Rifaximin Versus No Intervention in Patients With IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participants who are receiving other investigational agents
- •Pregnant women
- •Known hypersensitivity to rifaximin
- •Another concurrent malignancy requiring active therapy
研究组 & 干预措施
Arm A (Rifaximin)
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.
干预措施: Rifaximin (Drug)
Arm B (No intervention)
Patients undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm A (Rifaximin)
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.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Overall response rate
时间窗: 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).
次要结局
- Proportion of patients experiencing > grade 2 adverse events(From the start of therapy, up to 90 days)