Spots Global Cancer Trial Database for Rifaximin in Patients With Monoclonal Gammopathy
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Trial Identification
Brief Title: Rifaximin in Patients With Monoclonal Gammopathy
Official Title: Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy
Study ID: NCT03820817
Interventions
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Contact Details
Name: Madhav Dhodapkar, MD
Affiliation: Emory University
Role: PRINCIPAL_INVESTIGATOR
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