Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed multiple myeloma by one of the following:
• •* Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
• •* Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis
• •* Bone marrow \< 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein criteria
• •Ineligible for stem cell transplantation due to any of the following:
• •* Advanced age
• •* Comorbid illness
• •* Patient preference
• •Previously untreated disease
• •Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis
• •* No nonsecretory myeloma
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy ≥ 12 months
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 150,000/mm\^3
• •Creatinine ≤ 3 times upper limit of normal (ULN)
• •Bilirubin ≤ 1.5 times ULN
• •AST and/or ALT ≤ 1.5 times ULN
• •Alkaline phosphatase ≤ 1.5 times ULN
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use 2 methods of effective contraception during and for 4 weeks after completion of study treatment
• •No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancer of the cervix
• •No hypersensitivity to thalidomide or its components, including the development of a desquamating rash
• •No other serious illness or medical condition that would preclude study participation
• •No history of significant neurologic or psychiatric disorder that would preclude informed consent
• •No known HIV positivity
• •No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following:
• •* Significant cardiac event (including symptomatic heart failure or angina) within 3 months prior to randomization
• •* Any cardiac disease that increases risk for ventricular arrhythmia
• •* History of ventricular arrhythmia that was symptomatic or required treatment, including any of the following:
• •* Multifocal premature ventricular contractions
• •* Bigeminy
• •* Trigeminy
• •* Ventricular tachycardia/fibrillation/flutter/arrhythmia NOS
• •PRIOR CONCURRENT THERAPY:
• •No prior chemotherapy or corticosteroids for the treatment of multiple myeloma
• •* Prior corticosteroids for the treatment of hypercalcemia or spinal cord compression allowed provided maximum levels have not been reached (i.e.,\< 120 mg for dexamethasone or \< 792 mg for prednisone)
• •Prior radiotherapy to single sites for pain control or local plasmacytoma allowed
• •Prior or concurrent bisphosphonates allowed
• •At least 28 days since prior investigational anticancer agents or therapy
• •No concurrent corticosteroids above physiologic replacement doses
• •Concurrent radiotherapy to sites of active myeloma with pain or neurologic compromise allowed
• •No concurrent filgrastim (G-CSF) on day 1 of course 1
• •No other concurrent anticancer therapy
• •No other concurrent investigational therapy