Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006466
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2000-11-06
Brief Title:
Beta Alethine in Treating Patients With Myeloma
Sponsor:
LifeTime Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma
Status:
UNKNOWN
Status Verified Date:
2002-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III trial to study the effectiveness of beta alethine in treating patients who have myeloma
PURPOSE Phase III 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LIFETIME-IRB-0300203 | None | None | None |
| LIFETIME-LTP-99-01 | None | None | None |