Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diagnosed, Previously Untreated Multiple Myeloma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of multiple myeloma meeting 1 of the following criteria:
• * Monoclonal immunoglobulin spike on serum electrophoresis (IgG \> 3.5 g/dL or IgA \> 2.0 g/dL) and kappa or lambda light chain excretion \> 1 g/day by 24-hour urine protein electrophoresis AND meets any of the following criteria:
• * Bone marrow plasmacytosis (10-30% plasma cells)
• * Lytic bone lesions
• * Monoclonal immunoglobulin of lesser magnitude present and bone marrow plasmacytosis (10-30% plasma cells) AND meets any of the following criteria:
• * Lytic bone lesions
• * IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
• * Bone marrow plasmacytosis (\> 30% plasma cells) or plasmacytoma on tissue biopsy AND meets any of the following criteria:
• * Monoclonal immunoglobulin of lesser magnitude present
• * Lytic bone lesions
• * IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
• * FreeLite testing abnormal and kappa:lambda light chain ratio abnormal
• Symptomatic disease requiring treatment
• * Documented related organ or tissue involvement, if present
• Measurable disease, defined as 1 of the following:
• * Monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/day
• * Abnormal FreeLite testing (for nonsecretors)
• * Patients with nonsecretory disease must meet either of the following criteria for measurability:
• * Has measurable protein by FreeLite testing
• * Untreated soft tissue plasmacytoma and/or evaluable disease in bone marrow
• Newly diagnosed, previously untreated disease
• No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\], and skin changes)
• No plasma cell leukemia
• PATIENT CHARACTERISTICS:
• Karnofsky performance status 50-100%
• Platelet count ≥ 100,000/mm³ (≥ 50,000/mm³ if bone marrow is extensively infiltrated)
• * Extensive infiltration is defined as \> 50% myeloma cells or plasma cells
• Hemoglobin ≥ 8.5 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• AST and ALT ≤ 2 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN (unless clearly related to the disease)
• Creatinine clearance ≥ 20 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 methods of effective contraception ≥ 4 weeks prior to beginning treatment, during, and for ≥ 4 weeks after completion of study treatment
• No impaired kidney function requiring dialysis
• No uncontrolled infection
• No HIV positivity
• No known active hepatitis B or C
• No cardiovascular disease including, but not limited to, any of the following:
• * Myocardial infarction within the past 6 months
• * New York Heart Association class II-IV heart failure
• * Uncontrolled angina
• * Severe uncontrolled ventricular arrhythmias
• * Clinically significant pericardial disease
• * Acute ischemic or active conduction system abnormalities by EKG
• No history of allergic reactions to compounds containing mannitol, bortezomib, or cyclophosphamide
• No second malignancy requiring concurrent treatment
• No other serious medical or psychiatric illness that would preclude study compliance
• No peripheral neuropathy ≥ grade 1
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy, immunotherapy, vaccine therapy, therapeutic doses of steroids, or other agents for the treatment of active myeloma
• * Drugs given to prevent onset of myeloma allowed
• * Bisphosphonates for hypercalcemia or short course corticosteroids for hypercalcemia or cord compromise allowed
• Prior local radiotherapy with or without a brief exposure to steroids allowed
• More than 4 weeks since prior and no concurrent radiotherapy
• * Spot radiotherapy to ≤ 3 vertebrae allowed
• No concurrent steroids at \> 10 mg of prednisone daily (or the equivalent) for other medical conditions (e.g., asthma, systemic lupus erythematosus, or rheumatoid arthritis)
• No other concurrent chemotherapy or investigational agents
• Concurrent daily acetylsalicylic acid required during course 4-6 of study treatment