RecruitingPhase 2

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

United States50 participantsStarted 2026-01-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Participants who are receiving other investigational agents * Pregnant women * Known hypersensitivity to rifaximin

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall response rate

Timeframe: From the start of therapy, up to 90 days

Trial details

NCT IDNCT07209371

SponsorFred Hutchinson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-01

Contact for this trial

Madhav Dhodapkar, MBBS

206-606-4888 mdhodapk@fredhutch.org

View on ClinicalTrials.gov More IgA Monoclonal Gammopathy of Undetermined Significance trials