About this trial
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.
Eligibility criteria
Qualifiers
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 clinically indicated per treating provider
Agree to use adequate contraception
Disqualifiers
Participants who are receiving other investigational agents
Pregnant women
Known hypersensitivity to rifaximin
Another concurrent malignancy requiring active therapy
Trial design
Treatments tested in this trial
- Rifaximin
- Biospecimen Collection
Treatment groups
Sponsors and collaborators
Fred Hutchinson Cancer Center
Lead sponsor
Rising Tide Foundation
Collaborator