• Completed

NCT00405756: Phase 3 - A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects

Updated: Sep 27

MM-015 study

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

Celgene Corporation


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

https://clinicaltrials.gov/ct2/show/NCT00405756

 

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

 

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

https://pubmed.ncbi.nlm.nih.gov/22571200/


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

https://pubmed.ncbi.nlm.nih.gov/23242595/


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

https://pubmed.ncbi.nlm.nih.gov/25840600/

 

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












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