Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Treating Patients With Multiple Myeloma
Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
About this trial
This is an interventional treatment trial for Stage I Multiple Myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma (MM), meeting 1 of the following criteria: Previously untreated disease with poor prognosis, meeting 1 of the following criteria: Active disease with β2 microglobulin ≥ 5.5 mg/dL Inactive disease with peripheral plasma cells OR chromosome 13 or 14 abnormalities by fluorescent in situ hybridization Relapsed or refractory disease Measurable disease by serum and urine M-protein and/or measurable plasmacytoma PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2* NOTE: *ECOG 3 allowed for patients with bone pain due to MM Life expectancy At least 3 months Hematopoietic Platelet count ≥ 75,000/mm^3 unless plasma cells > 50% in bone marrow Any WBC allowed provided plasma cells > 50% in bone marrow Hepatic SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) Bilirubin ≤ 2.5 times ULN Renal Creatinine ≤ 6.0 mg/dL Cardiovascular Absolute QT interval ≤ 460 msec with potassium ≥ 4.0 mEq/L AND magnesium ≥ 1.8 mg/dL No conduction defects No unstable angina No myocardial infarction within the past 6 months No congestive heart failure No New York Heart Association class II-IV heart disease No other significant underlying cardiac dysfunction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy No blood, ova, or sperm donation during study participation No history of grand mal seizures except infantile febrile seizures No pre-existing neurotoxicity or neuropathy ≥ grade 2 No uncontrolled diabetes mellitus No active serious infection that cannot be controlled with antibiotics No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer No other condition that would preclude study compliance or follow up PRIOR CONCURRENT THERAPY: Biologic therapy Prior thalidomide allowed (in patients with relapsed or refractory MM) No prior thalidomide in combination with arsenic trioxide Prior epoetin alfa allowed Chemotherapy See Biologic therapy Prior arsenic trioxide allowed (for patients with relapsed or refractory MM) No concurrent cytotoxic chemotherapy No chemotherapy within 2 weeks after completion of study treatment Endocrine therapy Prior steroid therapy allowed (for patients with relapsed or refractory MM) Radiotherapy No concurrent broad-field radiotherapy Surgery Not specified Other Prior and concurrent bisphosphonates allowed No other concurrent investigational agents
Sites / Locations
- Cleveland Clinic Taussig Cancer Center