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
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).
Arms & interventions
- DrugCC-92480
Specified dose on specified days
- DrugTazemetostat
Specified dose on specified days
- DrugBMS-986158
Specified dose on specified days
- DrugTrametinib
Specified dose on specified days
- DrugDexamethasone
Specified dose on specified days
Outcome measures
Primary
Number of participants with adverse events (AEs)
Time frame: From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years
Number of participants with Serious AEs
Time frame: Up to approximately 4 years
Number of participants with AEs meeting protocol-defined DLT criteria
Time frame: Up to approximately 4 years
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 4 years
Number of deaths
Time frame: Up to approximately 4 years
Establish recommended Phase 2 dose (RP2D)
Time frame: Up to approximately 2 years
Establish dosing schedule of each combination for Part 2 Dose Expansion
Time frame: Up to approximately 2 years
Secondary
Overall response rate (ORR)
Time frame: Up to approximately 4 years
Very good partial response rate (VGPRR)
Time frame: Up to approximately 4 years
Complete response rate (CRR)
Time frame: Up to approximately 4 years
Time-to-response (TTR)
Time frame: Up to approximately 4 years
Duration of response (DOR)
Time frame: Up to approximately 4 years
Progression-free survival (PFS)
Time frame: Up to approximately 4 years
Maximum observed plasma concentration (Cmax)
Time frame: Up to approximately 28 days
Time to maximum plasma concentration (Tmax)
Time frame: Up to approximately 28 days
Area under the concentration-time curve (AUC)
Time frame: Up to approximately 28 days
Terminal Half-Life (T-Half)
Time frame: Up to approximately 28 days
Apparent total body clearance (CLT/F)
Time frame: Up to approximately 28 days
Apparent volume of distribution (Vz/F)
Time frame: Up to approximately 28 days
Eligibility criteria
Study locations (5)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35249
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
Memorial Sloan Kettering Cancer Center
New York, New York, 10021