Rifaximin for Monoclonal Gammopathy

Overseen By Madhav Dhodapkar, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Fred Hutchinson Cancer Center

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Hypersensitivity to rifaximin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the antibiotic rifaximin for individuals with IgA monoclonal gammopathy of undetermined significance (MGUS), a condition characterized by abnormal proteins in the blood. The goal is to determine if rifaximin can eliminate more precancerous cells compared to no treatment. Participants with a clinical diagnosis of IgA MGUS who have not used antibiotics in the last two weeks may be suitable for this study. The trial involves either taking rifaximin or receiving no treatment, with regular blood tests to monitor progress. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but you cannot have used antibiotics in the two weeks before starting the trial.

Is there any evidence suggesting that rifaximin is likely to be safe for humans?

Research has shown that rifaximin is usually well-tolerated. In past studies for other conditions, common side effects were mild, such as nausea and headache, occurring in about 10% of patients. Rifaximin, an antibiotic often used for stomach infections, has demonstrated a good safety record in those cases. Although using it to treat IgA monoclonal gammopathy is new, the ongoing phase 2 trial indicates it has passed earlier safety checks. This suggests it is safe enough for further testing, but it remains under study to confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for monoclonal gammopathy, which typically involve chemotherapy or corticosteroids, rifaximin offers a unique approach by targeting the gut microbiome. Rifaximin is an antibiotic that remains mostly in the gut, minimizing systemic side effects. Researchers are excited about rifaximin because it may modulate the immune response in a novel way, potentially reducing monoclonal protein levels without the harsh side effects of traditional therapies. This new mechanism of action makes rifaximin a promising candidate for managing monoclonal gammopathy more safely and comfortably.

What evidence suggests that rifaximin might be an effective treatment for IgA MGUS?

Research has shown that rifaximin might help lower the levels of abnormal proteins in people with IgA monoclonal gammopathy, a condition where the body produces too much of a specific protein. This antibiotic interferes with the DNA of harmful cells, potentially eliminating cancerous or precancerous cells. In this trial, participants in Arm A will receive rifaximin, while those in Arm B will undergo no intervention. Some studies suggest that rifaximin, compared to no treatment, could reduce these abnormal proteins or cells in the body. While there is interest in how rifaximin might help manage this condition, more research is needed to fully understand its effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

Madhav Dhodapkar, MBBS

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for individuals with IgA Monoclonal Gammopathy of Undetermined Significance (MGUS), a condition where abnormal proteins are found in the blood. Participants must meet specific health criteria to join, but these details were not provided.

Inclusion Criteria

I can understand and am willing to sign the consent form, or I have someone legally authorized to do so on my behalf.

I am 18 years old or older.

Agree to use adequate contraception for women of child-bearing potential prior to study entry and for the duration of study participation, and for men prior to study entry, for the duration of study participation, and one month after completion of rifaximin administration

Exclusion Criteria

Participants who are receiving other investigational agents

Pregnant women

Known hypersensitivity to rifaximin

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive rifaximin orally three times daily for 14 days or undergo no intervention, with blood sample collection throughout the study

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rifaximin

Trial Overview The study is testing if taking Rifaximin, an antibiotic that damages DNA in cells, can kill precancerous cells in patients with IgA MGUS compared to no treatment at all.

How Is the Trial Designed?

Group I: Arm B (No intervention) Experimental Treatment 1 Intervention

Patients undergo blood sample collection throughout the study.

Group II: Arm A (Rifaximin) Experimental Treatment 2 Interventions

Patients receive rifaximin orally (PO) three times daily (TID) for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Rising Tide Foundation

Collaborator

Trials

17

Recruited

6,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07209371

Rifaximin Versus No Intervention for the Treatment of IgA ... This phase II trial compares the effect of rifaximin to no intervention for the treatment of IgA monoclonal gammopathy of undetermined significance (MGUS).

2. withpower.com withpower.com/trial/phase-1-monoclonal-gammopathy-of-undetermined-significance-4-2019-075a7

Rifaximin for Monoclonal Gammopathy · Info for Participants DETAILED OUTCOME DATA - Rifaximin (Zaxine)Study 3001. RIFAXIMIN N = 140, PLACEB0 N = 159. Change in Conn Score. Increase, events at 6 months, 37, 77. Time ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2018-02106

Rifaximin 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10233333/

Monoclonal gammopathy of increasing significance We review the literature and case for MG screening in this paper. In particular, we highlight areas that require focus to establish screening for MG.

5. clinicaltrials.eu clinicaltrials.eu/inn/rifaximin/

Rifaximin: A Comprehensive Guide for Patients Monoclonal Gammopathy: A pilot study is evaluating the effects of rifaximin on patients with this blood disorder characterized by abnormal protein production.

6. trialx.com trialx.com/clinical-trials/listings/275344/rifaximin-in-patients-with-monoclonal-gammopathy/

Rifaximin in Patients With Monoclonal Gammopathy This trial studies how well rifaximin works in treating patients with monoclonal gammopathy. Antibiotics, such as rifaximin, may help to kill ...

7. go.drugbank.com go.drugbank.com/drugs/DB01220

Rifaximin: Uses, Interactions, Mechanism of Action Rifaximin is a rifamycin-based non-systemic antibiotic used for the treatment of gastrointestinal bacterial infections, such as traveler's diarrhea and ...