Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma

Inclusion Criteria

• Patients must not have received prior myeloma specific therapy (chemotherapy, radiotherapy, or biologic therapy) other than bisphosphonate therapy
• Patients may have received radiation of plasmacytoma (for example, solitary plasmacytoma); the last such treatment must have occurred >= 4 weeks prior to registration
• Patients must be recently diagnosed with symptomatic multiple myeloma confirmed by meeting one or more of the following criteria (obtained = = 1 g/dl (measurable disease), or
• Monoclonal light chain in the urine protein electrophoresis >= 200 mg/24 hours (measurable disease), or
• Bone marrow plasmacytosis >= 30% without either of the values in above (evaluable disease)
• Patients must meet one or more of the following (all tests must be been drawn = = 5.5 mcg/mL, or
• PCLI >= 1, or
• Deletion 13 by cytogenetics
• Platelet count >= 20, 000/mm^3, with or without transfusion support
• Hemoglobin >= 7.0 g/dL, with or without transfusion support
• Absolute neutrophil count (ANC) >= 500/mm^3 without growth factor support
• Direct bilirubin within = = 20 mL/minute
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2; exception: PS = 3 if secondary to acute bone event (fracture)
• Patients may not receive concurrent chemotherapy, radiotherapy or biologic therapy while on study; the exception for corticosteroids is made for those taking chronic corticosteroids for disorders other than myeloma, such as rheumatoid arthritis, adrenal insufficiency, etc.
• NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
• Patients must not have a history of allergic reaction attributable to compounds containing boron or mannitol
• Patient must not have a peripheral neuropathy > grade 1, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 3.0):
• Grade 2: Objective sensory (or motor) loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADL)
• Grade 3: Sensory (or motor) loss or paresthesia interfering with ADL
• Grade 4: Permanent sensory (or motor) loss that interferes with function
• Patient must be capable of understanding the investigational nature, potential risks and benefits of the study
• Patient must have adequate cardiac function; patient must not have:
• History of a myocardial infarction within 6 months of enrollment
• New York Heart Association (NYHA) class III or IV heart failure
• Uncontrolled angina or electrocardiographic evidence of acute ischemia
• Severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of active conduction system abnormalities
• Cardiac amyloidosis
• Patient must not have any other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
• Patient must not have poorly controlled hypertension
• Women must not be pregnant or breast feeding; all females of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception