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
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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 |
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.
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients |
Study Start Date : | April 2001 |
Actual Primary Completion Date : | March 2007 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

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
Canada | |
Quebec, Canada |
ClinicalTrials.gov Identifier: | NCT00022282 |
Other Study ID Numbers: |
CDR0000068801 AETERNA-AE-MM-00-02 |
First Posted: | October 15, 2003 Key Record Dates |
Last Update Posted: | February 28, 2013 |
Last Verified: | February 2008 |
refractory multiple myeloma |
Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |