Beta Alethine in Treating Patients With Myeloma
Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring monoclonal gammopathy of undetermined significance, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven myeloma Multiple myeloma Indolent myeloma with slowly progressive bone pathology Smoldering myeloma with no bone pathology but a progressive increase in M-protein Solitary myeloma OR Diagnosis of evolving monoclonal gammopathy of undetermined significance with increasing M-protein or decreasing hemoglobin level Measurable M-protein or Bence Jones protein Indolent disease not requiring therapy allowed No clinical signs or evidence of active brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: At least 4 months Hematopoietic: See Disease Characteristics Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No acute changes on electrocardiogram No uncontrolled angina, heart failure, or arrhythmia Other: Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L) HIV negative No AIDS No active bacterial infection (e.g., abscess) or with fistula No history of alcoholism, drug addiction, or psychotic disorders that would preclude study No other nonmalignant disease that would preclude study Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy or cytokines Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin) Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow Surgery: Recovered from any prior surgery No prior solid organ transplantation Other: No other concurrent investigational agent No concurrent immunosuppressive agents No concurrent anti-inflammatory agents, including aspirin or over-the-counter or prescription nonsteroidal anti-inflammatory drugs
Sites / Locations
- Emory Clinic
- Victory Over Cancer
- St. Vincents Comprehensive Cancer Center