Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Stage II Multiple Myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma meeting at least 1 of the following criteria: Relapsed disease after a response to standard first-line chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone [VAD] OR melphalan and prednisone) or first-line high-dose chemotherapy Refractory disease (failed to achieve at least stable disease) to most recent chemotherapy with or without systemic corticosteroids 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 No non-secretory myeloma No plasma cell leukemia PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 3 months Hematopoietic Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if bone marrow is extensively infiltrated) Hemoglobin ≥ 8.0 g/dL Absolute neutrophil count ≥ 1,000/mm^3 Pancytopenia secondary to multiple myeloma or hypersplenism allowed Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ 2 times ULN (unless clearly related to disease) No known active hepatitis B or C infection Renal Calcium < 14 mg/dL Cardiovascular No evidence of acute ischemia or new conduction system abnormality by electrocardiogram No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart failure No poorly controlled hypertension No prolonged corrected QT interval (> 460 ms) with potassium > 4 mmol/L and magnesium ≥ 1.8 mmol/L Other No active infection No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) No diabetes mellitus No other serious medical or psychiatric illness that would preclude study participation No known allergic reaction attributable to compounds of similar chemical or biological composition to study drugs No history of grand mal seizures HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior immunotherapy or antibody therapy Chemotherapy See Disease Characteristics More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy See Disease Characteristics No other concurrent corticosteroids Radiotherapy More than 4 weeks since prior radiotherapy Surgery More than 4 weeks since prior major surgery Other No other concurrent investigational agents
Sites / Locations
- Palo Verde Hematology Oncology
- Comprehensive Blood and Cancer Center
- Southbay Oncology / Hematology Medical Group
- Hematology-Oncology Medical Group of Fresno, Incorporated
- Hematology Oncology Medical Group of Orange County, Incorporated
- Cancer Care Associates Medical Group - Redondo Beach
- Redwood Regional Oncology Center - Sotoyome
- Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
- San Diego Cancer Center - Vista
- Oncotherapeutics
- Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
- Atlanta Cancer Care - Roswell
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Center for Cancer and Blood Disorders at Suburban Hospital
- William Beaumont Hospital - Royal Oak Campus
- Hackensack University Medical Center Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
- Utah Cancer Specialists - Administrative Office