AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
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.
Multiple Myeloma and Plasma Cell Neoplasm
Drug: shark cartilage extract AE-941
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients|
|Study Start Date:||April 2001|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
- 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.