Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance
NCT ID: NCT07209371
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2026-01-24
2028-05-01
Brief Summary
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Detailed Description
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ARM A: Patients receive rifaximin orally (PO) three times daily (TID) for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
ARM B: Patients undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at 90 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Rifaximin)
Patients receive rifaximin orally (PO) three times daily (TID) for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
Rifaximin
Given PO
Biospecimen Collection
Undergo blood sample collection
Arm B (No intervention)
Patients undergo blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Interventions
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Rifaximin
Given PO
Biospecimen Collection
Undergo blood sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant women
* Known hypersensitivity to rifaximin
18 Years
ALL
No
Sponsors
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Rising Tide Foundation
OTHER
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Madhav Dhodapkar, MBBS
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Madhav Dhodapkar, MBBS
Role: primary
Other Identifiers
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NCI-2025-06773
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHIRB0020984
Identifier Type: OTHER
Identifier Source: secondary_id
RG1125814
Identifier Type: -
Identifier Source: org_study_id