This phase I trial studies how well rifaximin works in treating patients with monoclonal gammopathy. Antibiotics, such as rifaximin, may help to kill bacteria in the intestines and reduce the abnormal protein or cells in patients with monoclonal gammopathy.
Additional locations may be listed on ClinicalTrials.gov for NCT03820817.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Ajay Kumar Nooka
Phone: 404-778-1900
PRIMARY OBJECTIVE:
I. To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy.
SECONDARY OBJECTIVES:
I. To evaluate safety and tolerability of 2-week course of rifaximin.
II. To evaluate changes in stool microbiota by 16S sequencing.
III. To evaluate changes in gammopathy as assessed by changes in clonal Ig and/or plasma cells.
OUTLINE:
Patients receive rifaximin orally (PO) thrice daily (TID) on days 1-14 or 1-28 in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study.
After completion of study treatment, patients are followed for up to 12 weeks from initiation of therapy.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorAjay Kumar Nooka
