Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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