AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study has been completed.

Sponsor:

Information provided by:

AEterna Zentaris

ClinicalTrials.gov Identifier:

NCT00022282

First received: August 10, 2001

Last updated: February 27, 2013

Last verified: February 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	August 10, 2001
Last Updated Date	February 27, 2013
Start Date ^ICMJE	April 2001
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00022282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Official Title ^ICMJE	Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients
Brief 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Multiple Myeloma and Plasma Cell Neoplasm
Intervention ^ICMJE	Drug: shark cartilage extract AE-941
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00022282
Other Study ID Numbers ^ICMJE	CDR0000068801, AETERNA-AE-MM-00-02
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	AEterna Zentaris
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AEterna Zentaris
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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