• Completed

NCT00424047: Phase 3 - CC-5013 (lenalidomide) Dex Vs Dex Alone Previously Treated Multiple Myeloma

Updated: Sep 27

Multiple Myeloma (010)

MM-010

NCT00424047: A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma


To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma.


Sponsor

Celgene

 

ClinicalTrials.gov Identifier: NCT00424047

Official Title: The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

Click here for details on Clinicaltrials.gov

 

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22

https://pubmed.ncbi.nlm.nih.gov/18032763/


Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22

https://pubmed.ncbi.nlm.nih.gov/18032762/



Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone.

Clin Lymphoma Myeloma Leuk. 2011 Feb;11

https://pubmed.ncbi.nlm.nih.gov/21273172/


Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone.

J Clin Oncol. 2010 Jan

https://pubmed.ncbi.nlm.nih.gov/19901114/


Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure.

Blood. 2008 Dec

https://pubmed.ncbi.nlm.nih.gov/18799726/

 

Related Study:

MM-009: NCT00056160 : Phase 3 - CC-5013 (lenalidomide) Dex Vs Dex Alone Previously Treated Multiple Myeloma


Two identically designed, multicenter, double-blind, phase III clinical trials (MM-009 and MM-010) were conducted in Europe and the United States to assess the effect of lenalidomide in combination with dexamethasone versus dexamethasone plus placebo

 

Locations

Australia, New South Wales

Australia, Victoria

Australia

Europe

Asia

Austria

Belgium

France

Germany

Greece

Ireland

Israel

Italy

Poland

Sweden

Switzerland

Ukraine

United Kingdom




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