Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

Inclusion Criteria:

• Newly diagnosed multiple myeloma (MM)

  • Stage I, II, or III disease by the New International Staging System
• Measurable disease

• Nonsecretory MM based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is elevated

  • Serum Freelite must be drawn
  • No freelite chains
• Must be offered participation in the Myeloma Specimen Repository for banking and future research, and in the Gene Expression Profiling (GEP) molecular studies for the evaluation of genetic polymorphisms
• Must have baseline skeletal survey, including lateral skull, anteroposterior (AP) pelvis and posteroanterior (PA) chest within 28 days prior to study entry
• Institutions must submit a local cytogenetics report and FISH analysis prior to study entry
• Zubrod performance status 0-3
• Platelet count ≥ 80,000/mm³*
• ANC ≥ 1,000/mm³*
• Hemoglobin ≥ 9.0 g/dL* (including patients who have been transfused or treated with epoetin)
• Creatinine clearance > 30 cc/min
• FEV_1 and FVC ≥ 50% of predicted**
• DLCO ≥ 50% of predicted**
• No uncontrolled, active infection requiring IV antibiotics
• No NYHA class III-IV heart failure
• No myocardial infarction within the past 6 months
• No history of treatment for clinically significant ventricular cardiac arrhythmias
• No poorly controlled hypertension
• No poorly controlled diabetes mellitus
• No chronic obstructive or chronic restrictive pulmonary disease
• Must have undergone an EKG within the past month
• No psychiatric illness that could potentially interfere with the completion of study treatment
• No history of cerebral vascular accident with persistent neurologic deficits
• No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
• No hepatitis B or C positivity
• HIV negative***
• Not pregnant or nursing
• Negative pregnancy test

• Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment

  • Female patients must use 2 reliable forms of contraception simultaneously
  • Male patients must use effective barrier contraception
• Patients with pathologic fractures, pneumonia at diagnosis, or symptomatic hyperviscosity syndrome must have these conditions attended to prior to study entry (i.e., intramedullary rod, IV antibiotics, or plasmapheresis)
• Patients must have baseline skeletal survey that include lateral skull, anteroposterior (AP) pelvis, and posteroanterior (PA) chest within the past 28 days
• No prior chemotherapy for this disease
• No prior radiotherapy to a large area of the pelvis (i.e., more than half of the pelvis)
• No prior bortezomib or lenalidomide
• Prior steroid treatment allowed provided treatment was no more than 2 weeks in duration
• Must be able to take concurrent aspirin 325 mg daily (or enoxaparin 40 mg subcutaneously daily if allergic to aspirin) as prophylactic coagulation