Bortezomib, Ascorbic Acid, and Melphalan in Treating Patients With Newly Diagnosed Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility 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
Sites / Locations
- Hematology-Oncology Medical Group of Fresno, Incorporated
- Hematology Oncology Medical Group of Orange County, Incorporated
- Oncotherapeutics
- Florida Cancer Specialists - Bonita Springs
- Florida Oncology Associates
- Atlanta Cancer Care - Roswell
- University of Chicago Cancer Research Center
- SUNY Downstate Medical Center