AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
This study has been completed.
Sponsor:
AEterna Zentaris
Information provided by:
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT00022282
First received: August 10, 2001
Last updated: February 27, 2013
Last verified: February 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: shark cartilage extract AE-941 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients |
Resource links provided by NLM:
Further study details as provided by AEterna Zentaris:
| Study Start Date: | April 2001 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma (MM) according to the Durie and Salmon criteria
- Refractory to or in early relapse after standard chemotherapy with or without stem cell transplantation
Measurable disease
- Quantifiable IgM, IgG, or IgA paraprotein in serum AND/OR
- Bence-Jones protein in urine
- No plasma cell leukemia (more than 20% plasma cells in peripheral blood and an absolute plasma cell count of at least 2,000/mm3)
- No nonsecretory MM
- No spinal cord compression
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 6 months
Hematopoietic:
- No clinical symptoms of hyperviscosity
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 2 times upper limit of normal
- Calcium no greater than 11 mg/dL
Other:
- No other prior malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No severe allergy to fish or seafood
- No medical condition that would interfere with intake and/or absorption of study medication (e.g., gastrectomy or major intestinal resection)
- No significant medical or psychiatric condition that would preclude study participation
- Not pregnant
- Negative pregnancy test
- Fertile patients must use adequate contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior history of treatment with thalidomide for more than 14 days duration
- At least 4 weeks since prior biological therapy for MM
- Concurrent epoetin alfa allowed
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy for MM
Endocrine therapy:
- At least 4 weeks since prior steroid therapy for MM
- No prednisone maintenance therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent palliative or curative radiotherapy
Surgery:
- Not specified
Other:
- At least 28 days since other prior shark cartilage products
- At least 28 days since other prior experimental therapeutic agents
- Concurrent monthly bisphosphonate (pamidronates) infusions allowed
- No other concurrent anticancer treatment
- No other concurrent shark cartilage products
- No other concurrent therapies for MM
Contacts and Locations
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00022282 History of Changes |
| Other Study ID Numbers: | CDR0000068801, AETERNA-AE-MM-00-02 |
| Study First Received: | August 10, 2001 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by AEterna Zentaris:
|
refractory multiple myeloma |
Additional relevant MeSH terms:
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013