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

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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.

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.

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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