Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

DISEASE CHARACTERISTICS:

• Newly diagnosed multiple myeloma, meeting the following criteria:
• Symptomatic disease
• Previously untreated disease
• Measurable or evaluable disease, defined by ≥ 1 of the following:
• Serum monoclonal protein ≥ 1.0 g/dL
• Monoclonal protein > 200 mg by 24-hour urine electrophoresis
• Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa:lambda free light chain ratio
• Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
• Measurable soft tissue plasmacytoma, not previously radiated
• No monoclonal gammopathy of unknown significance or asymptomatic myeloma

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 (PS 3 allowed if secondary to pain)
• ANC ≥ 1,500/μL
• Platelet count ≥ 75,000/μL
• Creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 effective forms of contraception 28 days prior to, during and 28 days after study treatment
• Registered into the RevAssist® program and willing to comply with program requirements
• Able to take prophylactic aspirin (325 mg/day) or warfarin or low molecular weight heparin
• Willing to provide mandatory blood and bone marrow samples
• Willing to return for follow up
• No uncontrolled infection
• No NYHA class III or IV heart failure
• No active deep vein thrombosis that has not been therapeutically anticoagulated
• No known hypersensitivity to thalidomide
• No known HIV positivity
• No known hepatitis type A, B, or C infection
• No other prior active malignancy within the past 2 years, except currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
• No development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs

PRIOR CONCURRENT THERAPY:

• At least 3 weeks since prior radiotherapy for solitary plasmacytoma
• More than 28 days since other prior experimental drug or therapy
• Prior clarithromycin, DHEA, anakinra, pamidronate, or zoledronic acid allowed
• No prior lenalidomide
• No prior cytotoxic chemotherapy
• No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease
• Prior corticosteroid for nonmalignant disease allowed
• Concurrent corticosteroids allowed (≤ 20 mg/day of prednisone or equivalent)
• Concurrent palliative radiotherapy for bone pain or fracture allowed
• No other concurrent anticancer agents or treatments