Clinical trial NCT05824689: Fluoroquinolone Resistance Prevalence Study
Official title: Exploratory Study of Fluoroquinolone Resistance for Patients Undergoing Autologous Hematopoietic Stem Cell (HSC) Transplantation in the Treatment of Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Keywords: Myeloma, Plasma-Cell
Fluoroquinolone resistance
Autologous Hematopoietic Stem Cell Transplantation
Antibiotic Prophylaxis
Gut Microbiome
Febrile neutropenia
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects eligible for this study will meet the defined eligibility criteria to undergo autologous transplantation established at the transplant centers as per standard of care (SOC). All adult patients with a diagnosis of multiple myeloma undergoing autologous transplantation after dose-intense melphalan conditioning are candidates for enrollment into this study. These subjects will be approached for enrollment into this study by the transplant attending physician caring for the patient.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of FRE
timeFrame: Duration between Apheresis Consultation and Day +100
Secondary outcomes:
measure: Occurrence/Risk of Febrile Neutropenia (FN)
timeFrame: Within 28 days of the transplantation
measure: Occurrence/Risk of Blood Stream infection (BSI)
timeFrame: Within 28 days of the transplantation
measure: Comparison of severity of GI toxicity between FRE carriers and FRE non-carriers
timeFrame: Duration between Apheresis Consultation and Day +100
measure: Comparison of Length of Stay (LOS) between FRE carriers and FRE non-carriers
timeFrame: Duration between Day of hospital admission and Day of hospital discharge (estimated duration between 11 - 15 days)
measure: Comparison of Engraftment Kinetics between FRE carriers and FRE non-carriers
timeFrame: Duration between Apheresis Consultation and Day +100
Other outcomes:
measure: Comparison of effect of FRE colonization and fluoroquinolone prophylaxis on the microbiome between FRE carriers and FRE non-carriers
timeFrame: Duration between Apheresis Consultation and Day +100
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center, Georgetown University
state: District of Columbia
city: Hackensack
country: United States
facility: John Theurer Cancer Center, Hackensack Meridian Health
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Christina Cho, MD
role: PRINCIPAL_INVESTIGATOR
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