FRE: Fluoroquinolone Resistance Prevalence Study

Sponsor

Hackensack Meridian Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05824689

Collaborator

(none)

144

Enrollment

Locations

20.8

Anticipated Duration (Months)

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma

Detailed 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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

144 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Exploratory Study of Fluoroquinolone Resistance for Patients Undergoing Autologous Hematopoietic Stem Cell (HSC) Transplantation in the Treatment of Multiple Myeloma

Actual Study Start Date :

Jul 8, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Outcome Measures

Primary Outcome Measures

Prevalence of FRE [Duration between Apheresis Consultation and Day +100]
Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan

Secondary Outcome Measures

Occurrence/Risk of Febrile Neutropenia (FN) [Within 28 days of the transplantation]
Occurrence of neutropenic fever during the first 28 days (4 weeks) after autologous PBSC transplantation in the treatment of multiple myeloma.
Occurrence/Risk of Blood Stream infection (BSI) [Within 28 days of the transplantation]
The occurrence of Gram-negative BSI among the FRE carriers and FRE non-carriers
Comparison of severity of GI toxicity between FRE carriers and FRE non-carriers [Duration between Apheresis Consultation and Day +100]
Comparison of severity of GI toxicity between FRE carriers and FRE non-carriers per the grade of GI toxicity
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 Length of Stay (LOS) between FRE carriers and FRE non-carriers by estimating time to discharge
Comparison of Engraftment Kinetics between FRE carriers and FRE non-carriers [Duration between Apheresis Consultation and Day +100]
Comparison of Engraftment Kinetics (absolute neutrophil count (ANC), absolute lymphocyte count (ALC), platelet) between FRE carriers and FRE non-carriers

Other Outcome Measures

Comparison of effect of FRE colonization and fluoroquinolone prophylaxis on the microbiome between FRE carriers and FRE non-carriers [Duration between Apheresis Consultation and Day +100]
Comparison of effect of FRE colonization and fluoroquinolone prophylaxis on the microbiome between FRE carriers and FRE non-carriers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lombardi Comprehensive Cancer Center, Georgetown University	Washington	District of Columbia	United States	20007
2	John Theurer Cancer Center, Hackensack Meridian Health	Hackensack	New Jersey	United States	07601