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.
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 Type
OBSERVATIONAL
Enrollment
124
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States
John Theurer Cancer Center, Hackensack Meridian Health
Hackensack, New Jersey, United States
Prevalence of FRE
Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan
Time frame: Duration between Apheresis Consultation and Day +100
Occurrence/Risk of Febrile Neutropenia (FN)
Occurrence of neutropenic fever during the first 28 days (4 weeks) after autologous PBSC transplantation in the treatment of multiple myeloma.
Time frame: Within 28 days of the transplantation
Occurrence/Risk of Blood Stream Infection (BSI)
The occurrence of Gram-negative BSI among the FRE carriers and FRE non-carriers
Time frame: Within 28 days of the transplantation
Comparison of Length of Stay (LOS) Between FRE Carriers and FRE Non-carriers
Comparison of Length of Stay (LOS) between FRE carriers and FRE non-carriers by estimating time to discharge
Time frame: 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
Comparison of Engraftment Kinetics (absolute neutrophil count (ANC), absolute lymphocyte count (ALC), platelet) between FRE carriers and FRE non-carriers
Time frame: Duration between Apheresis Consultation and Day +100
Comparison of Severity of GI Toxicity Between FRE Carriers and FRE Non-carriers
Comparison of severity of GI toxicity between FRE carriers and FRE non-carriers per the grade of GI toxicity
Time frame: Duration between Apheresis Consultation and Day +100
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