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.
Additional locations may be listed on ClinicalTrials.gov for NCT07209371.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Approved
Contact: Madhav V. Dhodapkar
Phone: 206-667-4259
PRIMARY OBJECTIVE:
I. To evaluate the effect of a course of rifaximin on clonal Ig in patients with IgA monoclonal gammopathy.
SECONDARY OBJECTIVE:
I. To evaluate safety and tolerability of a 2-week course of rifaximin.
EXPLORATORY OBJECTIVES:
I. Changes in gut microbiome (beta diversity) following antibiotic therapy.
II. Changes in inflammatory cytokines (IL1b, IL12p70) following antibiotic therapy.
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.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorMadhav V. Dhodapkar
