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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
* For women of child-bearing potential: prior to study entry and for the duration of study participation
* For men: prior to study entry, for the duration of study participation, and one month after completion of rifaximin administration (for men)
No antibiotic use in the preceding 2 weeks
You may not be if
Participants who are receiving other investigational agents
Pregnant women
Known hypersensitivity to rifaximin
Another concurrent malignancy requiring active therapy
Clareo Health | Rifaximin Versus No Intervention for the Treatment of IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance
