Rifaximin in Patients With Monoclonal Gammopathy

Sponsor
Emory University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03820817
Collaborator
The Leukemia and Lymphoma Society (Other)
48
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42.5
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Study Details

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:
  1. To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy.
SECONDARY OBJECTIVES:
  1. To evaluate safety and tolerability of a 2-week course of rifaximin.

  2. To evaluate changes in stool microbiota by 16S ribosomal ribonucleic acid (rRNA) gene (16S) sequencing.

  3. 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 Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (rifaximin)

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

Drug: Rifaximin
Given PO
Other Names:
  • Xifaxan
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25% [Up to 2 weeks after study start]

      Clinical response rate will be calculated as proportion (responders/total patients).

    Secondary Outcome Measures

    1. Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [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 [Up to 12 weeks after study start]

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

    3. Changes in gammopathy [Up to 12 weeks after study start]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University
    • The Leukemia and Lymphoma Society

    Investigators

    • Principal Investigator: Madhav Dhodapkar, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Madhav Dhodapkar, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT03820817
    Other Study ID Numbers:
    • IRB00106380
    • NCI-2018-02106
    • Winship4480-18
    First Posted:
    Jan 29, 2019
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2021