This trial is active, not recruiting.

Conditions multiple myeloma and plasma cell neoplasm, precancerous condition
Treatment beta alethine
Phase phase 1/phase 2
Sponsor LifeTime Pharmaceuticals
Start date August 2000
Trial identifier NCT00006466, CDR0000068280, LIFETIME-IRB-0300203, LIFETIME-LTP-99-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).