NCT07209371 Rifaximin Versus No Intervention for the Treatment of IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance
| NCT ID | NCT07209371 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fred Hutchinson Cancer Center |
| Condition | IgA Monoclonal Gammopathy of Undetermined Significance |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-01-22 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial compares the effect of rifaximin to no intervention for the treatment of IgG/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 IgG/IgA MGUS.
Eligibility Criteria
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 IgG/IgA (non-IgM) monoclonal gammopathy of undetermined significance (MGUS) based on International Myeloma Working Group (IMWG)-2014 criteria (Rajkumar et al, Lancet Oncology, 2014). It is recognized that not all patients with clinical diagnosis of MGUS undergo bone marrow biopsy. Bone marrow biopsy confirmation will not be required if not clinically indicated per treating provider * 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 * Another concurrent malignancy requiring active therapy
Contact & Investigator
Madhav Dhodapkar, MBBS
PRINCIPAL INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Frequently Asked Questions
Who can join the NCT07209371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IgA Monoclonal Gammopathy of Undetermined Significance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07209371 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07209371 currently recruiting?
Yes, NCT07209371 is actively recruiting participants. Contact the research team at mdhodapk@fredhutch.org for enrollment information.
Where is the NCT07209371 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT07209371 clinical trial?
NCT07209371 is sponsored by Fred Hutchinson Cancer Center. The principal investigator is Madhav Dhodapkar, MBBS at Fred Hutch/University of Washington Cancer Consortium. The trial plans to enroll 50 participants.