search
Back to results

Rifaximin in Patients With Monoclonal Gammopathy

Primary Purpose

IgA Monoclonal Gammopathy, IgG Monoclonal Gammopathy, IgM Monoclonal Gammopathy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Monoclonal Gammopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University Hospital/Winship Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (rifaximin)

Arm Description

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

Outcomes

Primary Outcome Measures

Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Clinical response rate will be calculated as proportion (responders/total patients).

Secondary Outcome Measures

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.
Changes in stool microbiota
16S sequencing will be used to compare changes in stool microbiota.
Changes in gammopathy
Changes in clonal Ig will be used to assess changes in gammopathy.

Full Information

First Posted
January 28, 2019
Last Updated
February 13, 2023
Sponsor
Emory University
search

1. Study Identification

Unique Protocol Identification Number
NCT03820817
Brief Title
Rifaximin in Patients With Monoclonal Gammopathy
Official Title
Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Monoclonal Gammopathy, IgG Monoclonal Gammopathy, IgM Monoclonal Gammopathy, Light Chain Deposition Disease, Monoclonal Gammopathy, Smoldering Waldenstrom Macroglobulinemia, Waldenstrom Macroglobulinemia, Gammopathy, Monoclonal, Gammopathy Igg

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (rifaximin)
Arm Type
Experimental
Arm Description
Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Xifaxan
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Description
Clinical response rate will be calculated as proportion (responders/total patients).
Time Frame
Up to 2 weeks after study start
Secondary Outcome Measure Information:
Title
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Description
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.
Time Frame
Up to 12 weeks after study start
Title
Changes in stool microbiota
Description
16S sequencing will be used to compare changes in stool microbiota.
Time Frame
Up to 12 weeks after study start
Title
Changes in gammopathy
Description
Changes in clonal Ig will be used to assess changes in gammopathy.
Time Frame
Up to 12 weeks after study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madhav Dhodapkar, MD
Phone
404-778-4191
Email
madhav.v.dhodapkar@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhav Dhodapkar, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan Burton
Phone
404-778-3612
Email
bryan.james.burton@emory.edy
First Name & Middle Initial & Last Name & Degree
Eduardo Sanabria
Phone
404-778-2164
Email
esanab2@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Rifaximin in Patients With Monoclonal Gammopathy

We'll reach out to this number within 24 hrs