Rifaximin Versus No Intervention for the Treatment of IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

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

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

Rising Tide Foundation

Collaborator