Blood and Lymph Conditions

Immune System Diseases

All Conditions

Neoplasms

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Monoclonal Gammopathy of Undetermined Significance

Waldenstrom Macroglobulinemia

Paraproteinemias

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hypergammaglobulinemia

Light Chain Deposition Disease

Anti-Infective Agents

Gastrointestinal Agents

All Drugs and Chemicals

Rifaximin

Anti-Bacterial Agents

Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.

Madhav Dhodapkar, MD

Bryan Burton

Eduardo Sanabria

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.

Rifaximin in Patients With Monoclonal Gammopathy

Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy

Clinical response rate will be calculated as proportion (responders/total patients).

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.

16S sequencing will be used to compare changes in stool microbiota.

Changes in clonal Ig will be used to assess changes in gammopathy.

Emory University

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rifaximin in Patients With Monoclonal Gammopathy	NCT03820817	IgA Monoclonal ... IgG Monoclonal ... IgM Monoclonal ... Light Chain Dep... Monoclonal Gamm... Smoldering Wald... Waldenstrom Mac... Gammopathy, Mon... Gammopathy Igg	Rifaximin	18 Years -	Emory University
Rifaximin in Patients With Monoclonal Gammopathy	NCT03820817	IgA Monoclonal ... IgG Monoclonal ... IgM Monoclonal ... Light Chain Dep... Monoclonal Gamm... Smoldering Wald... Waldenstrom Mac... Gammopathy, Mon... Gammopathy Igg	Rifaximin	18 Years -	Emory University

Spots Global Cancer Trial Database for smoldering waldenstrom macroglobulinemia