50
Participants
Start Date
February 18, 2022
Primary Completion Date
March 1, 2026
Study Completion Date
March 1, 2031
Isatuximab
Pharmaceutical form: Solution for infusion Route of administration: Intravenous Isatuximab:10 mg/kg intravenous or 1400 mg subcutaneous (SC) via on-body delivery system (OBDS) will be administered in cycles 1-24.
Lenalidomide
"Pharmaceutical form: Capsule for oral use, Route of administration: Oral Lenalidomide capsule will be given oral, the dose will be adjusted according to glomerular filtration rate (GFR): 15 mg daily if GFR \> 60 mL/min, 5 mg daily if GFR 30-60 mL/min, 2.5 mg daily if GFR \< 30 mL/min. Note that dialysis-dependence comprises an exclusion criterion for this study.~Lenalidomide will be continued until disease progression, excessive toxicity or death."
Dexamethasone
Pharmaceutical form: Tablet for oral use, Route of administration: Oral Dexamethasone tablet will be given oral: 20 mg given on days 1, 8, 15 and 22 of cycles 1-8. Administration may continue beyond cycle 8, if needed, for the prevention of infusion reactions.
RECRUITING
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, Chapel Hill
RECRUITING
Duke Comprehensive Cancer Center, Durham
RECRUITING
Levine Cancer Institute, Charlotte
RECRUITING
Novant Health New Hanover Regional Medical Center, Wilmington
RECRUITING
The Ohio State University Comprehensive Cancer Center, Columbus
Genzyme, a Sanofi Company
INDUSTRY
UNC Lineberger Comprehensive Cancer Center
OTHER