Beta Alethine in Treating Patients With Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell NeoplasmPrecancerous Condition
- Registration Number
- NCT00006466
- Lead Sponsor
- LifeTime Pharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Emory Clinic
🇺🇸Atlanta, Georgia, United States
Victory Over Cancer
🇺🇸Rockville, Maryland, United States
St. Vincents Comprehensive Cancer Center
🇺🇸New York, New York, United States
Emory Clinic🇺🇸Atlanta, Georgia, United States