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

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ClinicalTrials.gov Identifier: NCT03317899
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Multiple Myeloma Procedure: Hematopoietic Cell Transplantation Drug: Tbo-filgrastim Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Group I (auto HSCT tbo-filgrastim)
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Procedure: Hematopoietic Cell Transplantation
Undergo auto HSCT

Drug: Tbo-filgrastim
Given subcutaneously
Other Names:
  • Filgrastim Biosimilar Tbo-filgrastim
  • Filgrastim XM02
  • Granix

Experimental: Group II (auto HSCT)
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Procedure: Hematopoietic Cell Transplantation
Undergo auto HSCT




Primary Outcome Measures :
  1. Number of days to discharge [ Time Frame: Up to 60 days ]
    Will compare days to discharge readiness between the two groups.


Secondary Outcome Measures :
  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. Incidence of 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. Median number of days on corticosteroids [ Time Frame: Up to 60 days ]
    Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.

  9. Number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT [ Time Frame: Up to 60 days ]
    Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317899


Contacts
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Contact: Dolores Grosso, DNP 215-955-8874 dolores.gross@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Dolores Grosso, DNP    215-955-8874    dolores.grosso@jefferson.edu   
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Dolores Grosso, DNP Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03317899     History of Changes
Other Study ID Numbers: 17D.404
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs