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

Neoplasm, Residual

Part of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample)

Patient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques

MRD and clonal evolution

Marzia Varettoni

Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques.

Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques such as flow cytometry, real time quantitative PCR (RT-qPCR), digital droplet PCR (dd-PCR) and NGS, in order to: evaluate the mutational status on genomic DNA or cell-free DNA and compare the results to assess the most reliable source for mutation studies; perform and compare molecular and flow cytometry analyses on bone marrow, peripheral blood (both analyses), plasma and urine samples (only molecular analysis) to assess the best source for diagnosis and MRD monitoring.

Peripheral blood, Bone marrow and Urine collected at Baseline, Before treatment, after treatment, at 12 months follow up, at 24 months follow up and at 60 months follow up

Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS

Non-invasive Diagnostics and Monitoring of Minimal Residual Disease and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM Monoclonal Gammopathy of Undetermined Significance

To demonstrate that the rate of mutations of MYD88 (L265P) and/or CXCR4 (S338X) detected in peripheral blood and/or urine show a negligible difference with the rate of mutations detected in bone marrow samples (BM, gold standard)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS	NCT03521596	Waldenstrom Mac...	MRD and clonal ...	18 Years -	Fondazione Italiana Linfomi - ETS
Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS	NCT03521596	Waldenstrom Mac...	MRD and clonal ...	18 Years -	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for igm monoclonal gammopathy