NCT00006466

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: LifeTime Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm
• Precancerous Condition

Interventions

Type	Name	Description
DRUG	beta alethine

Timeline

• Start date: 2000-08-01
• First posted: 2003-10-08
• Last updated: 2013-12-18

Locations

3 sites across 1 country: United States