This trial is testing how well rifaximin works to treat patients with monoclonal gammopathy by reducing the abnormal protein or cells in patients.
- Monoclonal Gammopathy
- Waldenstrom Macroglobulinemia
- Smoldering Waldenstrom Macroglobulinemia
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Light Chain Deposition Disease
- Immunoglobulin A Monoclonal Gammopathy
1 Primary · 3 Secondary · Reporting Duration: Up to 2 weeks after study start
Changes in gammopathy
Changes in stool microbiota
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Side Effects for
Rifaximin 550 mg BID
11%Urinary tract infection
5%Renal failure acute
1%Non-cardiac chest pain
1%Cardiac failure congestive
1%Upper gastrointestinal haemorrhage
1%Systemic inflammatory response syndrome
1%Chronic hepatic failure
1%Acute respiratory failure
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01842581) in the Rifaximin 550 mg BID ARM group. Side effects include: Hepatic encephalopathy with 19%, Oedema peripheral with 17%, Constipation with 16%, Nausea with 14%, Fatigue with 14%.
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
1 Treatment Group
1 of 1
48 Total Participants · 1 Treatment Group
Primary Treatment: Rifaximin · No Placebo Group · Phase 1
DrugExperimental Group · 1 Intervention: Rifaximin · Intervention Types: Drug
Drug Approval Stage
How many patients have taken this drug
Screening: ~3 weeks
Reporting: up to 2 weeks after study start
Who is running the clinical trial?
The Leukemia and Lymphoma SocietyOTHER
75 Previous Clinical Trials
16,752 Total Patients Enrolled
1 Trials studying Monoclonal Gammopathy
42 Patients Enrolled for Monoclonal Gammopathy
Emory UniversityLead Sponsor
1,558 Previous Clinical Trials
2,765,693 Total Patients Enrolled
Madhav Dhodapkar, MDPrincipal Investigator - Emory University
Emory University Hospital, Emory University Hospital Midtown
All India Inst Of Medical Sci (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
4 Previous Clinical Trials
390 Total Patients Enrolled
Age 18+ · All Participants · 0 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
|Emory University Hospital/Winship Cancer Institute||100.0%|
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Emory University Hospital/Winship Cancer Institute: < 48 hours
Average response time
- < 2 Days