50
Participants
Start Date
July 30, 2019
Primary Completion Date
February 8, 2022
Study Completion Date
November 8, 2027
Carfilzomib
Induction 6 cycles 20/36 mg/m² on days 1, 2, 8, 9, 15, 16 (20 mg/m² on D1 and 2 cycle 1 only) Consolidation 4 cycles Carfilzomib 20 or 36 mg/m² on days 1, 2, 8, 9, 15, 16 (20 mg/m² on D1 and 2 first cycle only)
Daratumumab
induction: 6 cycles Daratumumab 8/16mg/kg IV on Days 1, 8, 15, 22 for the first two cycle 2 and on days 1 and 15 for cycles 3 to 6. (8mg/kg on D1 \& D2 cycle 1 only) Consolidation: daratumumab 4 cycles 16mg/kg IV Day 1, Day 15 Maintenance Daratumumab 16mg/kg IV once every 8 weeks for 2 years (or until documented disease progression)
Lenalidomide
induction: 6 cycles Lenalidomide 25 mg/day from day 1 to day 21 Consolidation: 4 cycles 15 mg/day from Day 1 to Day 21 (first cycle ) 25 mg/day from Day 1 to Day 21 (in the following cycle) Maintenance therapy 10mg/day, Day 1 to 21, for 2 years (or until documented disease progression)
Dexamethasone
induction 6 cycles 20 mg/day on days 1-2, 8-9, 15-16 and 22-23 Consolidation 4 cycles 40 mg/Day on Days 1, 8, 15 and 22
CHU de Nantes, Nantes
CHU Caen, Caen
CHRU Dijon, Dijon
CHRU - Hôpital A.Michallon, Grenoble
CHD Vendée, La Roche-sur-Yon
CHRU - Hôpital Claude Huriez, Lille
CH de Lyon Sud, Lyon
CHRU Hôpital du Haut Lévêque, Pessac
CHRU - Hôpital de Pontchaillou, Rennes
CHU Toulouse, Toulouse
CHRU Bretonneau, Tours
CHRU - Hôpitaux de Brabois, Vandœuvre-lès-Nancy
Nantes University Hospital
OTHER