Brief Title
Rifaximin in Patients With Monoclonal Gammopathy
Official Title
Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy
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 or cells in patients with monoclonal gammopathy.
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 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Secondary Outcome
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Condition
IgA Monoclonal Gammopathy
Intervention
Rifaximin
Study Arms / Comparison Groups
Treatment (rifaximin)
Description: Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
48
Start Date
May 15, 2019
Completion Date
November 30, 2024
Primary Completion Date
November 30, 2024
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Madhav Dhodapkar, MD, 404-778-4191, m[email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03820817
Organization ID
IRB00106380
Secondary IDs
NCI-2018-02106
Responsible Party
Principal Investigator
Study Sponsor
Emory University
Study Sponsor
Madhav Dhodapkar, MD, Principal Investigator, Emory University
Verification Date
February 2023