Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Discontinued Recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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;
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of FRE | Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan | Duration between Apheresis Consultation and Day +100 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 28 days of the transplantation |
| Occurrence/Risk of Blood Stream Infection (BSI) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Effect of FRE Colonization and Fluoroquinolone Prophylaxis on the Microbiome Between FRE Carriers and FRE Non-carriers | Comparison of effect of FRE colonization and fluoroquinolone prophylaxis on the microbiome between FRE carriers and FRE non-carriers | Duration between Apheresis Consultation and Day +100 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christina Cho, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center, Georgetown University | Washington D.C. | District of Columbia | 20007 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22258955 | Background | 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. | |
| 33956965 | Background |
| Label | URL |
|---|---|
| Prevention and Treatment of Cancer-Related Infections, Version: 2.2020 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of FRE | Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan | Based on Samples Provided at Specific Timepoints | Posted | Count of Participants | Participants | Duration between Apheresis Consultation and Day +100 |
|
Not applicable for this observational study
Not applicable for this observational study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Zenreich | Hackensack Meridian Health | 551-996-4248 | joshua.zenreich@hmhn.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2023 | Feb 17, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
The occurrence of Gram-negative BSI among the FRE carriers and FRE non-carriers |
| 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 | 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 | 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 | Duration between Apheresis Consultation and Day +100 |
| John Theurer Cancer Center, Hackensack Meridian Health |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| 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. |
| 11185897 | Background | 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. |
| 30485563 | Background | 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. |
| 26150022 | Background | 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. |
| 6976144 | Background | 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. |
| 31668592 | Background | 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. |
| 29569379 | Background | 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. |
| 32242356 | Background | 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. |
| 28815897 | Background | 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. |
| 11436099 | Background | Spitzer TR. Engraftment syndrome following hematopoietic stem cell transplantation. Bone Marrow Transplant. 2001 May;27(9):893-8. doi: 10.1038/sj.bmt.1703015. |
| 12634731 | Background | 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. |
| 25581406 | Background | 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. |
| 29706650 | Background | 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. |
| 31173899 | Background | 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. |
| 8932849 | Background | Ravoet C, Feremans W, Husson B, Majois F, Kentos A, Lambermont M, Wallef G, Capel P, Beauduin M, Delannoy A. Clinical evidence for an engraftment syndrome associated with early and steep neutrophil recovery after autologous blood stem cell transplantation. Bone Marrow Transplant. 1996 Nov;18(5):943-7. |
| 18762759 | Background | Drobyski WR, Hari P, Keever-Taylor C, Komorowski R, Grossman W. Severe autologous GVHD after hematopoietic progenitor cell transplantation for multiple myeloma. Bone Marrow Transplant. 2009 Jan;43(2):169-77. doi: 10.1038/bmt.2008.295. Epub 2008 Sep 1. |
| 26327628 | Background | Cornell RF, Hari P, Drobyski WR. Engraftment Syndrome after Autologous Stem Cell Transplantation: An Update Unifying the Definition and Management Approach. Biol Blood Marrow Transplant. 2015 Dec;21(12):2061-2068. doi: 10.1016/j.bbmt.2015.08.030. Epub 2015 Aug 29. |
| 33147257 | Background | Rodriguez-Lobato LG, Martinez-Roca A, Castano-Diez S, Palomino-Mosquera A, Gutierrez-Garcia G, Pedraza A, Suarez-Lledo M, Rovira M, Martinez C, Fernandez de Larrea C, Cibeira MT, Rosinol L, Lozano E, Marin P, Cid J, Lozano M, Moreno-Castano AB, Palomo M, Diaz-Ricart M, Gallego C, Hernando A, Segura S, Carreras E, Urbano-Ispizua A, Blade J, Fernandez-Aviles F. The avoidance of G-CSF and the addition of prophylactic corticosteroids after autologous stem cell transplantation for multiple myeloma patients appeal for the at-home setting to reduce readmission for neutropenic fever. PLoS One. 2020 Nov 4;15(11):e0241778. doi: 10.1371/journal.pone.0241778. eCollection 2020. |
