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

NCT ID: NCT05372354

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2026-10-12

Brief Summary

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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).

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 Arm A: Dose Finding

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Tazemetostat

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Part 1 Arm B: Dose Finding

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Part 1 Arm C: Dose Finding

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Trametinib

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Part 2 Arm D: Dose Expansion

Group Type ACTIVE_COMPARATOR

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Part 2 Arm E: Dose Expansion

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Tazemetostat

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Part 2 Arm G: Dose Expansion

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Trametinib

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Interventions

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CC-92480

Specified dose on specified days

Intervention Type DRUG

Tazemetostat

Specified dose on specified days

Intervention Type DRUG

BMS-986158

Specified dose on specified days

Intervention Type DRUG

Trametinib

Specified dose on specified days

Intervention Type DRUG

Dexamethasone

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986348

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status RECRUITING

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Alberta Health Services AHS - Foothills Medical Centre FMC

Calgary, Alberta, Canada

Site Status RECRUITING

University of Alberta - Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

University Health Network UHN - Princess Margaret Hospital PMH

Toronto, Ontario, Canada

Site Status RECRUITING

Oslo University Hospital

Oslo, Outside US and Canada, Norway

Site Status RECRUITING

ICO - Hospital Germans Trias i Pujol

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status RECRUITING

The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Site Status RECRUITING

Local Institution - 0001

Leicester, Leicestershire, United Kingdom

Site Status WITHDRAWN

Local Institution - 0014

Liverpool, Merseyside, United Kingdom

Site Status WITHDRAWN

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Site Status RECRUITING

NIHR UCLH Clinical Research Facility

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Canada Norway Spain United Kingdom

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Luciano Costa, Site 0002

Role: primary

205-934-9695

Syed Abbas Ali, Site 0015

Role: primary

443-287-7104

Monique Hartley-Brown, Site 0010

Role: primary

857-299-5736

David Siegel, Site 0013

Role: primary

551-996-8704

Saad Usmani, Site 0007

Role: primary

Nizar Bahlis, Site 0009

Role: primary

4039441880

Michael Chu, Site 0008

Role: primary

7804328757

Donna Reece, Site 0004

Role: primary

4169462824

Fredrik Hellem Schjesvold, Site 0012

Role: primary

+4799697796

Albert Oriol Rocafiguera, Site 0011

Role: primary

34934978987

Joaquin Martinez Lopez, Site 0005

Role: primary

34913908525

Enrique Ocio, Site 0003

Role: primary

+34649391848

Emma Searle, Site 0017

Role: primary

4401614463869

Karthik Ramasamy, Site 0016

Role: primary

+4401782674844

Rakesh Popat, Site 0006

Role: primary

111-111-1111

Related Links

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Other Identifiers

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2023-509384-25

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1269-5704

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA057-003

Identifier Type: -

Identifier Source: org_study_id

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