Clinical trial · Interventional
Rifaximin in Patients With Monoclonal Gammopathy
Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy
NCT03820817CI-TRIAL-00112551completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gammopathy Igg | — | UNRESOLVED | — |
| Gammopathy, Monoclonal | — | UNRESOLVED | — |
| IgA Monoclonal Gammopathy | — | UNRESOLVED | — |
| IgG Monoclonal Gammopathy | — | UNRESOLVED | — |
| IgM Monoclonal Gammopathy | — | UNRESOLVED | — |
| Light Chain Deposition Disease | Light Chain Deposition Disease | ONTOLOGY_EXACT | 0.98 |
| Monoclonal Gammopathy | — | UNRESOLVED | — |
| Smoldering Waldenstrom Macroglobulinemia | Smoldering Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
| Waldenstrom Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rifaximin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (rifaximin)
- description
- Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Rifaximin
Primary outcomes (1)
- measure
- Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
- timeFrame
- Up to 2 weeks after study start
- description
- Clinical response rate will be calculated as proportion (responders/total patients).
Secondary outcomes (3)
- measure
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.