Rituximab in Treating Patients With Multiple Myeloma
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them.
PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab in treating patients with multiple myeloma that is newly diagnosed.
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: rituximab Drug: melphalan Drug: prednisone||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Rituxan in the Management of Multiple Myeloma|
|Study Start Date:||November 1998|
|Study Completion Date:||April 2004|
OBJECTIVES: I. Evaluate the role of rituximab in inducing apoptosis of malignant plasma cells in patients with multiple myeloma. II. Evaluate the role of this regimen in improving the response rate to melphalan and prednisone in these patients. III. Determine whether the regimen decreases residual disease in these patients. IV. Evaluate the toxic effects of this regimen in these patients.
OUTLINE: Patients receive rituximab IV every week for 4 weeks. Treatment is repeated every 6 months for six courses. Treatment may be discontinued after four courses if uncontrolled infection occurs. Patients also receive oral melphalan and prednisone for 4 days which begin after the first course of rituximab. Treatment is repeated every 4-6 weeks for at least nine courses.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 12-24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003554
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Mohamad A. Hussein, MD||The Cleveland Clinic|