NCT00551928

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

A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE, MELPHALAN AND PREDNISONE (MPR) Versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Fondazione EMN Italy Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of the combination of lenalidomide with low-dose melphalan versus high-dose melphalan in newly diagnosed, symptomatic MM patients.

Conditions

• Multiple Myeloma
• Newly Diagnosed Patients

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-06-01
• Primary completion: 2022-06-01
• Completion: 2024-07-01
• First posted: 2007-10-31
• Last updated: 2024-07-22

Locations

1 site across 1 country: Italy