Bortezomib and Dexamethasone in Treating Patients With Multiple Myeloma That Has Relapsed or Has Not Responded to Treatment

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Diagnosis of multiple myeloma
• •* Refractory or relapsed disease meeting the following criteria:
• •* Primary refractory disease and first-line relapsing disease
• •* Progressive disease after last therapy
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy \> 3 months
• •Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ for patients with significant bone marrow involvement)
• •* Transfusions allowed
• •Hemoglobin ≥ 7.5 g/dL
• •Absolute neutrophil count ≥ 750/mm³
• •Serum calcium \< 14 mg/dL
• •AST and ALT \< 2.5 times upper limit of normal
• •Creatinine clearance ≥ 30 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No peripheral neuropathy ≥ grade 2 within the past 14 days
• •No hypersensitivity to boron or mannitol
• •No cardiovascular complications, including any of the following:
• •* Myocardial infarction within the past 6 months
• •* New York Heart Association class III-IV heart failure
• •* Uncontrolled angina
• •* Ventricular arrhythmias
• •* Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• •* Cardiac amyloidosis
• •No other cancer or treatment for cancer other than basal cell cancer of the skin within the past 5 years
• •No poorly controlled chronic diseases (e.g., diabetes mellitus or hypertension)
• •No HIV positivity
• •No hepatitis B surface antigen or active hepatitis C infection
• •No active systemic infection requiring therapy
• •No serious medical or psychiatric illness that would interfere with study participation
• •PRIOR CONCURRENT THERAPY:
• •No plasmapheresis within the past 4 weeks
• •No major surgery within the past 4 weeks
• •No prior bortezomib
• •No chemotherapy (e.g., clarithromycin) within the past 4 weeks
• •No radiotherapy within the past 3 weeks
• •No corticosteroids (\> 10 mg/day of prednisone or equivalent) within the past 3 weeks
• •No other immunotherapy within the past 8 weeks
• •No other investigational drugs within the past 14 days
• •No concurrent participation in other clinical research studies