Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

January 28, 2022

Study Completion Date

January 22, 2024

Conditions
Plasma Cell Myeloma
Interventions
DRUG

lenalidomide

Pharmaceutical form: tablet Route of administration: oral

DRUG

bortezomib

Pharmaceutical form: lyophilized powder for subcutaneous injection Route of administration: subcutaneous

DRUG

cyclophosphamide

Pharmaceutical form: tablet Route of administration: oral

DRUG

dexamethasone

Pharmaceutical form: tablet or solution for infusion Route of administration: oral or intravenous

DRUG

isatuximab SAR650984

Pharmaceutical form: solution for infusion Route of administration: intravenous

Trial Locations (12)

10126

Investigational Site Number : 380001, Torino

12200

Investigational Site Number : 276003, Berlin

20132

Investigational Site Number : 380003, Milan

28041

Investigational Site Number : 724003, Madrid

31008

Investigational Site Number : 724001, Pamplona

31059

Investigational Site Number : 250001, Toulouse

37007

Investigational Site Number : 724002, Salamanca

39008

Investigational Site Number : 724004, Santander

44093

Investigational Site Number : 250002, Nantes

69495

Investigational Site Number : 250003, Pierre-Bénite

04103

Investigational Site Number : 276002, Leipzig

00161

Investigational Site Number : 380002, Roma

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY