A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
Treatment Location: N/A
Primary Objective The primary objective of this study is to compare progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone. Secondary Objectives a. Assess response using the new international response criteria. b. To bank specimens for future translational medicine research. c. Follow patients to assess overall survival and other long-term outcomes stratified by intent to transplant at progression. Molecular Testing Objectives a. To evaluate custom and genome-wide single nucleotide polymorphisms in correlation with biology, prognosis and outcome for each treatment regimen. To verify the findings recently obtained with the custom BOAC SNP chip on TT2 data with respect to bone disease in the cooperative group setting. b. To use basline gene expression profiling as a tool to evaluate the biology, prognostic and risk factors, and response to therapy for both treatment regimens combined. To validate John Shaughnessy's 70 gene model developed for Total Therapy 2 (TT2) in the cooperative group setting.
IRB Review and Approval Date: 09/18/2009
Recruitment Status: Closed
Projected Accrual: N/A