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

AEterna Zentaris

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Treatments: Drug: shark cartilage extract AE-941

Study type: Interventional

Funder types: Industry

Identifiers

NCT00022282

CDR0000068801

AETERNA-AE-MM-00-02

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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