54
Participants
Start Date
April 1, 2022
Primary Completion Date
June 24, 2025
Study Completion Date
December 15, 2027
Isatuximab
Isatuximab (IV): 10 mg/kg on Days 1, 8, 15, 22, 29 in Cycle 1; from Cycle 2 onwards, it will be given on Days 1, 15, 29.
Bortezomib
Bortezomib (SQ): 1.3 mg/m² on Days 1, 4, 8, 11, 22, 25, 29, and 32.
Lenalidomide
Lenalidomide (PO): 25 mg/day (10 mg/day for patients with creatinine clearance \[CrCl\] ≥30 to \<60 mL/min) from Day 1 to Day 14 and from Day 22 to Day 35 of each cycle.
Dexamethasone (IV)
Dexamethasone (IV on the days of Isatuximab and PO on other days): 20 mg/day on Days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23, 25, 26, 29, 30, 32, and 33. If patients are ≥75 years old, dexamethasone will be administered on Days 1, 4, 8, 11, 15, 16, 22, 25, 29 and 32.
Aarhus University Hospital, Aarhus
Beaumont Hospital, Dublin
Mater Misericordiae University Hospital, Dublin
St James's Hospital, Dublin
University Hospital Waterford, Waterford
Collaborators (1)
Sanofi
INDUSTRY
Dana-Farber Cancer Institute
OTHER
Cancer Trials Ireland
NETWORK