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Trial Title:
Fluoroquinolone Resistance Prevalence Study
NCT ID:
NCT05824689
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Myeloma, Plasma-Cell
Fluoroquinolone resistance
Autologous Hematopoietic Stem Cell Transplantation
Antibiotic Prophylaxis
Gut Microbiome
Febrile neutropenia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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).
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lombardi Comprehensive Cancer Center, Georgetown University
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eliza Keller
Phone:
202-784-0038
Email:
ek952@georgetown.edu
Facility:
Name:
John Theurer Cancer Center, Hackensack Meridian Health
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariefel Vendivil, RN
Phone:
551-996-5828
Email:
mariefel.vendevil@hmhn.org
Start date:
July 8, 2022
Completion date:
April 2025
Lead sponsor:
Agency:
Hackensack Meridian Health
Agency class:
Other
Source:
Hackensack Meridian Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05824689
https://www.nccn.org
