90
Participants
Start Date
September 30, 2022
Primary Completion Date
October 31, 2026
Study Completion Date
October 31, 2026
Isatuximab
Isatuximab treatment at a dose of 10 mg/kg by intravenous route. The first injection of isatuximab will be performed at randomization (month 6 +/- 2 days). A second injection may be performed at day 15 if the reticulocytes \<10 G / L, and a third at day 29 if reticulocytes \<10 G / L. Patients will be assessed on day 1, day 15, day 29, day 45, 2 months, 3 months, 6 months and 9 months after randomization.
Assistance Publique - Hôpitaux de Paris
OTHER