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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Relapsed or refractory multiple myeloma (MM) and must: 1.

have documented disease progression during or after their last myeloma therapy. 2. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05372354
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bristol-Myers Squibb
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Norway, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Part 1 Arm A: Dose Finding

Experimental: Part 1 Arm B: Dose Finding

Experimental: Part 1 Arm C: Dose Finding

Active Comparator: Part 2 Arm D: Dose Expansion

Experimental: Part 2 Arm E: Dose Expansion

Experimental: Part 2 Arm F: Dose Expansion

Experimental: Part 2 Arm G: Dose Expansion