Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/26/2018 |
Start Date: | October 12, 2017 |
End Date: | June 2022 |
Contact: | Dolores Grosso, DNP |
Email: | dolores.gross@jefferson.edu |
Phone: | 215-955-8874 |
A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
This randomized 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.
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.
PRIMARY OBJECTIVES:
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 OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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.
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 OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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.
Inclusion Criteria:
- Undergoing autologous stem cell transplant for one of the following diagnoses:
- 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 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
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
Phone: 215-955-8874
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