Recruiting
Phase 1
Phase 2

CC-92480, Treatments

Sponsor:

Bristol-Myers Squibb

Code:

NCT05372354

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CC-92480

Tazemetostat

BMS-986158

Trametinib

Dexamethasone

Study Details

Brief 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).

Conditions

Multiple Myeloma

Study ID

NCT05372354

Start date

Oct 18, 2022

Status verified date

Aug, 2025

Completion date

Oct 12, 2026

Anticipated

Primary completion date

Oct 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome 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 is not 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 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 clinically significant light-chain amyloidosis.
  • Impaired cardiac function or clinically significant cardiac disease
  • Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections 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, or trametinib
  • Previously received allogeneic stem-cell transplant at any time or received autologous 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 is shorter) prior to initiating study treatment
  • COVID-19 vaccine within 14 days prior to C1D1

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Arm A: Dose Finding

experimental: Part 1 Arm B: Dose Finding

experimental: Part 1 Arm C: Dose Finding

active comparator: Part 2 Arm D: Dose Expansion

experimental: Part 2 Arm E: Dose Expansion

experimental: Part 2 Arm G: Dose Expansion

Interventions

CC-92480

Specified dose on specified days

Tazemetostat

Specified dose on specified days

BMS-986158

Specified dose on specified days

Trametinib

Specified dose on specified days

Dexamethasone

Specified dose on specified days

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years ]
  • Number of participants with Serious AEs [ Time Frame: Up to approximately 4 years ]
  • Number of participants with AEs meeting protocol-defined DLT criteria [ Time Frame: Up to approximately 4 years ]
  • Number of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 4 years ]
  • Number of deaths [ Time Frame: Up to approximately 4 years ]
  • Establish recommended Phase 2 dose (RP2D) [ Time Frame: Up to approximately 2 years ]
  • Establish dosing schedule of each combination for Part 2 Dose Expansion [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

855-907-3286Clinical.Trials@bms.com

Locations

UAB Comprehensive Cancer Center

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Luciano Costa, Site 0002

205-934-9695

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Syed Abbas Ali, Site 0015

443-287-7104

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Monique Hartley-Brown, Site 0010

857-299-5736

John Theurer Cancer Center at Hackensack UMC

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

David Siegel, Site 0013

551-996-8704

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Alberta Health Services AHS - Foothills Medical Centre FMC

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Nizar Bahlis, Site 0009

4039441880

University of Alberta - Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Michael Chu, Site 0008

7804328757

University Health Network UHN - Princess Margaret Hospital PMH

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Donna Reece, Site 0004

4169462824

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Keywords

  • BMS-986348
  • CC-92480
  • BMS-986158
  • Dexamethasone
  • Tazemetostat
  • Trametinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2025-09-05.