arm C: BMS-986393 + IberdomideIberdomide-
Arm A: BMS-986393 + AlnuctamabAlnuctamab-
Primary Outcome Measures
NameTimeMethod
Incidence of AEs leading to discontinuationUp to 2 years
Number of DeathsUp 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
NameTimeMethod
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

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Omaha, Nebraska, United States

University of Alabama at Birmingham

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Birmingham, Alabama, United States

Local Institution - 0002

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Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center

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Duarte, California, United States

Local Institution - 0005

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Jacksonville, Florida, United States

Northside Hospital

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Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center

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Boston, Massachusetts, United States

Dana-Farber Cancer Institute

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Boston, Massachusetts, United States

Local Institution - 0001

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Rochester, Minnesota, United States

John Theurer Cancer Center at Hackensack University Medical Center

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Hackensack, New Jersey, United States

Roswell Park Cancer Institute

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Buffalo, New York, United States

Laura and Isaac Perlmutter Cancer Center

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New York, New York, United States

Columbia University Irving Medical Center

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New York, New York, United States

Memorial Sloan Kettering Cancer Center

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New York, New York, United States

Local Institution - 0023

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Pittsburgh, Pennsylvania, United States

Local Institution - 0025

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Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

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Houston, Texas, United States

Tom Baker Cancer Center

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Calgary, Alberta, Canada

Local Institution - 0024

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Toronto, Ontario, Canada

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