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Clinical Trial Summary

This 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.


Clinical Trial Description

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 a 2-week course of rifaximin. II. To evaluate changes in stool microbiota by 16S ribosomal ribonucleic acid (rRNA) gene (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 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 8 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03820817
Study type Interventional
Source Emory University
Contact Madhav Dhodapkar, MD
Phone 404-778-4191
Email madhav.v.dhodapkar@emory.edu
Status Recruiting
Phase Phase 1
Start date May 15, 2019
Completion date November 30, 2025

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