Trials / Completed
CompletedNCT00022282
AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- AEterna Zentaris · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | shark cartilage extract AE-941 |
Timeline
- Start date
- 2001-04-01
- Primary completion
- 2007-03-01
- First posted
- 2003-10-15
- Last updated
- 2013-02-28
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00022282. Inclusion in this directory is not an endorsement.