||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
||Southwest Oncology Group
||Bart Barlogie, MD, PhD
||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.
||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.
||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.
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