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

NCT05372354 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA057-0032023-509384-25U1111-1269-5704
• Study Type: interventional
• Target: 260
• Locations: 5 countries
• Sites: 17

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Number of participants with adverse events (AEs)

  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

  Up to approximately 4 years

• Number of participants with AEs meeting protocol-defined DLT criteria

  Up to approximately 4 years

• Number of participants with AEs leading to discontinuation

  Up to approximately 4 years

• Number of deaths

  Up to approximately 4 years

• Establish recommended Phase 2 dose (RP2D)

  Up to approximately 2 years

• Establish dosing schedule of each combination for Part 2 Dose Expansion

  Up to approximately 2 years

Secondary Outcomes (12)

• Overall response rate (ORR)

  Up to approximately 4 years

• Very good partial response rate (VGPRR)

  Up to approximately 4 years

• Complete response rate (CRR)

  Up to approximately 4 years

• Time-to-response (TTR)

  Up to approximately 4 years

• Duration of response (DOR)

  Up to approximately 4 years

Study Arms (6)

Part 1 Arm A: Dose Finding

EXPERIMENTAL

Drug: CC-92480; Drug: Tazemetostat; Drug: Dexamethasone

Part 1 Arm B: Dose Finding

EXPERIMENTAL

Drug: CC-92480; Drug: BMS-986158; Drug: Dexamethasone

Part 1 Arm C: Dose Finding

EXPERIMENTAL

Drug: CC-92480; Drug: Trametinib; Drug: Dexamethasone

Part 2 Arm D: Dose Expansion

ACTIVE COMPARATOR

Drug: CC-92480; Drug: Dexamethasone

Part 2 Arm E: Dose Expansion

EXPERIMENTAL

Drug: CC-92480; Drug: Tazemetostat; Drug: Dexamethasone

Part 2 Arm G: Dose Expansion

EXPERIMENTAL

Drug: CC-92480; Drug: Trametinib; Drug: Dexamethasone

Interventions

CC-92480 DRUG

Specified dose on specified days

Also known as: BMS-986348

Part 1 Arm A: Dose Finding; Part 1 Arm B: Dose Finding; Part 1 Arm C: Dose Finding; Part 2 Arm D: Dose Expansion; Part 2 Arm E: Dose Expansion; Part 2 Arm G: Dose Expansion

Tazemetostat DRUG

Specified dose on specified days

Part 1 Arm A: Dose Finding; Part 2 Arm E: Dose Expansion

BMS-986158 DRUG

Specified dose on specified days

Part 1 Arm B: Dose Finding

Trametinib DRUG

Specified dose on specified days

Part 1 Arm C: Dose Finding; Part 2 Arm G: Dose Expansion

Dexamethasone DRUG

Specified dose on specified days

Part 1 Arm A: Dose Finding; Part 1 Arm B: Dose Finding; Part 1 Arm C: Dose Finding; Part 2 Arm D: Dose Expansion; Part 2 Arm E: Dose Expansion; Part 2 Arm G: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Plasmapheresis
• Major surgery
• Radiation therapy other than local therapy for myeloma associated bone lesions
• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (17)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35249, United States

RECRUITING

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, 07601, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

Alberta Health Services AHS - Foothills Medical Centre FMC

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

University of Alberta - Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

University Health Network UHN - Princess Margaret Hospital PMH

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Oslo University Hospital

Oslo, Outside US and Canada, 0450, Norway

RECRUITING

ICO - Hospital Germans Trias i Pujol

Barcelona, 08026, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

RECRUITING

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

RECRUITING

Local Institution - 0001

Leicester, Leicestershire, LE1 5WW, United Kingdom

WITHDRAWN

Local Institution - 0014

Liverpool, Merseyside, L7 8YA, United Kingdom

WITHDRAWN

Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

NIHR UCLH Clinical Research Facility

London, W1T 7HA, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma

Interventions

tazemetostat; trametinib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

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

First line of email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 12, 2022
• Study Start: October 18, 2022
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

NO (1); CA (3); US (5); ES (3); GB (5)