Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
Conditions
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
Brief 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.
Detailed description
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.
Interventions
DRUGbeta alethine
Sponsors
LifeTime Pharmaceuticals
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed