Trial Information

Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma Whose Disease Has Been Controlled With Chemotherapy: Rituximab Anti-CD20 Monoclonal Antibody or Interferon Alpha 2-b as Maintenance Therapy

OBJECTIVES: I. Determine the toxicity of rituximab or interferon alfa-2b maintenance therapy
in patients with chronic lymphocytic leukemia or multiple myeloma in remission after
chemotherapy. II. Determine the progression free survival, failure free survival, and
overall survival of these patients from time of chemotherapy discontinuation to completion
of maintenance therapy. III. Compare the survival rates of these patients to similar
patients treated in published studies. IV. Determine the quality of life of these patients
on these regimens.

OUTLINE: Patients enter one of two treatment arms: Arm I: Patients receive rituximab IV on
days 1, 8, 15, and 22 for course 1, and then once a month for 11 months or until disease
progression. Arm II: Patients receive subcutaneous interferon alfa-2b every other day three
times per week for 12 months. Quality of life is assessed monthly during therapy. Patients
are followed every 3 months for 1 year, and then annually for up to 5 years.

PROJECTED ACCRUAL: A total of 60-80 patients (30-40 per disease type) will be accrued for
this study.