S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of multiple myeloma (MM)
• * Active disease
• Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included autologous or allogeneic stem cell transplantation
• * Relapse is defined as the occurrence of any of the following during or after prior treatment:
• * Myeloma protein level increase by \> 100% from the lowest previously recorded level
• * Myeloma protein level increase above the defined response criteria for partial remission
• * Reappearance of any myeloma peak that had disappeared during the prior treatment
• * Increase in the size and number of lytic bone lesions and/or focal lesions by x-ray, MRI, positron emission tomography, and/or CT scan
• * Refractory disease is defined as no response (i.e., not achieving complete remission, remission, or partial remission) to prior therapy
• Measurable disease
• No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) syndrome
• Must be registered on protocol SWOG-S0334
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• Zubrod 0-2 (unless due to bone pain)
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count \> 1,000/mm\^3
• Platelet count \> 50,000/mm\^3
• Hepatic
• AST or ALT ≤ 3 times upper limit of normal (ULN)
• Bilirubin ≤ 3 times ULN
• Renal
• Creatinine clearance \> 30 mL/min
• Cardiovascular
• No New York Heart Association class III or IV congestive heart failure
• No myocardial infarction within the past 6 months
• No poorly controlled hypertension
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use effective double method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for 4 weeks after completion of study treatment for male patients)
• No blood, ova, or sperm donation during study treatment
• No active infection requiring antibiotics
• No neurotoxicity ≥ grade 2
• No diabetes mellitus
• No other serious medical or psychiatric illness that would preclude study treatment
• No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• See Disease Characteristics
• Chemotherapy
• At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered
• Endocrine therapy
• Not specified
• Radiotherapy
• At least 14 days since prior radiotherapy and recovered
• Surgery
• Not specified
• Other
• No prior bortezomib alone or combined with thalidomide
• Concurrent participation on protocol SWOG-S0309 allowed