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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
Information provided by:
AEterna Zentaris

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: shark cartilage extract AE-941 Phase 2

Detailed Description:


  • 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.

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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

Information from the National Library of Medicine

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


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 months


  • No clinical symptoms of hyperviscosity


  • Not specified


  • Creatinine no greater than 2 times upper limit of normal
  • Calcium no greater than 11 mg/dL


  • 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


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


  • 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


  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative or curative radiotherapy


  • Not specified


  • 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

Information from the National Library of Medicine

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

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Quebec, Canada
Sponsors and Collaborators
AEterna Zentaris
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ClinicalTrials.gov Identifier: NCT00022282    
Other Study ID Numbers: CDR0000068801
First Posted: October 15, 2003    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2008
Keywords provided by AEterna Zentaris:
refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases