Fluoroquinolone Resistance Prevalence Study (FRE)

Hackensack Meridian Health

Status: Terminated

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Other

Identifiers

NCT05824689

2021-1263

Details and patient eligibility

About

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.

Full description

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.

This study will be open at two transplant units: Hackensack University Medical Center (HUMC) and MedStar Georgetown University Hospital (MGUH). Estimated number of subjects to be enrolled;

• HUMC: 124
• MGUH: 20

Anticipated enrollment period: 12-months with monitoring of subjects for 84 days (twelve weeks) after transplantation. Data will be analyzed over a three-month period (total study period of 18 months).

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects >18 yrs of age.
• Diagnosis of multiple myeloma undergoing (first or subsequent) autologous PBSC transplantation.
• Transplant conditioning with melphalan 200 mg/m2.
• PBSC cell dose of >2x10e6 CD34+ cells/kg.
• Able to receive fluoroquinolone prophylaxis.
• Subjects must give consent for enrollment into this study.

Exclusion criteria

• 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/m2.
• Known light-chain amyloid deposition in any organ.