AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00022282|
Recruitment Status : Completed
First Posted : October 15, 2003
Last Update Posted : February 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: shark cartilage extract AE-941||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||March 2007|
U.S. FDA Resources
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): NCT00022282