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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
shark cartilage extract AE-941
Sponsored by
AEterna Zentaris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
February 27, 2013
Sponsor
AEterna Zentaris
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1. Study Identification

Unique Protocol Identification Number
NCT00022282
Brief Title
AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Official Title
Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
AEterna Zentaris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
shark cartilage extract AE-941

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Quebec
Country
Canada

12. IPD Sharing Statement

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

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