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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 )

Tracking Information
First Submitted Date  ICMJE October 18, 2017
First Posted Date  ICMJE October 23, 2017
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE October 12, 2017
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
Number of days to discharge [ Time Frame: Up to 60 days ]
Will compare days to discharge readiness between the two groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03317899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
  • 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.
  • 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.
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Official Title  ICMJE A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
Intervention  ICMJE
  • Procedure: Hematopoietic Cell Transplantation
    Undergo auto HSCT
  • Drug: Tbo-filgrastim
    Given subcutaneously
    Other Names:
    • Filgrastim Biosimilar Tbo-filgrastim
    • Filgrastim XM02
    • Granix
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Hematopoietic Cell Transplantation
    • Drug: Tbo-filgrastim
  • Experimental: Group II (auto HSCT)
    Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
    Intervention: Procedure: Hematopoietic Cell Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2017)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dolores Grosso, DNP 215-955-8874 dolores.gross@jefferson.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03317899
Other Study ID Numbers  ICMJE 17D.404
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dolores Grosso, DNP Sidney Kimmel Cancer Center at Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP