Status:
RECRUITING
Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
Rising Tide Foundation
Conditions:
IgA Monoclonal Gammopathy of Undetermined Significance
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 on...
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. Pati...
Eligibility Criteria
Inclusion
- 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
- Participants who are receiving other investigational agents
- Pregnant women
- Known hypersensitivity to rifaximin
Key Trial Info
Start Date :
January 24 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07209371
Start Date
January 24 2026
End Date
May 1 2028
Last Update
December 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109