Untreated Myeloma without Intent for Autologous Transplant

Title:        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 (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant 
Sponsor:  Southwest Oncology Group 
Co-PI:  Bart Barlogie, MD, PhD 
Phase:  III 
Purpose: This study has the following objective:

  • 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. 

Eligibility:  Patients must have newly diagnosed multiple myeloma with measurable disease. Patients with non-secretory MM based upon standard M-component criteria (i.e., measurable serum/ urine M-component) are not eligible for this study. Exception: Patients with non-secretory MM will be eligible only if the baseline serum Freelite is elevated. 
Treatment:  Patients will proceed to the treatment prescribed for Arm 1 (lenalidomide/dexamethasone) or Arm 2 (bortezomib/lenalidomide/dexamethasone). For patients who will proceed to transplant, stem cell harvest is to be performed after the second cycle of treatment therapy for both Arms. 
Contact:  Nathan Petty
E-mail: pettynathanm@uams.edu
Phone: 501-526-6990 ext. 2435