IgA Monoclonal Gammopathy of Undetermined Significance, Non-IgM Monoclonal Gammopathy of Undetermined Significance
Conditions
Brief summary
This phase II trial compares the effect of rifaximin to no intervention for the treatment of IgG/IgA monoclonal gammopathy of undetermined significance (MGUS). Rifaximin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill cancer cells or precancerous cells like those found with MGUS. Giving rifaximin may kill more precancerous cells in patients with IgG/IgA MGUS.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: 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. ARM B: Patients undergo blood sample collection throughout the study. After completion of study intervention, patients are followed up at 90 days.
Interventions
DRUGRifaximin
Given PO
PROCEDUREBiospecimen Collection
Undergo blood sample collection
Sponsors
Fred Hutchinson Cancer Center
Rising Tide Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants * Clinical diagnosis of IgG/IgA (non-IgM) monoclonal gammopathy of undetermined significance (MGUS) based on International Myeloma Working Group (IMWG)-2014 criteria (Rajkumar et al, Lancet Oncology, 2014). It is recognized that not all patients with clinical diagnosis of MGUS undergo bone marrow biopsy. Bone marrow biopsy confirmation will not be required if not clinically indicated per treating provider * Agree to use adequate contraception * For women of child-bearing potential: prior to study entry and for the duration of study participation * For men: prior to study entry, for the duration of study participation, and one month after completion of rifaximin administration (for men) * No antibiotic use in the preceding 2 weeks
Exclusion criteria
* Participants who are receiving other investigational agents * Pregnant women * Known hypersensitivity to rifaximin * Another concurrent malignancy requiring active therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | From the start of therapy, up to 90 days | Defined as the proportion of patients with \> 25% decline in clonal Ig at any point within 90 days after the initiation of drug or no intervention. Logistic regression will be conducted to evaluate the association between endpoint of interest and treatment (Arm A versus \[vs\] B). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients experiencing > grade 2 adverse events | From the start of therapy, up to 90 days | Logistic regression will be conducted to evaluate the association between endpoint of interest and treatment (Arm A vs B). |
Countries
United States
Contacts
CONTACTMadhav Dhodapkar, MBBS
PRINCIPAL_INVESTIGATORMadhav Dhodapkar, MBBS
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed