Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)

Conditions
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Non-Hodgkin's Lymphoma, Plasma Cell Myeloma

Intervention / Treatment
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* Procedure: Hematopoietic Cell Transplantation
* Drug: Tbo-filgrastim
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (auto HSCT tbo-filgrastim)<br>Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. | Procedure: Hematopoietic Cell Transplantation<br>* Undergo auto HSCT<br>Drug: Tbo-filgrastim<br>* Given subcutaneously<br>* Other names: Granix;Other: Laboratory Biomarker Analysis<br>* Correlative Studies<br>|
| Experimental: Group II (auto HSCT)<br>Patients undergo auto Hematopoietic Cell Transplantation (HSCT). | Procedure: Hematopoietic Cell Transplantation<br>* Undergo auto HSCT<br>Other: Laboratory Biomarker Analysis<br>* Correlative Studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days to discharge | Will compare days to discharge readiness between the two groups. | Up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median days post autologous hematopoietic cell transplantation (auto HSCT) to neutrophil engraftment | 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. | Up to 60 days | 
| Median days post auto HSCT to platelet engraftment | 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. | Up to 60 days | 
| Incidence of engraftment syndrome | Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test | Up to 60 days | 
| Median number of febrile days during the auto HSCT inpatient stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests | Up to 60 days | 
| Median number of days of febrile neutropenia during the auto HSCT inpatient stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. | Up to 60 days | 
| Median number of documented infections treatment during the auto HSCT inpatient stay | Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant | Up to 60 days | 
| Median number of antibiotic days during the auto HSCT inpatient stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. | Up to 60 days | 
| Median number of days on corticosteroids | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. | Up to 60 days | 
| Number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. | Up to 60 days |