RecruitingPhase 2NCT07209371

Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance

Rifaximin Versus No Intervention in Patients With IgA Monoclonal Gammopathy of Undetermined Significance


Sponsor

Fred Hutchinson Cancer Center

Enrollment

50 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effect of rifaximin to no intervention for the treatment of IgA monoclonal gammopathy of undetermined significance (MGUS). Rifaximin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill cancer cells or precancerous cells like those found with MGUS. Giving rifaximin may kill more precancerous cells in patients with IgA MGUS.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Age ≥ 18 years
  • Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants
  • Clinical diagnosis of IgA monoclonal gammopathy of undetermined significance (MGUS) based on International Myeloma Working Group (IMWG)-2014 criteria (Rajkumar et al, Lancet Oncology, 2014)
  • Agree to use adequate contraception
  • For women of child-bearing potential: prior to study entry and for the duration of study participation
  • For men: prior to study entry, for the duration of study participation, and one month after completion of rifaximin administration (for men)
  • No antibiotic use in the preceding 2 weeks

Exclusion Criteria3

  • Participants who are receiving other investigational agents
  • Pregnant women
  • Known hypersensitivity to rifaximin

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Interventions

DRUGRifaximin

Given PO

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT07209371