Exploratory Study of Fluoroquinolone Resistance for Patients Undergoing Autologous Hematopoietic Stem Cell (HSC) Transplantation in the Treatment of Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Prevalence of FRE
研究概览
简要总结
This is an exploratory study to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM).
These data may be used in subsequent studies exploring the use of prophylaxis in this patient population.
详细描述
The goal of this observational study is to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM).
The main question[s] it aims to answer are:
- What is the prevalence of fluoroquinolone-resistant Enterobacterales (FRE) in patients undergoing autologous PBSC transplantation with dose-intense melphalan?
- Does the risk of febrile neutropenia differ in FRE carriers compared to non-carriers?
Participants will be tested for the presence of FRE before receiving fluoroquinolone prophylaxis at multiple points during the transplant course, including before chemotherapy mobilization (if used) using fluoroquinolone prophylaxis, at initial transplant hospitalization, at time of hospital discharge, and at or after day 84 after transplantation (day 0 is defined as day of HSC (hematopoietic stem cell) infusion).
FRE colonization will not be a determining factor in the use of fluoroquinolone prophylaxis during the treatment course.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subjects >18 yrs of age.
- •Diagnosis of multiple myeloma undergoing (first or subsequent) autologous PBSC transplantation.
- •Transplant conditioning with melphalan 200 mg/m
- •PBSC cell dose of >2x10e6 CD34+ cells/kg.
- •Able to receive fluoroquinolone prophylaxis.
- •Subjects must give consent for enrollment into this study.
排除标准
- •Unwillingness to provide informed consent.
- •Enrollment into a treatment protocol prescribing antibiotic prophylaxis.
- •A diagnosis other than multiple myeloma.
- •Receiving a conditioning regimen other than melphalan 200 mg/m
- •Known light-chain amyloid deposition in any organ.
结局指标
主要结局
Prevalence of FRE
时间窗: Duration between Apheresis Consultation and Day +100
Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan
次要结局
- Occurrence/Risk of Febrile Neutropenia (FN)(Within 28 days of the transplantation)
- Occurrence/Risk of Blood Stream infection (BSI)(Within 28 days of the transplantation)
- Comparison of severity of GI toxicity between FRE carriers and FRE non-carriers(Duration between Apheresis Consultation and Day +100)
- Comparison of Length of Stay (LOS) between FRE carriers and FRE non-carriers(Duration between Day of hospital admission and Day of hospital discharge (estimated duration between 11 - 15 days))
- Comparison of Engraftment Kinetics between FRE carriers and FRE non-carriers(Duration between Apheresis Consultation and Day +100)