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

April 25, 2024 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

111

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Susan Bal, Site 0008
          • Phone Number: 205-934-1908
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
          • Myo Htut, Site 0028
          • Phone Number: 626-256-4673
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Jessica Liegel, Site 0027
          • Phone Number: 617-667-9922
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Not yet recruiting
        • Local Institution - 0010
        • Contact:
          • Site 0010
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Sham Mailankody, Site 0012
          • Phone Number: 646-608-3712
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Divaya Bhutani, Site 0009
          • Phone Number: 646-317-6303
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center
        • Contact:
          • Jingmei Hsu, Site 0022
          • Phone Number: 646-501-4848
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Withdrawn
        • Local Institution - 0023
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Krina Patel, Site 0003
          • Phone Number: 713-792-6662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: BMS-986393 + Alnuctamab
Drug: BMS-986393
Specified dose on specified days
Other Names:
  • CC-95266
Drug: Alnuctamab
Specified dose on specified days
Other Names:
  • BMS-986349
  • CC-93269
  • EM901
Experimental: Arm B: BMS-986393 + Mezigdomide
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Drug: BMS-986393
Specified dose on specified days
Other Names:
  • CC-95266
Experimental: Arm C: BMS-986393 + Iberdomide
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Drug: BMS-986393
Specified dose on specified days
Other Names:
  • CC-95266

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of AEs leading to discontinuation
Time Frame: Up to 2 years
Up to 2 years
Incidence of adverse events (AEs)
Time Frame: Up to 2 years
Up to 2 years
Incidence of serious adverse events (SAEs)
Time Frame: Up to 2 years
Up to 2 years
Incidence of adverse events of special interest (AESI)
Time Frame: Up to 2 years
Up to 2 years
Number of Deaths
Time Frame: Up to 2 years
Up to 2 years
Establish recommended Phase 2 dose (RP2D)
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR)
Time Frame: Up to 2 years
Up to 2 years
Complete response rate (CRR)
Time Frame: Up to 2 years
Up to 2 years
Very good partial response rate (VGPRR)
Time Frame: Up to 2 years
Up to 2 years
Maximum observed concentration (Cmax)
Time Frame: Up to 2 years
Up to 2 years
Time of maximum observed concentration (tmax)
Time Frame: Up to 2 years
Up to 2 years
Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)]
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA088-1005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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