Multiple Myeloma
Conditions
Keywords
Myeloma, Plasma-Cell, Fluoroquinolone resistance, Autologous Hematopoietic Stem Cell Transplantation, Antibiotic Prophylaxis, Gut Microbiome, Febrile neutropenia
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).
Interventions
None listed
Sponsors
Hackensack Meridian Health
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of FRE | Duration between Apheresis Consultation and Day +100 | Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristina Cho, MD
Hackensack Meridian Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 56 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Age, Continuous | 64 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 86 Participants |
| Region of Enrollment United States | 117 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed