Rifaximin in Patients With Monoclonal Gammopathy
Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy
This 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.
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 a 2-week course of rifaximin. II. To evaluate changes in stool microbiota by 16S ribosomal ribonucleic acid (rRNA) gene (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 8 weeks.
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
IgA Monoclonal Gammopathy
Study Arms / Comparison Groups
Description: Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
May 15, 2019
November 30, 2024
Primary Completion Date
November 30, 2024
Inclusion Criteria: - Clinical diagnosis of monoclonal gammopathy of undetermined significance based on International Myeloma Working Group (IMWG) criteria - 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 - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have received antibiotics within last 3 weeks - Patients who are receiving any other investigational agents for gammopathy. Patients with clinical myeloma requiring anti-myeloma therapy are also excluded - History of allergic reactions or intolerance attributed to rifaximin or compounds of similar chemical or biologic composition to antibiotic under study - The effects of rifaximin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of rifaximin administration
18 Years - N/A
Accepts Healthy Volunteers
Madhav Dhodapkar, MD, 404-778-4191, m[email protected]
Madhav Dhodapkar, MD, Principal Investigator, Emory University