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Completed

NCT Number: NCT03317899

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hematopoietic Cell Transplantation

Procedure

Undergo auto HSCT

Tbo-filgrastim

Drug

Given subcutaneously

Other names: Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Granix

laboratory biomarker analysis

Other

Correlative Studies

Primary outcomes

  1. Number of Days to Discharge

    Time frame: Up to 60 days

    Will compare days to discharge readiness between the two groups.

Secondary outcomes

  1. Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment

    Time frame: 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.

  2. Median Days Post Auto HSCT to Platelet Engraftment

    Time frame: 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.

  3. Percentage of Participants With Engraftment Syndrome

    Time frame: Up to 60 days

    Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test

  4. Median Number of Febrile Days During the Auto HSCT Inpatient Stay

    Time frame: Up to 60 days

    Will be summarized by treatment arm and compared using Wilcoxon rank sum tests

  5. Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay

    Time frame: Up to 60 days

    Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.

  6. Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay

    Time frame: Up to 60 days

    Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant

  7. Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay

    Time frame: Up to 60 days

    Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.

  8. Percentage of Participants Receiving Corticosteroids

    Time frame: Up to 60 days

    will be presented as percentage of number of subjects who had the treatment

  9. Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT

    Time frame: Up to 60 days

    will be presented as percentage of number of subjects who had the treatment

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Oct 23, 2017
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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