Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rifaximin, Biospecimen Collection.
- Who it may be relevant to
- Registry conditions: IgA Monoclonal Gammopathy of Undetermined Significance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Rifaximin Versus No Intervention in Patients With IgA Monoclonal Gammopathy of Undetermined Significance
Overview
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.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
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.
Interventions
- Drug Rifaximin
Given PO - Procedure Biospecimen Collection
Undergo blood sample collection
Primary outcome measures
- Overall response rate [Time frame: From the start of therapy, up to 90 days]
Secondary outcome measures (1)
- Proportion of patients experiencing > grade 2 adverse events [Time frame: From the start of therapy, up to 90 days]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fred Hutch/University of Washington Cancer Consortium — Seattle
Identifiers
NCT: NCT07209371 · RG1125814 · NCI-2025-06773 · FHIRB0020984