Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance

Purpose

This phase II trial compares the effect of rifaximin to no intervention for the treatment of 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 IgA MGUS.

Condition

  • IgA Monoclonal Gammopathy of Undetermined Significance

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 IgA monoclonal gammopathy of undetermined significance (MGUS) based on International Myeloma Working Group (IMWG)-2014 criteria (Rajkumar et al, Lancet Oncology, 2014) - 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

Exclusion Criteria

  • Participants who are receiving other investigational agents - Pregnant women - Known hypersensitivity to rifaximin

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (Rifaximin) 		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.
  • Drug: Rifaximin
    Given PO
    Other names:
    • Xifaxan
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
Other
Arm B (No intervention) 		Patients undergo blood sample collection throughout the study.
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection

Recruiting Locations

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
Contact:
Madhav Dhodapkar, MBBS
206-606-4888
mdhodapk@fredhutch.org

More Details

Status
Recruiting
Sponsor
Fred Hutchinson Cancer Center

Study Contact

Madhav Dhodapkar, MBBS
206-606-4888
mdhodapk@fredhutch.org

Detailed 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.