NCTN: An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) vs Melphalan, Prednisone and Lenalidomide (Revlimid) (MPR) in Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy (E1A06)
Study ID: E1A06
NCT Number: NCT00602641
ECOG-ACRIN Cancer Research Group
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) vs Melphalan, Prednisone and Lenalidomide (Revlimid) (MPR) in Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy (E1A06)
Trial Description:
This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.
Clinical data presented in the following publication(s):
- PMID 26157076
Disease type(s): Hematopoietic Neoplasm/Myeloma - Myeloma
Clinical Dataset(s) included:
- NCT00602641-D1 (PMID 26157076): There are three datasets for E1A06's primary publication 26157076 (-D1 through -D3). This dataset contains baseline characteristics, overall survival, progression-free survival, stratification, response, treatment and maintenance duration, and quality of life assessment data. It includes all randomized patients according to assigned treatment. Unless otherwise indicated, blank fields indicate missing values.
- NCT00602641-D2 (PMID 26157076): There are three datasets for E1A06's primary publication 26157076 (-D1 through -D3). This dataset contains dosing information by visit. Unless otherwise indicated, blank fields indicate missing values.
- NCT00602641-D3 (PMID 26157076): There are three datasets for E1A06's primary publication 26157076 (-D1 through -D3). This dataset contains data for adverse events analyses and tables. Unless otherwise indicated, blank fields indicate missing values.
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Interventional
- Archive: The database of Genotypes and Phenotypes (dbGaP)