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 : October 19, 2021
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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 |
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 (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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, 2022 |
Estimated Study Completion Date : | November 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (rifaximin)
Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.
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Drug: Rifaximin
Given PO
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of monoclonal gammopathy of undetermined significance based on International Myeloma Working Group (IMWG) criteria
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Patients will be enrolled into one of 3 cohorts:
- Cohort A: IgA gammopathy
- Cohort B: IgG gammopathy / or light chain gammopathy
- Cohort C: IgM gammopathy / asymptomatic macroglobulinemia
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have received antibiotics within last 3 weeks
- Patients who are receiving any other investigational agents for gammopathy. Patients with clinical myeloma requiring anti-myeloma therapy are also excluded
- History of allergic reactions or intolerance attributed to rifaximin or compounds of similar chemical or biologic composition to antibiotic under study
- The effects of rifaximin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of rifaximin administration

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820817
Contact: Madhav Dhodapkar, MD | 404-778-4191 | madhav.v.dhodapkar@emory.edu |
United States, Georgia | |
Emory University Hospital/Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Shondolyn Richburg 404-778-3612 shondolyn.k.richburg@emory.edu | |
Contact: Eduardo Sanabria 404-778-2164 esanab2@emory.edu |
Principal Investigator: | Madhav Dhodapkar, MD | Emory University |
Responsible Party: | Madhav Dhodapkar, Principal Investigator, Emory University |
ClinicalTrials.gov Identifier: | NCT03820817 |
Other Study ID Numbers: |
IRB00106380 NCI-2018-02106 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) Winship4480-18 ( Other Identifier: Emory University Hospital/Winship Cancer Institute ) |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | October 19, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Waldenstrom Macroglobulinemia Paraproteinemias Monoclonal Gammopathy of Undetermined Significance Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hypergammaglobulinemia Rifaximin Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents |