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
- Diseases
- Multiple myeloma
- 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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alberta Health Services AHS - Foothills Medical Centre FMC Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| University of Alberta - Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| University Health Network UHN - Princess Margaret Hospital PMH Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Leicester | United Kingdom | Withdrawn |
| - Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Withdrawn |
| NIHR UCLH Clinical Research Facility Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| UAB Comprehensive Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| John Theurer Cancer Center At Hackensack UMC Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.