Trial Outcomes & Findings for Fluoroquinolone Resistance Prevalence Study (NCT NCT05824689)
NCT ID: NCT05824689
Last Updated: 2026-06-05
Results Overview
Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan
Recruitment status
TERMINATED
Target enrollment
124 participants
Primary outcome timeframe
Duration between Apheresis Consultation and Day +100
Results posted on
2026-06-05
Participant Flow
Participant milestones
| Measure |
Enrolled Participants
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
|
|---|---|
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Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
|
117
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Enrolled Participants
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
|
|---|---|
|
Overall Study
Did Not Proceed to Transplantation
|
7
|
Baseline Characteristics
Fluoroquinolone Resistance Prevalence Study
Baseline characteristics by cohort
| Measure |
Enrolled Participants
n=117 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=20 Participants
|
|
Age, Continuous
|
64 Years
n=20 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Duration between Apheresis Consultation and Day +100Population: Based on Samples Provided at Specific Timepoints
Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan
Outcome measures
| Measure |
Enrolled Participants
n=117 Participants
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
|
FRE Positive
FRE Positive Participants
|
|---|---|---|
|
Prevalence of FRE
Pre-CDE mobilization
|
11 Participants
|
—
|
|
Prevalence of FRE
Pre-transplant
|
23 Participants
|
—
|
|
Prevalence of FRE
Hosp discharge
|
29 Participants
|
—
|
|
Prevalence of FRE
Day 100
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 28 days of the transplantationPopulation: Analysis separated by FRE Positive and Negative Participants
Occurrence of neutropenic fever during the first 28 days (4 weeks) after autologous PBSC transplantation in the treatment of multiple myeloma.
Outcome measures
| Measure |
Enrolled Participants
n=117 Participants
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
|
FRE Positive
FRE Positive Participants
|
|---|---|---|
|
Occurrence/Risk of Febrile Neutropenia (FN)
FRE Neg Participants
|
22 Participants
|
—
|
|
Occurrence/Risk of Febrile Neutropenia (FN)
FRE Positive Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 28 days of the transplantationThe occurrence of Gram-negative BSI among the FRE carriers and FRE non-carriers
Outcome measures
| Measure |
Enrolled Participants
n=117 Participants
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
|
FRE Positive
FRE Positive Participants
|
|---|---|---|
|
Occurrence/Risk of Blood Stream Infection (BSI)
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Enrolled Participants
n=69 Participants
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
|
FRE Positive
n=48 Participants
FRE Positive Participants
|
|---|---|---|
|
Comparison of Length of Stay (LOS) Between FRE Carriers and FRE Non-carriers
|
13 Hospitalization duration (Days)
Interval 12.0 to 14.0
|
13 Hospitalization duration (Days)
Interval 12.0 to 16.0
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SECONDARY outcome
Timeframe: Duration between Apheresis Consultation and Day +100Comparison of Engraftment Kinetics (absolute neutrophil count (ANC), absolute lymphocyte count (ALC), platelet) between FRE carriers and FRE non-carriers
Outcome measures
| Measure |
Enrolled Participants
n=69 Participants
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
|
FRE Positive
n=48 Participants
FRE Positive Participants
|
|---|---|---|
|
Comparison of Engraftment Kinetics Between FRE Carriers and FRE Non-carriers
ANC
|
11 Engraftment (Days)
Interval 10.0 to 11.0
|
11 Engraftment (Days)
Interval 11.0 to 11.0
|
|
Comparison of Engraftment Kinetics Between FRE Carriers and FRE Non-carriers
Platelet
|
13 Engraftment (Days)
Interval 11.0 to 14.0
|
13 Engraftment (Days)
Interval 11.0 to 15.0
|
SECONDARY outcome
Timeframe: Duration between Apheresis Consultation and Day +100Population: Subject pre-transplant sample
Comparison of severity of GI toxicity between FRE carriers and FRE non-carriers per the grade of GI toxicity
Outcome measures
| Measure |
Enrolled Participants
n=63 Participants
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
|
FRE Positive
n=10 Participants
FRE Positive Participants
|
|---|---|---|
|
Comparison of Severity of GI Toxicity Between FRE Carriers and FRE Non-carriers
Documented Engraftment Syndrome
|
14 Participants
|
3 Participants
|
|
Comparison of Severity of GI Toxicity Between FRE Carriers and FRE Non-carriers
No Documented Engraftment Syndrome
|
49 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration between Apheresis Consultation and Day +100Comparison of effect of FRE colonization and fluoroquinolone prophylaxis on the microbiome between FRE carriers and FRE non-carriers
Outcome measures
Outcome data not reported
Adverse Events
Enrolled Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place