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Rifaximin Versus No Intervention for the Treatment of IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance

StatusRecruiting
PhasePhase 2
Started2026-01-22
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
Study Identification, Study Status, Study Description, Conditions, Eligibility v6
Eligibility criteria+272 characters
[...] ehalf of potential study participants Clinical diagnosis of IgG/IgA (non-IgM) monoclonal gammopathy of undetermined significance (MGUS) b [...] (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-beari [...] al agents Pregnant women Known hypersensitivity to rifaximin Another concurrent malignancy requiring active therapy
Study title+14 characters
Rifaximin Versus No Intervention for the Treatment of IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance
2026-04-16
Study Status v5
Re-verified, no change to tracked fields
2026-01-26
Study Status v4
Start dateestimated 2026-01-24→confirmed 2026-01-22
2025-12-24
Study Identification, Study Status v3
Start date2025-12-19→2026-01-24
2025-11-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2026-03-01→2025-12-19
Study sitesdetails revised at 1 of 1 site
2025-10-15
Study Status v1
Re-verified, no change to tracked fields
2025-10-01
Original filing
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.
Trial Details
NCT Number NCT07209371
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Rising Tide Foundation
Conditions IgA Monoclonal Gammopathy of Undetermined Significance, Non-IgM Monoclonal Gammopathy of Undetermined Significance
Enrollment 50 participants
Start Date 2026-01-22
Primary Completion 2028-05-01 (estimated)
Study Completion 2028-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-17