Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy.
SECONDARY OBJECTIVES:
I. To evaluate safety and tolerability of a 2-week course of rifaximin.
II. To evaluate changes in stool microbiota by 16S ribosomal ribonucleic acid (rRNA) gene (16S) sequencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (rifaximin)
Patients receive rifaximin PO TID on days 1-14 in the absence of disease progression or unacceptable toxicity.
干预措施: Rifaximin (Drug)
结局指标
主要结局
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%
时间窗: Up to 2 weeks after study start
Clinical response rate will be calculated as proportion (responders/total patients).
次要结局
- Changes in stool microbiota(Up to 12 weeks after study start)
- Changes in gammopathy(Up to 12 weeks after study start)
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0(Up to 12 weeks after study start)
研究者
Ajay Nooka
Principal Investigator
Emory University