IgA Monoclonal GammopathyPhase 1NCT03820817
Rifaximin in Patients With Monoclonal Gammopathy
A Phase 1 study testing Rifaximin in people with IgA Monoclonal Gammopathy and IgG Monoclonal Gammopathy, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Monoclonal Gammopathy, IgG Monoclonal Gammopathy, IgM Monoclonal Gammopathy
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 30 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- IgA Monoclonal Gammopathy, IgG Monoclonal Gammopathy, IgM Monoclonal Gammopathy, Light Chain Deposition Disease, Monoclonal Gammopathy, Smoldering Waldenstrom Macroglobulinemia
- Being tested
- Rifaximin
- Medical subject headings
- Paraproteinemias, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Xifaxan
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (rifaximin) | Experimental | Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity. Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Clinical response rate will be calculated as proportion (responders/total patients).
Measured: Up to 2 weeks after study start
Secondary outcomes (3)
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Incidence of adverse events (AEs) occurring during the study will be summarized by system organ class and preferred term. Adverse events will also be summarized by causality and grade. Serious adverse events will be listed separately.
Measured: Up to 12 weeks after study start
Changes in stool microbiota
16S sequencing will be used to compare changes in stool microbiota.
Measured: Up to 12 weeks after study start
Changes in gammopathy
Changes in clonal Ig will be used to assess changes in gammopathy.
Measured: Up to 12 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start15 May 2019
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Monoclonal GammopathyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ajay Nooka, Emory University
- Investigators
- Ajay Nooka, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820817
- Sponsor's protocol ID
- IRB00106380
- Other IDs
- NCI-2018-02106, Winship4480-18, P30CA138292
- Status last verified
- May 2026
- First submitted
- 28 Jan 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy
- ClinicalTrials.gov ID
- NCT03820817
- Acronym / sponsor ID
- IRB00106380
- Conditions
- IgA Monoclonal Gammopathy, IgG Monoclonal Gammopathy, IgM Monoclonal Gammopathy, Light Chain Deposition Disease, Monoclonal Gammopathy, Smoldering Waldenstrom Macroglobulinemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (rifaximin) | Experimental | Drug: RifaximinPatients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifaximinAlso: XifaxanGiven PO | Drug | Treatment (rifaximin) |
Primary outcome
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Time frame: Up to 2 weeks after study start
Clinical response rate will be calculated as proportion (responders/total patients).
3 secondary outcomes
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 12 weeks after study start
Changes in stool microbiota
Time frame: Up to 12 weeks after study start
Changes in gammopathy
Time frame: Up to 12 weeks after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Nooka, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rifaximin in people with IgA Monoclonal Gammopathy and IgG Monoclonal Gammopathy, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25% (time frame: Up to 2 weeks after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.