Trials Sponsors Conditions Drugs Pricing

Conditions

Gammopathy Igg Gammopathy, Monoclonal IgA Monoclonal Gammopathy IgG Monoclonal Gammopathy IgM Monoclonal Gammopathy Light Chain Deposition Disease Monoclonal Gammopathy Smoldering Waldenstrom Macroglobulinemia Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Clinical response rate will be calculated as proportion (responders/total patients).
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
Up to 12 weeks after study start
Changes in stool microbiota
Up to 12 weeks after study start

Study Arms (1)

Treatment (rifaximin)

EXPERIMENTAL

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

Drug: Rifaximin

Interventions

RifaximinDrug

Given PO

Also known as: Xifaxan

Treatment (rifaximin)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:

Sponsors & Collaborators

Emory University
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

MeSH Terms

Conditions

ParaproteinemiasWaldenstrom Macroglobulinemia

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Blood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular Diseases

Study Officials

Ajay Nooka, MD
Emory University
PRINCIPAL INVESTIGATOR

Enrollment

50 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 29, 2019

Study Start

May 15, 2019

Actual (reported)

Rifaximin in Patients With Monoclonal Gammopathy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Treatment (rifaximin)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Treatment (rifaximin)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations