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Multiple MyelomaFRENCT05824689

Fluoroquinolone Resistance Prevalence Study

An observational study of Multiple Myeloma, run by Hackensack Meridian Health at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
How many people
124 participants
Where
2 sitesUnited States
Study dates
8 Jul 2022to 15 Jan 2025
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • John Theurer Cancer Center, Hackensack Meridian Health

    Hackensack, New Jersey, 07601

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Exploratory Study of Fluoroquinolone Resistance for Patients Undergoing Autologous Hematopoietic Stem Cell (HSC) Transplantation in the Treatment of Multiple Myeloma

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.

Read the 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).

Keywords
Myeloma, Plasma-Cell, Fluoroquinolone resistance, Autologous Hematopoietic Stem Cell Transplantation, Antibiotic Prophylaxis, Gut Microbiome, Febrile neutropenia
Medical subject headings
Multiple Myeloma, Febrile Neutropenia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of FRE

    Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan

    Measured: Duration between Apheresis Consultation and Day +100

Secondary outcomes (5)

  1. 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.

    Measured: Within 28 days of the transplantation

  2. Occurrence/Risk of Blood Stream Infection (BSI)

    The occurrence of Gram-negative BSI among the FRE carriers and FRE non-carriers

    Measured: Within 28 days of the transplantation

  3. 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

    Measured: Duration between Day of hospital admission and Day of hospital discharge (estimated duration between 11 - 15 days)

  4. 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

    Measured: Duration between Apheresis Consultation and Day +100

  5. 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

    Measured: Duration between Apheresis Consultation and Day +100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2023
  2. Study start8 Jul 2022
  3. Primary completion17 Dec 2024
  4. Study completion15 Jan 2025

Why it stopped: Discontinued Recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05824689
Sponsor's protocol ID
Pro2021-1263
Acronym
FRE
Status last verified
May 2026
First submitted
24 Mar 2023
Last updated
5 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gafter-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.

    PubMed 22258955

  • Satlin 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.

    PubMed 33956965

  • Centers 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.

    PubMed 11185897

  • Sorrig 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.

    PubMed 30485563

  • Satlin 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.

    PubMed 26150022

  • Savage 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.

    PubMed 6976144

  • Drayson MT, Bowcock S, Planche T, Iqbal G, Pratt G, Yong K, Wood J, Raynes K, Higgins H, Dawkins B, Meads D, Hulme CT, Monahan I, Karunanithi K, Dignum H, Belsham E, Neilson J, Harrison B, Lokare A, Campbell G, Hamblin M, Hawkey P, Whittaker AC, Low E, Dunn JA; TEAMM Trial Management Group and Trial Investigators. Levofloxacin prophylaxis in patients with newly diagnosed myeloma (TEAMM): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial. Lancet Oncol. 2019 Dec;20(12):1760-1772. doi: 10.1016/S1470-2045(19)30506-6. Epub 2019 Oct 23.

    PubMed 31668592

  • Sorrig R, Klausen TW, Salomo M, Vangsted A, Gimsing P. Risk factors for blood stream infections in multiple myeloma: A population-based study of 1154 patients in Denmark. Eur J Haematol. 2018 Jul;101(1):21-27. doi: 10.1111/ejh.13066. Epub 2018 May 4.

    PubMed 29569379

  • Jernigan JA, Hatfield KM, Wolford H, Nelson RE, Olubajo B, Reddy SC, McCarthy N, Paul P, McDonald LC, Kallen A, Fiore A, Craig M, Baggs J. Multidrug-Resistant Bacterial Infections in U.S. Hospitalized Patients, 2012-2017. N Engl J Med. 2020 Apr 2;382(14):1309-1319. doi: 10.1056/NEJMoa1914433.

    PubMed 32242356

  • Satlin MJ, Walsh TJ. Multidrug-resistant Enterobacteriaceae, Pseudomonas aeruginosa, and vancomycin-resistant Enterococcus: Three major threats to hematopoietic stem cell transplant recipients. Transpl Infect Dis. 2017 Dec;19(6):10.1111/tid.12762. doi: 10.1111/tid.12762. Epub 2017 Oct 25.

    PubMed 28815897

  • Spitzer TR. Engraftment syndrome following hematopoietic stem cell transplantation. Bone Marrow Transplant. 2001 May;27(9):893-8. doi: 10.1038/sj.bmt.1703015.

    PubMed 11436099

  • Maiolino A, Biasoli I, Lima J, Portugal AC, Pulcheri W, Nucci M. Engraftment syndrome following autologous hematopoietic stem cell transplantation: definition of diagnostic criteria. Bone Marrow Transplant. 2003 Mar;31(5):393-7. doi: 10.1038/sj.bmt.1703855.

    PubMed 12634731

  • Spitzer TR. Engraftment syndrome: double-edged sword of hematopoietic cell transplants. Bone Marrow Transplant. 2015 Apr;50(4):469-75. doi: 10.1038/bmt.2014.296. Epub 2015 Jan 12.

    PubMed 25581406

  • Gutierrez-Garcia G, Rovira M, Magnano L, Rosinol L, Bataller A, Suarez-Lledo M, Cibeira MT, de Larrea CF, Garrote M, Jorge S, Moreno A, Rodriguez-Lobato LG, Carreras E, Diaz-Ricart M, Palomo M, Martinez C, Urbano-Ispizua A, Blade J, Fernandez-Aviles F. Innovative strategies minimize engraftment syndrome in multiple myeloma patients with novel induction therapy following autologous hematopoietic stem cell transplantation. Bone Marrow Transplant. 2018 Dec;53(12):1541-1547. doi: 10.1038/s41409-018-0189-2. Epub 2018 Apr 29.

    PubMed 29706650

  • Chen J, Pan J, Zhan T, Tuazon S, Saini N, O'Hara W, Filicko-O'Hara J, Klumpp T, Kasner M, Carabasi M, Porcu P, Wagner JL. Autologous Stem Cell Transplantation for Multiple Myeloma: Growth Factor Matters. Biol Blood Marrow Transplant. 2019 Sep;25(9):e293-e297. doi: 10.1016/j.bbmt.2019.05.035. Epub 2019 Jun 4.

    PubMed 31173899

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Hackensack Meridian Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of FRE (time frame: Duration between Apheresis Consultation and Day +100). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05824689, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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