Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
NCT ID: NCT03317899
Last Updated: 2025-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2017-10-12
2022-11-16
Brief Summary
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Detailed Description
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I. To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support.
SECONDARY OBJECTIVE:
I. To compare days to absolute neutrophil count (ANC) \> 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support.
EXPLORATORY OBJECTIVE:
I. To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I (auto HSCT tbo-filgrastim)
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation
Undergo auto HSCT
Tbo-filgrastim
Given subcutaneously
Laboratory Biomarker Analysis
Correlative Studies
Group II (auto HSCT)
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation
Undergo auto HSCT
Laboratory Biomarker Analysis
Correlative Studies
Interventions
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Hematopoietic Cell Transplantation
Undergo auto HSCT
Tbo-filgrastim
Given subcutaneously
Laboratory Biomarker Analysis
Correlative Studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Multiple myeloma
* Non-Hodgkin lymphoma
* Karnofsky performance status of \>= 70%
* Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
* Left ventricular ejection fraction (LVEF) of ≥ 40%
* Adjusted Carbon monoxide diffusing capability (DLCO) \> 45% of predicted corrected for hemoglobin
* Serum bilirubin \< 1.8
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 X upper limit of normal
* Serum creatinine =\< 2.0 mg/dl and/or creatinine clearance of \> 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning)
* Willingness to use contraception if childbearing potential
* Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
* Life expectancy of \> 12 months (exclusive of the disease for which the auto HSCT is being performed)
* Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
* Collection of an adequate number of CD34+ stem cells, i.e. \>= 4-6 x 10\^6/kg from apheresis
Exclusion Criteria
* Uncontrolled bacterial infection
* Active central nervous system (CNS) disease
* Pregnancy or lactation
* Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
18 Years
ALL
No
Sponsors
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Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Dolores Grosso, DNP
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Sidney Kimmel Cancer Center
Thomas Jefferson University Hospital
Other Identifiers
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JT 10928
Identifier Type: OTHER
Identifier Source: secondary_id
17D.404
Identifier Type: -
Identifier Source: org_study_id