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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Given PO
Undergo blood sample collection
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGOverall response rate
Defined as the proportion of patients with \> 25% decline in clonal Ig at any point within 90 days after the initiation of drug or no intervention. Logistic regression will be conducted to evaluate the association between endpoint of interest and treatment (Arm A versus \[vs\] B).
Time frame: From the start of therapy, up to 90 days
Proportion of patients experiencing > grade 2 adverse events
Logistic regression will be conducted to evaluate the association between endpoint of interest and treatment (Arm A vs B).
Time frame: From the start of therapy, up to 90 days
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