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

Basic Trial Information

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
Information obtained from ClinicalTrials.gov on February 27, 2013

Back to Top