Status:
ACTIVE_NOT_RECRUITING
Rifaximin in Patients With Monoclonal Gammopathy
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
IgA Monoclonal Gammopathy
IgG Monoclonal Gammopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03820817
Start Date
May 15 2019
End Date
November 30 2025
Last Update
April 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322