beta alethine in treating patients with myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition

Summary: rationale: biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing. purpose: phase i/ii trial to study the effectiveness of beta alethine in treating patients who have myeloma.

objectives: * determine the antitumor effects of low-dose beta alethine in patients with myeloma or progressive monoclonal gammopathy of undetermined significance. * determine the effects of this regimen on anemia, performance status, pain, and delayed-type hypersensitivity (immune response) in these patients. * determine the safety of this regimen in these patients. outline: this is a multicenter study. patients receive beta alethine subcutaneously every 2 weeks for 6 doses. at day 85, patients may receive an additional 12-week course of therapy in the absence of disease progression or unacceptable toxicity. patients with an apparent complete response receive additional courses. patients are followed for 2 weeks. projected accrual: a total of 13-37 patients will be accrued for this study.

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

Keywords: 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