Rifaximin in Patients With Monoclonal Gammopathy

Overview

This trial studies how well rifaximin works 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.

SparkCures ID 1008
Trial Phase Phase 1
Enrollment 48 Patients
Treatments
  • Rifaximin
Trial Sponsors
  • Winship Cancer Institute of Emory University
Trial Collaborators
  • Leukemia and Lymphoma Society
NCT Identifier

NCT03820817

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • 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:
    • Cohort A: IgA gammopathy
    • Cohort B: IgG gammopathy / or light chain gammopathy
    • Cohort C: IgM gammopathy / asymptomatic macroglobulinemia
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have received antibiotics within last 3 weeks
  • 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
  • The effects of rifaximin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of rifaximin administration

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Winship Cancer Institute of Emory University -

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Georgia
Verified Winship Cancer Institute of Emory University -

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Resources

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