Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022282
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2001-08-10
Brief Title:
AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
Neovastat AE-941 in Refractory and Early Relapse Multiple Myeloma Patients
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
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 AE-941 may help to slow the growth of multiple myeloma
PURPOSE Phase II trial to study the effectiveness of neovastat in treating patients who have relapsed or refractory multiple myeloma
PURPOSE Phase II trial to study the effectiveness of neovastat in treating patients who have relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Determine the confirmed tumor response rate in patients with early relapse or refractory multiple myeloma treated with AE-941 Neovastat
Determine the safety of this drug in these patients
Evaluate the time to progression in patients treated with this drug
Evaluate the duration of tumor response partial response response and complete response in patients treated with this drug
OUTLINE This is a multicenter open-label study
Patients receive oral AE-941 Neovastat twice daily
Patients are followed every 4 weeks until disease progression
PROJECTED ACCRUAL A total of 125 patients will be accrued for this study
Determine the confirmed tumor response rate in patients with early relapse or refractory multiple myeloma treated with AE-941 Neovastat
Determine the safety of this drug in these patients
Evaluate the time to progression in patients treated with this drug
Evaluate the duration of tumor response partial response response and complete response in patients treated with this drug
OUTLINE This is a multicenter open-label study
Patients receive oral AE-941 Neovastat twice daily
Patients are followed every 4 weeks until disease progression
PROJECTED ACCRUAL A total of 125 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 |
|---|---|---|---|
| AETERNA-AE-MM-00-02 | None | None | None |