Bortezomib, Ascorbic Acid, and Melphalan in Treating Patients With Newly Diagnosed Multiple Myeloma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Newly diagnosed symptomatic multiple myeloma based on the following criteria:
• * Durie-Salmon staging
• * Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
• Symptomatic disease
• No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\], and skin changes)
• No plasma cell leukemia
• PATIENT CHARACTERISTICS:
• Karnofsky performance status 60-100%
• Life expectancy \> 3 months
• Platelet count ≥ 50,000/mm³ (30,000/mm³ if the bone marrow is extensively infiltrated)
• Hemoglobin ≥ 8.0 g/dL
• Absolute neutrophil count ≥ 1,000/mm³
• Creatinine ≤ 3 mg/dL
• Sodium \> 130 mmol/L corrected
• AST and ALT ≤ 3 times upper limit of normal (ULN)
• Bilirubin ≤ 2 times ULN unless clearly related to the disease
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Any ECG abnormality has to be documented by the investigator as not medically relevant
• No electrocardiographic evidence of acute ischemia or new conduction system abnormalities
• No myocardial infarction or EKG evidence of infarction within the past 6 months
• No active infection
• No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL \[3.5 mmol/L\])
• No New York Heart Association class III or IV heart failure
• No uncontrolled angina
• No severe uncontrolled ventricular arrhythmias
• No active conduction system abnormalities
• No poorly controlled hypertension
• No diabetes mellitus
• No known HIV infection
• No known active hepatitis B or C viral infection
• No history of grand mal seizures
• No history of allergic reaction to compounds of similar chemical or biological composition to melphalan, bortezomib, boron, or mannitol
• No peripheral neuropathy ≥ grade 2 within the past 14 days
• No other serious medical or psychiatric illness that could potentially interfere with the completion of study treatment
• PRIOR CONCURRENT THERAPY:
• More than 4 weeks since prior immunotherapy, antibody therapy, or radiotherapy
• More than 4 weeks since prior major surgery
• No prior therapy for myeloma
• * Prior prednisone at a total of 400mg over ≤ 4 days (or an equivalent potency of another steroid) allowed
• No concurrent corticosteroids (≥ 10 mg prednisone/day or equivalent)
• No other concurrent investigational agents
• No other concurrent antimyeloma therapy