What side effects are associated with this type of intervention?

Rifaximin, an antibiotic used to treat monoclonal gammopathy by targeting intestinal bacteria, is generally well-tolerated but can cause side effects such as nausea, dizziness, and fatigue. Other common treatments for monoclonal gammopathy include immunomodulatory drugs like lenalidomide, which can lead to infections, fatigue, and gastrointestinal issues, and proteasome inhibitors like bortezomib, which may cause peripheral neuropathy, gastrointestinal disturbances, and hematologic toxicities. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically targeting intestinal bacteria to reduce abnormal proteins or cells in monoclonal gammopathy. However, treatments for related conditions like multiple myeloma often involve immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies. Examples include lenalidomide, bortezomib, and daratumumab. These treatments focus on reducing the proliferation of abnormal plasma cells rather than targeting intestinal bacteria.

What other types of research exist?

Promising novel alternatives to Rifaximin for treating monoclonal gammopathy include Daratumumab, a monoclonal antibody targeting CD38, which has shown efficacy in multiple myeloma and may benefit monoclonal gammopathy patients. Another option is Selinexor, a selective inhibitor of nuclear export, which has been effective in treating relapsed/refractory multiple myeloma. Both agents target the disease's underlying mechanisms and have shown promising results in clinical trials.

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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

Must not have

Patients who are receiving any other investigational agents for gammopathy. Patients with clinical myeloma requiring anti-myeloma therapy are also excluded

History of allergic reactions or intolerance attributed to rifaximin or compounds of similar chemical or biologic composition to antibiotic under study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 weeks after study start

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial studies how well rifaximin, an oral antibiotic, works in treating patients with monoclonal gammopathy. It aims to reduce abnormal blood proteins or cells by killing intestinal bacteria. Rifaximin has been used successfully for CDI treatment but lacks United States Food and Drug Administration approval for this indication.

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.

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.

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 below

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I have been diagnosed with a blood condition called MGUS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not on any experimental treatments for gammopathy and do not need therapy for clinical myeloma.

Select...

I am allergic to rifaximin or similar antibiotics.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 weeks after study start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%

Secondary study objectives

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 • NCT01842581

19%

Hepatic encephalopathy

17%

Oedema peripheral

16%

Constipation

14%

Nausea

14%

Fatigue

12%

Insomnia

11%

Urinary tract infection

10%

Pruritus generalised

Muscle spasms

Abdominal pain

Decreased appetite

Ascites

Dyspnoea

Headache

Cough

Renal failure acute

Vomiting

Asthenia

Anaemia

Anxiety

Jaundice

Diarrhoea

Abdominal distension

Cellulitis

Depression

Hyperkalaemia

Bronchitis

Peritonitis bacterial

Liver transplant

Gastrointestinal haemorrhage

Haematemesis

Non-cardiac chest pain

Pneumonia

Sepsis

Fluid overload

Hyperglycaemia

Acute respiratory failure

Herpes zoster

Cerebrovascular accident

Thrombocytopenia

Pneumococcal bacteraemia

Septic shock

Craniocerebral injury

Hepatic failure

Hepatitis

Hepatorenal syndrome

Toxic encephalopathy

Subarachnoid haemorrhage

Anxiety disorder

Suicidal ideation

Calculus ureteric

Oliguria

Renal failure

Pleural effusion

Flatulence

Cardiac failure congestive

Haematochezia

Upper gastrointestinal haemorrhage

Chest pain

Systemic inflammatory response syndrome

Chronic hepatic failure

Subdural haematoma

Dehydration

Alcoholic seizure

Hypovolaemic shock

100%

80%

60%

40%

20%

Study treatment Arm

Rifaximin 550 mg BID

Rifaximin 550 mg BID + Lactulose

Awards & Highlights

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.

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

0 / 3Eligibility criteria met

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?