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Rifaximin in Treating Patients with Monoclonal Gammopathy

Cancer Type
Multiple Myeloma
Plasma cell neoplasm
Trial Phase
Phase I
18 Years and older, Male and Female
Study Type
Protocol IDs
Winship4480-18 (primary)
Study Sponsor
Emory University Hospital/Winship Cancer Institute


This phase I trial studies how well rifaximin works in treating patients with monoclonal gammopathy. Antibiotics, such as rifaximin, may help to kill bacteria in the intestines and reduce the abnormal protein or cells in patients with monoclonal gammopathy.


I. To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy.

I. To evaluate safety and tolerability of 2-week course of rifaximin.
II. To evaluate changes in stool microbiota by 16S sequencing.
III. To evaluate changes in gammopathy as assessed by changes in clonal Ig and/or plasma cells.

Patients receive rifaximin orally (PO) thrice daily (TID) on days 1-14 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 8 weeks.


  1. Clinical diagnosis of asymptomatic gammopathy (monoclonal gammopathy of undetermined significance or asymptomatic myeloma or asymptomatic macroglobulinemia) based on International Myeloma Working Group (IMWG) criteria
  2. Patients will be enrolled into one of 3 cohorts: * Cohort A: IgA gammopathy * Cohort B: IgG gammopathy / or light chain gammopathy * Cohort C: IgM gammopathy / asymptomatic macroglobulinemia
  3. Age >= 18 years
  4. Ability to understand and the willingness to sign a written informed consent document

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE


Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.