Clinical trial NCT03317899: Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Official title: A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Plasma Cell Myeloma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of days to discharge
timeFrame: Up to 60 days
Secondary outcomes:
measure: Median days post autologous hematopoietic cell transplantation (auto HSCT) to neutrophil engraftment
timeFrame: Up to 60 days
measure: Median days post auto HSCT to platelet engraftment
timeFrame: Up to 60 days
measure: Incidence of engraftment syndrome
timeFrame: Up to 60 days
measure: Median number of febrile days during the auto HSCT inpatient stay
timeFrame: Up to 60 days
measure: Median number of days of febrile neutropenia during the auto HSCT inpatient stay
timeFrame: Up to 60 days
measure: Median number of documented infections treatment during the auto HSCT inpatient stay
timeFrame: Up to 60 days
measure: Median number of antibiotic days during the auto HSCT inpatient stay
timeFrame: Up to 60 days
measure: Median number of days on corticosteroids
timeFrame: Up to 60 days
measure: Number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Dolores Grosso, DNP
role: PRINCIPAL_INVESTIGATOR
References: