- Completed
NCT00424047: Phase 3 - CC-5013 (lenalidomide) Dex Vs Dex Alone Previously Treated Multiple Myeloma
Updated: Sep 27, 2022
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
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:
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