- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00022282
AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec, Canada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Other Study ID Numbers
- CDR0000068801
- AETERNA-AE-MM-00-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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