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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
RECRUITINGNumber 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
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
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CONTACT
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Specified dose on specified days
Specified dose on specified days
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGJohn Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGAlberta Health Services AHS - Foothills Medical Centre FMC
Calgary, Alberta, Canada
RECRUITINGUniversity of Alberta - Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGUniversity Health Network UHN - Princess Margaret Hospital PMH
Toronto, Ontario, Canada
RECRUITINGOslo University Hospital
Oslo, Outside US and Canada, Norway
RECRUITINGICO - Hospital Germans Trias i Pujol
Barcelona, Spain
RECRUITING...and 7 more locations
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