Rifaximin Versus No Intervention in Patients With IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance
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.
• 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