| 32979278 | Background | Betticher C, Bacher U, Legros M, Zimmerli S, Banz Y, Mansouri Taleghani B, Pabst T. Prophylactic corticosteroid use prevents engraftment syndrome in patients after autologous stem cell transplantation. Hematol Oncol. 2021 Feb;39(1):97-104. doi: 10.1002/hon.2813. Epub 2020 Oct 3. |
| 29449660 | Background | Shono Y, van den Brink MRM. Gut microbiota injury in allogeneic haematopoietic stem cell transplantation. Nat Rev Cancer. 2018 May;18(5):283-295. doi: 10.1038/nrc.2018.10. Epub 2018 Feb 16. |
| 33882637 | Background | Van Lier YF, Van den Brink MRM, Hazenberg MD, Markey KA. The post-hematopoietic cell transplantation microbiome: relationships with transplant outcome and potential therapeutic targets. Haematologica. 2021 Aug 1;106(8):2042-2053. doi: 10.3324/haematol.2020.270835. |
| 28296584 | Background | Peled JU, Devlin SM, Staffas A, Lumish M, Khanin R, Littmann ER, Ling L, Kosuri S, Maloy M, Slingerland JB, Ahr KF, Porosnicu Rodriguez KA, Shono Y, Slingerland AE, Docampo MD, Sung AD, Weber D, Alousi AM, Gyurkocza B, Ponce DM, Barker JN, Perales MA, Giralt SA, Taur Y, Pamer EG, Jenq RR, van den Brink MRM. Intestinal Microbiota and Relapse After Hematopoietic-Cell Transplantation. J Clin Oncol. 2017 May 20;35(15):1650-1659. doi: 10.1200/JCO.2016.70.3348. Epub 2017 Mar 15. |
| 23649557 | Background | Samet A, Sledzinska A, Krawczyk B, Hellmann A, Nowicki S, Kur J, Nowicki B. Leukemia and risk of recurrent Escherichia coli bacteremia: genotyping implicates E. coli translocation from the colon to the bloodstream. Eur J Clin Microbiol Infect Dis. 2013 Nov;32(11):1393-400. doi: 10.1007/s10096-013-1886-9. Epub 2013 May 7. |
| 34513724 | Background | Innes AJ, Mullish BH, Ghani R, Szydlo RM, Apperley JF, Olavarria E, Palanicawandar R, Kanfer EJ, Milojkovic D, McDonald JAK, Brannigan ET, Thursz MR, Williams HRT, Davies FJ, Marchesi JR, Pavlu J. Fecal Microbiota Transplant Mitigates Adverse Outcomes Seen in Patients Colonized With Multidrug-Resistant Organisms Undergoing Allogeneic Hematopoietic Cell Transplantation. Front Cell Infect Microbiol. 2021 Aug 27;11:684659. doi: 10.3389/fcimb.2021.684659. eCollection 2021. |
| 33654104 | Background | Liao C, Taylor BP, Ceccarani C, Fontana E, Amoretti LA, Wright RJ, Gomes ALC, Peled JU, Taur Y, Perales MA, van den Brink MRM, Littmann E, Pamer EG, Schluter J, Xavier JB. Compilation of longitudinal microbiota data and hospitalome from hematopoietic cell transplantation patients. Sci Data. 2021 Mar 2;8(1):71. doi: 10.1038/s41597-021-00860-8. |
| 30959164 | Background | El Jurdi N, Filali-Mouhim A, Salem I, Retuerto M, Dambrosio NM, Baer L, Lazarus HM, Caimi P, Cooper B, Tomlinson B, Metheny L, Malek E, Otegbeye F, Sekaly RP, Ghannoum M, de Lima M. Gastrointestinal Microbiome and Mycobiome Changes during Autologous Transplantation for Multiple Myeloma: Results of a Prospective Pilot Study. Biol Blood Marrow Transplant. 2019 Aug;25(8):1511-1519. doi: 10.1016/j.bbmt.2019.04.007. Epub 2019 Apr 5. |
| 33512409 | Background | Khan N, Lindner S, Gomes ALC, Devlin SM, Shah GL, Sung AD, Sauter CS, Landau HJ, Dahi PB, Perales MA, Chung DJ, Lesokhin AM, Dai A, Clurman A, Slingerland JB, Slingerland AE, Brereton DG, Giardina PA, Maloy M, Armijo GK, Rondon-Clavo C, Fontana E, Bohannon L, Ramalingam S, Bush AT, Lew MV, Messina JA, Littmann E, Taur Y, Jenq RR, Chao NJ, Giralt S, Markey KA, Pamer EG, van den Brink MRM, Peled JU. Fecal microbiota diversity disruption and clinical outcomes after auto-HCT: a multicenter observational study. Blood. 2021 Mar 18;137(11):1527-1537. doi: 10.1182/blood.2020006923. |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Analysis separated by FRE Positive and Negative Participants | Posted | Count of Participants | Participants | Within 28 days of the transplantation |
|
|
|
| Secondary | Occurrence/Risk of Blood Stream Infection (BSI) | The occurrence of Gram-negative BSI among the FRE carriers and FRE non-carriers | Posted | Count of Participants | Participants | Within 28 days of the transplantation |
|
|
|
| Secondary | 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 | Posted | Median | Full Range | Hospitalization duration (Days) | Duration between Day of hospital admission and Day of hospital discharge (estimated duration between 11 - 15 days) |
|
|
|
| Secondary | 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 | Posted | Median | Full Range | Engraftment (Days) | Duration between Apheresis Consultation and Day +100 |
|
|
|
| Secondary | 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 | Subject pre-transplant sample | Posted | Count of Participants | Participants | Duration between Apheresis Consultation and Day +100 |
|
|
|
| Other Pre-specified | Comparison of Effect of FRE Colonization and Fluoroquinolone Prophylaxis on the Microbiome Between FRE Carriers and FRE Non-carriers | Comparison of effect of FRE colonization and fluoroquinolone prophylaxis on the microbiome between FRE carriers and FRE non-carriers | Not Posted | Duration between Apheresis Consultation and Day +100 | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
|