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NCT05372354RecruitingPhase 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

An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
260 (estimated)
First submitted
6 May 2022
Start date
18 Oct 2022
Primary completion date
12 Oct 2026
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT05372354
EU CT number
2023-509384-25-00
EudraCT number
2021-005167-51

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 260
  • From 18 Oct 2022 to the primary completion date, 12 Oct 2026
  • 17 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
    • Other protocol-defined inclusion/exclusion criteria apply

Other illness

  • 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

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Alberta Health Services AHS - Foothills Medical Centre FMC
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
University of Alberta - Cross Cancer Institute
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EdmontonCanadaRecruiting
University Health Network UHN - Princess Margaret Hospital PMH
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TorontoCanadaRecruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
-
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LeicesterUnited KingdomWithdrawn
-
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomWithdrawn
NIHR UCLH Clinical Research Facility
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
Churchill Hospital
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OxfordUnited KingdomRecruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
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BaltimoreUnited StatesRecruiting
UAB Comprehensive Cancer Center
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BirminghamUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
John Theurer Cancer Center At Hackensack UMC
Coordinator of this site? Confirm its status
HackensackUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.