Rifaximin Versus No Intervention in Patients With IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance
Fred Hutchinson Cancer Center
Summary
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 IgG/IgA (non-IgM) monoclonal gammopathy of undetermined significance (MGUS) based on International Myeloma Working Group (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…
Interventions
- DrugRifaximin
Given PO
- ProcedureBiospecimen Collection
Undergo blood sample collection
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington