Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With 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.
Interventional
Primary Purpose: Treatment
Suzin Mayerson, PhD
Study Chair
LifeTime Pharmaceuticals
United States: Federal Government
CDR0000068280
NCT00006466
August 2000
Name | Location |
---|---|
St. Vincents Comprehensive Cancer Center | New York, New York 10011 |
Emory Clinic | Atlanta, Georgia 30365 |
Victory Over Cancer | Rockville, Maryland 20852 |