NCT00405756: Phase 3 - A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects
Updated: Sep 27, 2022
MM-015 study
NCT00405756
A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.
The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.
Sponsor
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT00405756
Official Title: A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In Subjects With Newly Diagnosed Multiple
First Posted : November 30, 2006
Drug: Lenalidomide: Double-blind Induction
Drug: Melphalan
Drug: Prednisone
Drug: Aspirin
Drug: Placebo
Drug: Lenalidomide: Double-blind Maintenance
Drug: Lenalidomide: Open-label
Continuous lenalidomide treatment for newly diagnosed multiple myeloma
Conclusions: MPR-R significantly prolonged progression-free survival in patients with newly diagnosed multiple myeloma who were ineligible for transplantation, with the greatest benefit observed in patients 65 to 75 years of age. (Funded by Celgene; MM-015 ClinicalTrials.gov number,
N Engl J Med 2012
Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial
Haematologica 2013
Impact of maintenance therapy on subsequent treatment in patients with newly diagnosed multiple myeloma: use of "progression-free survival 2" as a clinical trial end-point
Haematologica 2015
Locations
Australia, Queensland
Australia, South Australia
Australia
Europe
United Kingdom
Austria
Belarus
Belgium
Czech Republic
Denmark
France
Georgia
Germany
Greece
Ireland
Italy
Netherlands
Poland
Spain
Sweden
Switzerland
Turkey
Ukraine
Asia
Israel
Russian Federation