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Clinical Trials in the USA / NCT05372354
Recruiting Phase 1/2

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 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2022-10-18
Last updated
2025-09-05

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

CC-92480 →Tazemetostat →BMS-986158 →Trametinib →Dexamethasone →

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
UAB Comprehensive Cancer Center Birmingham Alabama Recruiting
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
John Theurer Cancer Center at Hackensack UMC Hackensack New Jersey Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Alberta Health Services AHS - Foothills Medical Centre FMC Calgary Alberta Recruiting
University of Alberta - Cross Cancer Institute Edmonton Alberta Recruiting
University Health Network UHN - Princess Margaret Hospital PMH Toronto Ontario Recruiting
Oslo University Hospital Oslo Outside US and Canada Recruiting
ICO - Hospital Germans Trias i Pujol Barcelona Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Universitario Marques de Valdecilla Santander Spain Recruiting
The Christie NHS Foundation Trust Manchester Greater Manchester Recruiting
Local Institution - 0001 Leicester Leicestershire Withdrawn
Local Institution - 0014 Liverpool Merseyside Withdrawn
Churchill Hospital Oxford Oxfordshire Recruiting
NIHR UCLH Clinical Research Facility London United Kingdom Recruiting

More Bristol-Myers Squibb trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05372354 on ClinicalTrials.gov ↗ ← All trials in the USA