ae-941 in treating patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

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.

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

Keywords: refractory multiple myeloma