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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted18 and overPharmaceutical / IndustryCDR0000068801
AETERNA-AE-MM-00-02, NCT00022282

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Aeterna Zentaris, Incorporated

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00022282
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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