NCT07209371

Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance

Rifaximin Versus No Intervention in Patients With IgA Monoclonal Gammopathy of Undetermined Significance

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• IgA Monoclonal Gammopathy of Undetermined Significance

Interventions

Type	Name	Description
DRUG	Rifaximin	Given PO
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2026-01-22
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-10-07
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study