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
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT05372354
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
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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 at least 2 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.
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Must have measurable disease.
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
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Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP).
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Known active or history of central nervous system (CNS) involvement of MM
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Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
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Impaired cardiac function or clinically significant cardiac disease
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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)
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For Part 1: received prior therapy with CC-92480
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For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
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Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
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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
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Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
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COVID-19 vaccine within 14 days prior to C1D1
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Arm A: Dose Finding CC-92480 - Part 1 Arm A: Dose Finding Tazemetostat - Part 1 Arm A: Dose Finding Dexamethasone - Part 1 Arm B: Dose Finding CC-92480 - Part 1 Arm B: Dose Finding BMS-986158 - Part 1 Arm B: Dose Finding Dexamethasone - Part 1 Arm C: Dose Finding CC-92480 - Part 1 Arm C: Dose Finding Trametinib - Part 1 Arm C: Dose Finding Dexamethasone - Part 2 Arm D: Dose Expansion CC-92480 - Part 2 Arm D: Dose Expansion Dexamethasone - Part 2 Arm E: Dose Expansion CC-92480 - Part 2 Arm E: Dose Expansion Tazemetostat - Part 2 Arm E: Dose Expansion Dexamethasone - Part 2 Arm G: Dose Expansion CC-92480 - Part 2 Arm G: Dose Expansion Trametinib - Part 2 Arm G: Dose Expansion Dexamethasone -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years Establish dosing schedule of each combination for Part 2 Dose Expansion Up to approximately 2 years Establish recommended Phase 2 dose (RP2D) Up to approximately 2 years
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) Up to approximately 4 years Area under the concentration-time curve (AUC) Up to approximately 28 days Overall response rate (ORR) Up to approximately 4 years Very good partial response rate (VGPRR) Up to approximately 4 years Progression-free survival (PFS) Up to approximately 4 years Time to maximum plasma concentration (Tmax) Up to approximately 28 days Complete response rate (CRR) Up to approximately 4 years Time-to-response (TTR) Up to approximately 4 years Maximum observed plasma concentration (Cmax) Up to approximately 28 days
Trial Locations
- Locations (17)
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Alberta - Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
ICO - Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
NIHR UCLH Clinical Research Facility
🇬🇧London, United Kingdom
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Alberta Health Services AHS - Foothills Medical Centre FMC
🇨🇦Calgary, Alberta, Canada
University Health Network UHN - Princess Margaret Hospital PMH
🇨🇦Toronto, Ontario, Canada
Oslo University Hospital
🇳🇴Oslo, Norway
The Christie NHS Foundation Trust
🇬🇧Manchester, Greater Manchester, United Kingdom
Local Institution - 0001
🇬🇧Leicester, Leicestershire, United Kingdom
Local Institution - 0014
🇬🇧Liverpool, Merseyside, United Kingdom
Churchill Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom