NCT01091831

Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) Versus Melphalan (200 mg/m2) Followed By Autologous Stem Cell Transplant (ASCT) In Newly Diagnosed Multiple Myeloma Subjects

A Phase 3, Multicentre, Randomized, Controlled Study to Determine the Efficacy and Safety of Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) 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: 389 (actual)
• Sponsor: Fondazione EMN Italy Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open label study designed to compare the efficacy and safety of lenalidomide with low-dose alkylating agents versus high-dose melphalan followed by stem cell support in newly diagnosed symptomatic MM patients who are 65 years of age or younger.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide will be given orally at the dose of 300 mg/m2 on days 1, 8, 15 for 6 cycles every 28 days
DRUG	Lenalidomide	Lenalidomide will be given orally at the dose of 25 mg/d for 21 days followed by a 7 days rest period (day 22 to 28)for 6 cycles every 28 days
DRUG	Dexamethasone	Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15, 22 for 6 cycles every 28 days
DRUG	Melphalan	Melphalan will be given iv at the dose of 200 mg/m2 for 1 day followed by stem cell support. The second MEL200 was performed 120 days after the first if ≤ PR was achieved after the 1st MEL200.

Timeline

• Start date: 2009-07-01
• Primary completion: 2021-09-01
• Completion: 2024-07-01
• First posted: 2010-03-24
• Last updated: 2024-11-06

Locations

1 site across 1 country: Italy