Clinical trial · Observational
Fluoroquinolone Resistance Prevalence Study
Exploratory Study of Fluoroquinolone Resistance for Patients Undergoing Autologous Hematopoietic Stem Cell (HSC) Transplantation in the Treatment of Multiple Myeloma
NCT05824689CI-TRIAL-00113749FREterminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Discontinued Recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of FRE
- timeFrame
- Duration between Apheresis Consultation and Day +100
- description
- Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan
Secondary outcomes (5)
- measure
- Occurrence/Risk of Febrile Neutropenia (FN)
- timeFrame
- Within 28 days of the transplantation
- description
- Occurrence of neutropenic fever during the first 28 days (4 weeks) after autologous PBSC transplantation in the treatment of multiple myeloma.
- measure
- Occurrence/Risk of Blood Stream Infection (BSI)
- timeFrame
- Within 28 days of the transplantation
- description
- The occurrence of Gram-negative BSI among the FRE carriers and FRE non-carriers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (28)
- BACKGROUNDGafter-Gvili A, Fraser A, Paul M, Vidal L, Lawrie TA, van de Wetering MD, Kremer LC, Leibovici L. Antibiotic prophylaxis for bacterial infections in afebrile neutropenic patients following chemotherapy. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD004386. doi: 10.1002/14651858.CD004386.pub3. PMID 22258955
- BACKGROUNDSatlin MJ, Chen L, Douglass C, Hovan M, Davidson E, Soave R, La Spina M, Gomez-Arteaga A, van Besien K, Mayer S, Phillips A, Hsu JM, Malherbe R, Small CB, Jenkins SG, Westblade LF, Kreiswirth BN, Walsh TJ. Colonization With Fluoroquinolone-Resistant Enterobacterales Decreases the Effectiveness of Fluoroquinolone Prophylaxis in Hematopoietic Cell Transplant Recipients. Clin Infect Dis. 2021 Oct 5;73(7):1257-1265. doi: 10.1093/cid/ciab404. PMID 33956965
- BACKGROUNDCenters for Disease Control and Prevention; Infectious Diseases Society of America; American Society of Blood and Marrow Transplantation. Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients. Biol Blood Marrow Transplant. 2000;6(6a):7-83. doi: 10.1016/s1083-8791(00)70002-4. PMID 11185897
- BACKGROUNDSorrig R, Klausen TW, Salomo M, Vangsted A, Gimsing P. Risk factors for infections in newly diagnosed Multiple Myeloma patients: A Danish retrospective nationwide cohort study. Eur J Haematol. 2019 Feb;102(2):182-190. doi: 10.1111/ejh.13190. Epub 2018 Nov 28. PMID 30485563
- BACKGROUNDSatlin MJ, Vardhana S, Soave R, Shore TB, Mark TM, Jacobs SE, Walsh TJ, Gergis U. Impact of Prophylactic Levofloxacin on Rates of Bloodstream Infection and Fever in Neutropenic Patients with Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2015 Oct;21(10):1808-14. doi: 10.1016/j.bbmt.2015.06.017. Epub 2015 Jul 3. PMID 26150022
- BACKGROUNDSavage DG, Lindenbaum J, Garrett TJ. Biphasic pattern of bacterial infection in multiple myeloma. Ann Intern Med. 1982 Jan;96(1):47-50. doi: 10.7326/0003-4819-96-1-47.