Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	Pharmaceutical / Industry	AETERNA-AE-MM-00-02 NCT00022282

Objectives

1. Determine the confirmed tumor response rate in patients with early relapse or refractory multiple myeloma treated with AE-941 (Neovastat).
2. Determine the safety of this drug in these patients.
3. Evaluate the time to progression in patients treated with this drug.
4. Evaluate the duration of tumor response (partial response, response, and complete response) in patients treated with this drug.

Entry 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

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

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

Expected Enrollment

A total of 125 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Aeterna Zentaris, Incorporated

Pierre Champagne, MD, Protocol chair(Contact information may not be current)		Ph: 418-652-8525

Registry Information
Official Title		Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients
Trial Start Date		2001-04-04
Trial Completion Date		2007-03-05
Registered in ClinicalTrials.gov		NCT00022282
Date Submitted to PDQ		2001-06-13
Information Last Verified		2008-02-06

Back to Top