Rifaximin in Patients With Monoclonal Gammopathy

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    48
  • sponsor
    Emory University
Updated on 26 January 2021
antibiotics
multiple myeloma

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.

Details
Condition Monoclonal gammopathy, Waldenstrom's Macroglobulinemia, Monoclonal Gammopathy of Undetermined Significance, Lymphoproliferative Disorder, Light Chain Deposition Disease, Lymphoproliferative disorders, Waldenstrom Macroglobulinemia, IgA Monoclonal Gammopathy, IgG Monoclonal Gammopathy, IgM Monoclonal Gammopathy, Smoldering Waldenstrom Macroglobulinemia, Gammopathy Igg, monoclonal gammopathies
Treatment Rifaximin
Clinical Study IdentifierNCT03820817
SponsorEmory University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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