Beta Alethine in Treating Patients With Myeloma
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|ClinicalTrials.gov Identifier: NCT00006466|
Recruitment Status : Unknown
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 8, 2003
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition||Drug: beta alethine||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|