A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

Last updated: March 17, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Bone Neoplasm

Lymphoproliferative Disorders

Leukemia

Treatment

BMS-986158

Trametinib

Tazemetostat

Clinical Study ID

NCT05372354
CA057-003
2021-005167-51
U1111-1269-5704
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Relapsed or refractory multiple myeloma (MM) and must:
  1. Have documented disease progression during or after their last myeloma therapy.

  2. For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidatefor available, established therapies known to provide clinical benefit in MM;For Part 2 Dose Expansion: Be refractory to or have relapsed after at least 2prior lines of therapy that include an immunomodulatory drug (IMiD), aproteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT,eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant isnot a candidate for TRT.

  • Must have measurable disease.

  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

  • Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP).

Exclusion

Exclusion Criteria:

  • Known active or history of central nervous system (CNS) involvement of MM

  • Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly,endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinicallysignificant light-chain amyloidosis.

  • Impaired cardiac function or clinically significant cardiac disease

  • Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomaticinfections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)

  • For Part 1: received prior therapy with CC-92480

  • For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, ortrametinib

  • Previously received allogeneic stem-cell transplant at any time or receivedautologous stem-cell transplant within 12 weeks of initiating study treatment

  • Received any of the following within 14 days prior to initiating study treatment:

  1. Plasmapheresis

  2. Major surgery

  3. Radiation therapy other than local therapy for myeloma associated bone lesions

  4. Use of any systemic anti-myeloma drug therapy

  • Used any investigational agents within 28 days or 5 half-lives (whichever isshorter) prior to initiating study treatment

  • COVID-19 vaccine within 14 days prior to C1D1

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 160
Treatment Group(s): 5
Primary Treatment: BMS-986158
Phase: 1/2
Study Start date:
October 18, 2022
Estimated Completion Date:
October 12, 2026

Connect with a study center

  • Alberta Health Services AHS - Foothills Medical Centre FMC

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Local Institution - 0009

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Local Institution - 0008

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • University of Alberta - Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • Local Institution - 0004

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • University Health Network UHN - Princess Margaret Hospital PMH

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Local Institution - 0012

    Oslo, Outside US And Canada 0450
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo, 0450
    Norway

    Active - Recruiting

  • ICO - Hospital Germans Trias i Pujol

    Barcelona, 08026
    Spain

    Active - Recruiting

  • Local Institution - 0011

    Barcelona, 08026
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Local Institution - 0005

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Local Institution - 0003

    Santander, 39008
    Spain

    Active - Recruiting

  • Local Institution - 0006

    London, Greater London W1T 7HA
    United Kingdom

    Active - Recruiting

  • Local Institution - 0017

    Manchester, Greater Manchester M20 4BX
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, Greater Manchester M20 4BX
    United Kingdom

    Active - Recruiting

  • Leicester Royal Infirmary

    Leicester, Leicestershire LE1 5WW
    United Kingdom

    Site Not Available

  • Local Institution - 0001

    Leicester, Leicestershire LE1 5WW
    United Kingdom

    Site Not Available

  • Local Institution - 0014

    Liverpool, Merseyside L7 8YA
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Active - Recruiting

  • Local Institution - 0016

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Site Not Available

  • NIHR UCLH Clinical Research Facility

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

  • Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

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