SWOG 0120
A Prospective Observational Biologic Study of Asymptomatic Patients with Monoclonal Gammopathy and Plasma Proliferative Disorders
Sponsor:
PI:
Laura Hutchins, M.D.
Phase:
II
Purpose:
This study does not involve treatment. It is an "observational" study only. Your disease (monoclonal gammopathy or myeloma without symptoms) is considered to be at a stage that does not require immediate treatment and will be monitored for the purpose of learning more about the disease. The purpose of this study is to take samples of your bone marrow and blood to learn more about the disease. Specifically, the researchers want to understand more out genetic changes in the tumor and about the response of your immune system to your tumor. With your additional approval, some cells will be frozen, so that they may be examined later if new tests become available.
Eligibility:
An estimated 200 subjects, ages 18 and older, will be entered onto this study at this institution. National accrual is anticipated to be about 200 subjects.
Treatment:
Samples of your blood and bone marrow will be taken for the purpose of scientific studies. These blood and bone marrow samples will be obtained approximately one month after initial study registration at the Myeloma Institute for Research and Therapy in Little Rock, Arkansas, or at Rockefeller University in New York, New York, and optionally at 12 months after registration at your local institution. Bone marrow and blood samples drawn within one month before registration will also be acceptable, provided they were obtained at either the Myeloma Institute for Research and Therapy or at Rockefeller University.
The length of time you will be on this study is 5 years or until worsening of your disease, whichever is first.
