Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of multiple myeloma
• * Newly diagnosed disease
• * Requires treatment, in the judgment of the treating physician
• * Not a candidate for (or patient declines) autologous stem cell transplantation
• Meets 1 of the following criteria:
• * Measurable disease, defined by any of the following:
• * Serum monoclonal protein ≥ 1 g/dL
• * Urine protein monoclonal light chain ≥ 200 mg/24 hours by electrophoresis
• * Measurable serum free light chains ≥ 10 mg/dL, kappa or lambda, AND κ/λ ratio is abnormal (if serum and urine are not measurable as defined above)
• * Evaluable disease, defined as monoclonal bone marrow plasmacytosis ≥ 30%
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-3
• Life expectancy \> 3 months
• ANC ≥ 1,500/mm³
• Bilirubin ≤ 2.0 mg/dL
• Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
• AST ≤ 3 times ULN
• Creatinine ≤ 3.0 mg/dL
• Platelet count ≥ 100,000/mm³
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 effective methods of contraception, including ≥ 1 highly effective method, ≥ 4 weeks before and during study treatment
• No uncontrolled infection
• No peripheral neuropathy ≥ grade 2
• No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance
• No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ
• \- Prior malignancy allowed if treated with curative intent and is free of disease for a period appropriate for that cancer
• No known hypersensitivity to thalidomide
• No known HIV positivity
• No infectious hepatitis A, B or C
• No history of deep vein thrombosis or other medical condition requiring the use of warfarin
• Able to take daily prophylactic acetylsalicylic acid (81 or 325 mg)
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• More than 4 weeks since prior radiotherapy for treatment of multiple myeloma
• No prior lenalidomide
• No other concurrent anticancer agents or treatments
• No concurrent steroids except prednisone ≤ 20 mg/day (or the equivalent) for concurrent illness or adrenal replacement therapy
• No other concurrent investigational therapy or agent for treatment of multiple myeloma
• No concurrent warfarin