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

Inclusion Criteria

• •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