Beta Alethine in Treating Patients With Myeloma
Recruitment status was: Active, not recruiting
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.
|Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition||Drug: beta alethine||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma|
|Study Start Date:||August 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006466
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Victory Over Cancer|
|Rockville, Maryland, United States, 20852|
|United States, New York|
|St. Vincents Comprehensive Cancer Center|
|New York, New York, United States, 10011|
|Study Chair:||Suzin Mayerson, PhD||LifeTime Pharmaceuticals|