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
  Purpose

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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: shark cartilage extract AE-941
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Study Start Date: April 2001
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022282

Locations
Canada
Quebec, Canada
Sponsors and Collaborators
AEterna Zentaris
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00022282     History of Changes
Other Study ID Numbers: CDR0000068801, AETERNA-AE-MM-00-02
Study First Received: August 10, 2001
Last Updated: February 27, 2013
Health Authority: United States: Federal Government

Keywords provided by AEterna Zentaris:
refractory multiple myeloma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 22, 2014