Rifaximin in Treating Patients with Monoclonal Gammopathy

Active:	Yes
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT03820817
Trial Phases:	Phase I	Protocol IDs:	Winship4480-18 (primary) NCI-2018-02106 IRB00106380
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03820817

Summary

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.

Objectives

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

SECONDARY OBJECTIVES:
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.

OUTLINE:
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 up to 12 weeks from initiation of therapy.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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