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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Given PO
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Clinical response rate will be calculated as proportion (responders/total patients).
Time frame: Up to 2 weeks after study start
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Incidence of adverse events (AEs) occurring during the study will be summarized by system organ class and preferred term. Adverse events will also be summarized by causality and grade. Serious adverse events will be listed separately.
Time frame: Up to 12 weeks after study start
Changes in stool microbiota
16S sequencing will be used to compare changes in stool microbiota.
Time frame: Up to 12 weeks after study start
Changes in gammopathy
Changes in clonal Ig will be used to assess changes in gammopathy.
Time frame: Up to 12 weeks after study start
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