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NCT00098475: Phase 3: Lenalidomide and Dexamethasone With or Without Thalidomide in Multiple Myeloma

Updated: Jul 16


ECOG-ACRIN Cancer Research Group

ECOG E4A03

NCT00098475: Phase 3: Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma


 ECOG E4A03

This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

 

Active Comparator: Arm I (lenalidomide, dexamethasone)

Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.


Experimental: Arm II (lenalidomide, low-dose dexamethasone)

Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.


Active Comparator: Arm III (thalidomide, dexamethasone)

Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20


Experimental: Arm IV (thalidomide, low-dose dexamethasone)

Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

 

Sponsor:

National Cancer Institute (NCI)

 

ClinicalTrials.gov Identifier: NCT00098475

Official Title: A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders

First Posted : December 8, 2004


Click here for details on ClinicalTrials.gov

 

Drug: Dexamethasone

Other: Laboratory Biomarker Analysis

Drug: Lenalidomide

Drug: Thalidomide

 

ECOG-ACRIN Cancer Research Group

 

Lancet Oncol; 2010

Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial

Lenalidomide plus low-dose dexamethasone is associated with better short-term overall survival and with lower toxicity than lenalidomide plus high-dose dexamethasone in patients with newly diagnosed myeloma.

https://pubmed.ncbi.nlm.nih.gov/19853510/


Blood; 2011

Impact of gene expression profiling-based risk stratification in patients with myeloma receiving initial therapy with lenalidomide and dexamethasone

https://pubmed.ncbi.nlm.nih.gov/21860025/

 

Locations

United States, Alabama

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