Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
refractory multiple myeloma
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.
Interventions
Sponsors
AEterna Zentaris
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
Canada
Outcome results
None listed