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OpenTrials
Completed

NCT Number: NCT03820817

Rifaximin in Patients With Monoclonal Gammopathy

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.

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Key information

Conditions

IgA Monoclonal Gammopathy Blood Protein Disorders Cardiovascular Diseases Gammopathy Igg Gammopathy, Monoclonal Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders IgG Monoclonal Gammopathy IgM Monoclonal Gammopathy Immune System Diseases Immunoproliferative Disorders Light Chain Deposition Disease Lymphatic Diseases Lymphoproliferative Disorders Monoclonal Gammopathy Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Smoldering Waldenstrom Macroglobulinemia Vascular Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of monoclonal gammopathy of undetermined significance based on International Myeloma Working Group (IMWG) criteria
  • 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

Treatment and study plan

Rifaximin

Drug

Given PO

Other names: Xifaxan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. Changes in stool microbiota

    Time frame: Up to 12 weeks after study start

    16S sequencing will be used to compare changes in stool microbiota.

  3. Changes in gammopathy

    Time frame: Up to 12 weeks after study start

    Changes in clonal Ig will be used to assess changes in gammopathy.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2019
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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