Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
- Conditions
- Non-Hodgkin's LymphomaPlasma Cell Myeloma
- Interventions
- Procedure: Hematopoietic Cell TransplantationOther: Laboratory Biomarker Analysis
- Registration Number
- NCT03317899
- Brief Summary
This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.
- Detailed Description
PRIMARY OBJECTIVE:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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Undergoing autologous stem cell transplant for one of the following diagnoses:
- Multiple myeloma
- Non-Hodgkin lymphoma
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Karnofsky performance status of >= 70%
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Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
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Left ventricular ejection fraction (LVEF) of ≥ 40%
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Adjusted Carbon monoxide diffusing capability (DLCO) > 45% of predicted corrected for hemoglobin
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Serum bilirubin < 1.8
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Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 X upper limit of normal
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Serum creatinine =< 2.0 mg/dl and/or creatinine clearance of > 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning)
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Willingness to use contraception if childbearing potential
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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
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Life expectancy of > 12 months (exclusive of the disease for which the auto HSCT is being performed)
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Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
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Collection of an adequate number of CD34+ stem cells, i.e. >= 4-6 x 10^6/kg from apheresis
- Uncontrolled human immunodeficiency virus (HIV)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I (auto HSCT tbo-filgrastim) Hematopoietic Cell Transplantation Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Group I (auto HSCT tbo-filgrastim) Laboratory Biomarker Analysis Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Group II (auto HSCT) Hematopoietic Cell Transplantation Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Group II (auto HSCT) Laboratory Biomarker Analysis Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Group I (auto HSCT tbo-filgrastim) Tbo-filgrastim Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
- Primary Outcome Measures
Name Time Method Number of days to discharge Up to 60 days Will compare days to discharge readiness between the two groups.
- Secondary Outcome Measures
Name Time Method Median days post autologous hematopoietic cell transplantation (auto HSCT) to neutrophil engraftment Up to 60 days Will be defined as absolute neutrophil count \> 500 x 10\^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count \> 500 x 10\^9/L.
Median days post auto HSCT to platelet engraftment Up to 60 days Will be defined as date platelet greater than or equal to 20 x 10\^9 /L without a platelet transfusion within the last 7 days.
Median number of febrile days during the auto HSCT inpatient stay Up to 60 days Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
Median number of days of febrile neutropenia during the auto HSCT inpatient stay Up to 60 days Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Median number of documented infections treatment during the auto HSCT inpatient stay Up to 60 days Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant
Median number of antibiotic days during the auto HSCT inpatient stay Up to 60 days Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Median number of days on corticosteroids Up to 60 days Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT Up to 60 days Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Incidence of engraftment syndrome Up to 60 days Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test
Trial Locations
- Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States