Title
Beta Alethine in Treating Patients With Myeloma
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma
Phase
Phase 1/Phase 2Lead Sponsor
LifeTime PharmaceuticalsStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Multiple Myeloma and Plasma Cell Neoplasm Precancerous ConditionIntervention/Treatment
betathine ...Study Participants
NoneRATIONALE: 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.
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
