A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-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

Pts must have newly diagnosed multiple myeloma (Section 4.1) with measurable disease within 28 days prior to reg. Pts with non-secretory MM are not eligible unless baseline serum freelite is elevated (must be serum Freelite, not freelight chains). Pts must not have prior chemotherapy or radiotherapy to more than half of pelvis. Prior steroid treatment allowed if it was less than 2 wks duration. No prior bortezomib or lenalidomide treatment allowed. Pts must be at least 18 yrs of age. Pts must have Zubrod PS 0-3. Pts must have adequate marrow function (Section 5.5). Pts must be offered participation in Myeloma Specimen Repository. Pts must have baseline skeletal survey. Institutions must submit local cytogenetics analysis and FISH report. Pts must be offered participation in GEP studies. Pts must be treated for pathologic fractures, pneumonia or symptomatic hyperviscosity prior to reg if present at diagnosis. Pts must have creatinine clearance > 30 cc/min within 28 days prior to reg. Pts must not have uncontrolled, active infection requiring IV antibiotics, NYHA Class III or IV heart failure, myocardial infarction within the last 6 months, history of treatment for clinically significant ventricular cardiac arrhythmias, poorly controlled hypertension or poorly controlled diabetes mellitus. Pts must undergo EKG within 28 days prior to reg. Patients must have negative Hep B, Hep C and HIV test within 28 days prior to reg. Treatment-sensitive HIV infection pts will be eligible if immunological and virologic indices are indicative of favorable long-term survival on basis of HIV infection and life expectancy is limited by MM, not HIV. Pts must not have history of cerebral vascular accident with persistent neurologic deficits. Pts must be able to take aspirin 325 mg daily (or enoxaparin 40 mg SQ daily), unless on anticoagulation therapy such as coumadin or heparin (as these pts will not receive aspirin). Females of childbearing potential must have negative serum or urine pregnancy test with sensitivity of at least 25 mIU/mL 10-14 days prior to and again within 24 hours prior to starting lenalidomide; must agree to abstinence from heterosexual intercourse or begin two acceptable methods of birth control at least 4 weeks before starting lenalidomide. Men must agree not to father a child and to use a condom if he or partner is of child bearing potential. Pts must be counseled a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Pts must not have prior malignancy except adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the pt has been disease-free for five yrs.