Rifaximin in Patients With Monoclonal Gammopathy

Waldenstrom Macroglobulinemia Clinical Trial

Official title:

Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03820817
• Other study ID #: IRB00106380
• Secondary ID: NCI-2018-02106Wi
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2019
• Est. completion date: November 30, 2025

Study information

• Verified date: March 2024
• Source: Emory University
• Contact: Madhav Dhodapkar, MD
• Phone: 404-778-4191
• Email: madhav.v.dhodapkar[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gammopathy Igg
• Gammopathy, Monoclonal
• IgA Monoclonal Gammopathy
• IgG Monoclonal Gammopathy
• IgM Monoclonal Gammopathy
• Light Chain Deposition Disease
• Monoclonal Gammopathy
• Monoclonal Gammopathy of Undetermined Significance
• Paraproteinemias
• Smoldering Waldenstrom Macroglobulinemia
• Waldenstrom Macroglobulinemia

Intervention

Drug:
• Rifaximin
Given PO

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%	Clinical response rate will be calculated as proportion (responders/total patients).	Up to 2 weeks after study start
Secondary	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.	Up to 12 weeks after study start
Secondary	Changes in stool microbiota	16S sequencing will be used to compare changes in stool microbiota.	Up to 12 weeks after study start
Secondary	Changes in gammopathy	Changes in clonal Ig will be used to assess changes in gammopathy.	Up to 12 weeks after study start