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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

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06121843
Collaborator
(none)
111
Enrollment
2
Locations
3
Arms
55
Anticipated Duration (Months)
55.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
111 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 31, 2023
Anticipated Primary Completion Date :
Aug 1, 2028
Anticipated Study Completion Date :
Aug 1, 2028

Arms and Interventions

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: BMS-986393
    Specified dose on specified days
    Other Names:
  • CC-95266

    • Drug: Mezigdomide
    Specified dose on specified days
    Other Names:
  • BMS-986348
  • CC-92480

    		•
    Experimental: Arm C: BMS-986393 + Iberdomide

    Drug: BMS-986393
    Specified dose on specified days
    Other Names:
  • CC-95266

    • Drug: Iberdomide
    Specified dose on specified days
    Other Names:
  • BMS-986382
  • CC-220

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) [Up to 2 years]

    2. Incidence of serious adverse events (SAEs) [Up to 2 years]

    3. Incidence of adverse events of special interest (AESI) [Up to 2 years]

    4. Incidence of AEs leading to discontinuation [Up to 2 years]

    5. Number of Deaths [Up to 2 years]

    6. Establish recommended Phase 2 dose (RP2D) [Up to 2 years]

    Secondary Outcome Measures

    1. Overall response rate (ORR) [Up to 2 years]

    2. Complete response rate (CRR) [Up to 2 years]

    3. Very good partial response rate (VGPRR) [Up to 2 years]

    4. Maximum observed concentration (Cmax) [Up to 2 years]

    5. Time of maximum observed concentration (tmax) [Up to 2 years]

    6. Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] [Up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114
    2 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
    ClinicalTrials.gov Identifier:
    NCT06121843
    Other Study ID Numbers:
    • CA088-1005
    First Posted:
    Nov 8, 2023
    Last Update Posted:
    Nov 8, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
    BMS-986393
    Relapsed Multiple Myeloma
    Refractory Multiple Myeloma
    First-in-human
    Alnuctamab
    Mezigdomide
    Iberdomide
    CC-95266
    GPRC5D
    GPRC5D CAR T
    Cell Therapy
    CAR T cell therapy
    Combination therapy
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Nov 8, 2023