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

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