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

NCT ID: NCT00022282

Last Updated: 2013-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

shark cartilage extract AE-941

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AEterna Zentaris

INDUSTRY

Sponsor Role: lead

Locations

Québec, , Canada

Countries

Canada

Other Identifiers

AETERNA-AE-MM-00-02

Identifier Type: -

Identifier Source: secondary_id

CDR0000068801

Identifier Type: -

Identifier Source: org_study_id