Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00022282
Recruitment Status : Completed
First Posted : October 15, 2003
Last Update Posted : February 28, 2013
Sponsor:
Information provided by:
AEterna Zentaris

Tracking Information
First Submitted Date  ICMJE August 10, 2001
First Posted Date  ICMJE October 15, 2003
Last Update Posted Date February 28, 2013
Study Start Date  ICMJE April 2001
Actual 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
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma and Plasma Cell Neoplasm
Intervention  ICMJE Drug: shark cartilage extract AE-941
Study Arms  ICMJE 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
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00022282
Other Study ID Numbers  ICMJE CDR0000068801
AETERNA-AE-MM-00-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AEterna Zentaris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AEterna Zentaris
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP