Lenalidomide Melphalan and Prednisone Versus High Dose Melphalan in Newly Diagnosed Multiple Myeloma Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

June 30, 2022

Study Completion Date

July 1, 2024

Conditions
Multiple MyelomaNewly Diagnosed Patients
Interventions
DRUG

Melphalan

High dose Melphalan 200mg/sm with autologous stem cell support

DRUG

Lenalidomide

Six months of oral therapy with Lenalidomide 10mg/day given 21 days in every 28 days cycle with the combination ofMelphalan and steroids (day 22 to 28), for 6 cycles every 28 days.

DRUG

Prednisone

Given orally at the dose of 2 mg/Kg for 4 days followed by a 24 day rest period (days 5 to 28), for 6 cycles every 28 days

DRUG

Melphalan

Melphalan will be given orally at the dose of 0.18 mg/Kg for 4 days, followed by a 24 days rest period (day 5 to 28)for 6 cycles every 28 days

Trial Locations (1)

10126

Division of Hematology, AOU Città della Salute e della Scienza di Torino, Torino

All Listed Sponsors
lead

Fondazione EMN Italy Onlus

OTHER

NCT00551928 - Lenalidomide Melphalan and Prednisone Versus High Dose Melphalan in Newly Diagnosed Multiple Myeloma Patients | Biotech Hunter | Biotech Hunter