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
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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RECRUITING
PHASE1/PHASE2
260 participants
INTERVENTIONAL
2022-10-18
2026-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 Arm A: Dose Finding
CC-92480
Specified dose on specified days
Tazemetostat
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Part 1 Arm B: Dose Finding
CC-92480
Specified dose on specified days
BMS-986158
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Part 1 Arm C: Dose Finding
CC-92480
Specified dose on specified days
Trametinib
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Part 2 Arm D: Dose Expansion
CC-92480
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Part 2 Arm E: Dose Expansion
CC-92480
Specified dose on specified days
Tazemetostat
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Part 2 Arm G: Dose Expansion
CC-92480
Specified dose on specified days
Trametinib
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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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
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Alberta Health Services AHS - Foothills Medical Centre FMC
Calgary, Alberta, Canada
University of Alberta - Cross Cancer Institute
Edmonton, Alberta, Canada
University Health Network UHN - Princess Margaret Hospital PMH
Toronto, Ontario, Canada
Oslo University Hospital
Oslo, Outside US and Canada, Norway
ICO - Hospital Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Local Institution - 0001
Leicester, Leicestershire, United Kingdom
Local Institution - 0014
Liverpool, Merseyside, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
NIHR UCLH Clinical Research Facility
London, , United Kingdom
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Luciano Costa, Site 0002
Role: primary
Syed Abbas Ali, Site 0015
Role: primary
Monique Hartley-Brown, Site 0010
Role: primary
David Siegel, Site 0013
Role: primary
Saad Usmani, Site 0007
Role: primary
Nizar Bahlis, Site 0009
Role: primary
Michael Chu, Site 0008
Role: primary
Donna Reece, Site 0004
Role: primary
Fredrik Hellem Schjesvold, Site 0012
Role: primary
Albert Oriol Rocafiguera, Site 0011
Role: primary
Joaquin Martinez Lopez, Site 0005
Role: primary
Enrique Ocio, Site 0003
Role: primary
Emma Searle, Site 0017
Role: primary
Karthik Ramasamy, Site 0016
Role: primary
Rakesh Popat, Site 0006
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
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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