Rifaximin in Patients With Monoclonal Gammopathy
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|ClinicalTrials.gov Identifier: NCT03820817|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|IgA Monoclonal Gammopathy IgG Monoclonal Gammopathy IgM Monoclonal Gammopathy Light Chain Deposition Disease Monoclonal Gammopathy Smoldering Waldenstrom Macroglobulinemia Waldenstrom Macroglobulinemia Gammopathy, Monoclonal Gammopathy Igg||Drug: Rifaximin||Phase 1|
I. To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy.
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.
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 (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: Treatment (rifaximin)
Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.
Other Name: Xifaxan
- Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25% [ Time Frame: Up to 2 weeks after study start ]Clinical response rate will be calculated as proportion (responders/total patients).
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 12 weeks after study start ]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.
- Changes in stool microbiota [ Time Frame: Up to 12 weeks after study start ]16S sequencing will be used to compare changes in stool microbiota.
- Changes in gammopathy [ Time Frame: Up to 12 weeks after study start ]Changes in clonal Ig will be used to assess changes in gammopathy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820817
|Contact: Madhav Dhodapkar, MDfirstname.lastname@example.org|
|Principal Investigator:||Madhav Dhodapkar, MD||Emory University|