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Antibiotic
Rifaximin for Monoclonal Gammopathy
Phase 1
Recruiting
Led By Madhav Dhodapkar, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of monoclonal gammopathy of undetermined significance based on International Myeloma Working Group (IMWG) criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks after study start
Awards & highlights
Study Summary
This trial is testing how well rifaximin works to treat patients with monoclonal gammopathy by reducing the abnormal protein or cells in patients.
Who is the study for?
This trial is for individuals with monoclonal gammopathy, a condition where abnormal proteins are produced by the immune system. Participants must understand and sign consent, not have received antibiotics in the last 3 weeks or be on other investigational treatments for gammopathy. Women of childbearing potential and men must use contraception during and after the trial.Check my eligibility
What is being tested?
The study is testing rifaximin, an antibiotic thought to reduce bacteria in the intestines that may be linked to monoclonal gammopathy. The goal is to see if it can decrease abnormal proteins or cells associated with this condition.See study design
What are the potential side effects?
Rifaximin could cause side effects like digestive issues (nausea, bloating), allergic reactions in those sensitive to its components, headaches, dizziness, fatigue, and changes in blood tests related to liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a blood condition called MGUS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 weeks after study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks after study start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
Secondary outcome measures
Changes in gammopathy
Changes in stool microbiota
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Side effects data
From 2014 Phase 4 trial • 222 Patients • NCT0184258119%
Hepatic encephalopathy
17%
Oedema peripheral
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Insomnia
11%
Urinary tract infection
10%
Pruritus generalised
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Bronchitis
2%
Peritonitis bacterial
2%
Hyperkalaemia
2%
Liver transplant
1%
Acute respiratory failure
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Fluid overload
1%
Hyperglycaemia
1%
Non-cardiac chest pain
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Pneumonia
1%
Sepsis
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin 550 mg BID
Rifaximin 550 mg BID + Lactulose
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (rifaximin)Experimental Treatment1 Intervention
Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Monoclonal Gammopathy include antibiotics like Rifaximin, which target and kill intestinal bacteria to potentially reduce abnormal proteins or cells. Immunomodulatory drugs (e.g., thalidomide, lenalidomide) enhance the immune system's ability to fight abnormal cells.
Proteasome inhibitors (e.g., bortezomib) disrupt protein degradation in cancer cells, leading to cell death. Corticosteroids reduce inflammation and suppress immune responses.
Monoclonal antibodies (e.g., daratumumab) target specific proteins on cancer cells, marking them for destruction by the immune system. These treatments are crucial as they address different aspects of the disease, potentially reducing the abnormal protein levels and improving patient outcomes.
Rifaximin as a Potential Treatment for IgA Nephropathy in a Humanized Mice Model.The emerging role of rituximab in autoimmune blistering diseases.Monoclonal antibody therapy in multiple myeloma: where do we stand and where are we going?
Rifaximin as a Potential Treatment for IgA Nephropathy in a Humanized Mice Model.The emerging role of rituximab in autoimmune blistering diseases.Monoclonal antibody therapy in multiple myeloma: where do we stand and where are we going?
Find a Location
Who is running the clinical trial?
The Leukemia and Lymphoma SocietyOTHER
82 Previous Clinical Trials
17,083 Total Patients Enrolled
1 Trials studying Monoclonal Gammopathy
42 Patients Enrolled for Monoclonal Gammopathy
Emory UniversityLead Sponsor
1,650 Previous Clinical Trials
2,572,606 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
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (rifaximin)
Awards:
This trial has 3 awards, including:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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