Rifaximin in Patients With Monoclonal Gammopathy

NCT03820817 | Active Not Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: IRB00106380NCI-2018-02106Winship4480-18P30CA138292
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Monoclonal Gammopathy; IgG Monoclonal Gammopathy; IgM Monoclonal Gammopathy; Light Chain Deposition Disease; Monoclonal Gammopathy; Smoldering Waldenstrom Macroglobulinemia; Waldenstrom Macroglobulinemia; Gammopathy, Monoclonal; Gammopathy Igg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Up to 12 weeks after study start

• Changes in stool microbiota

  Up to 12 weeks after study start

• Changes in gammopathy

  Up to 12 weeks after study start

Study Arms (1)

Treatment (rifaximin)

EXPERIMENTAL

Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.

Drug: Rifaximin

Interventions

Rifaximin DRUG

Given PO

Also known as: Xifaxan

Treatment (rifaximin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Paraproteinemias; Waldenstrom Macroglobulinemia

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ajay Nooka, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 29, 2019
• Study Start: May 15, 2019
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)