NCT05372354 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 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2022-10-18 |
| Primary Completion | 2026-10-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 260 participants in total. It began in 2022-10-18 with a primary completion date of 2026-10-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT05372354 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05372354 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05372354 currently recruiting?
Yes, NCT05372354 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT05372354 trial being conducted?
This trial is being conducted at Birmingham, United States, Baltimore, United States, Boston, United States, Hackensack, United States and 11 additional locations.
Who is sponsoring the NCT05372354 clinical trial?
NCT05372354 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 260 participants.