An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 30, 2019

Primary Completion Date

February 8, 2022

Study Completion Date

November 8, 2027

Conditions
Multiple Myeloma
Interventions
DRUG

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)

DRUG

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)

DRUG

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)

DRUG

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

Trial Locations (12)

44000

CHU de Nantes, Nantes

Unknown

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

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT03606577 - An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients | Biotech Hunter | Biotech Hunter