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

Primary Purpose

Non-Hodgkin's Lymphoma, Plasma Cell Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hematopoietic Cell Transplantation
Tbo-filgrastim
Laboratory Biomarker Analysis
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (auto HSCT tbo-filgrastim)

Group II (auto HSCT)

Arm Description

Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.

Patients undergo auto Hematopoietic Cell Transplantation (HSCT).

Outcomes

Primary Outcome Measures

Number of days to discharge
Will compare days to discharge readiness between the two groups.

Secondary Outcome Measures

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.
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.
Incidence of engraftment syndrome
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
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
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
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
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Median number of days on corticosteroids
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
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.

Full Information

First Posted
October 18, 2017
Last Updated
November 16, 2022
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03317899
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
November 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Plasma Cell Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (auto HSCT tbo-filgrastim)
Arm Type
Experimental
Arm Description
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Arm Title
Group II (auto HSCT)
Arm Type
Experimental
Arm Description
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic Cell Transplantation
Intervention Description
Undergo auto HSCT
Intervention Type
Drug
Intervention Name(s)
Tbo-filgrastim
Other Intervention Name(s)
Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Granix
Intervention Description
Given subcutaneously
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative Studies
Primary Outcome Measure Information:
Title
Number of days to discharge
Description
Will compare days to discharge readiness between the two groups.
Time Frame
Up to 60 days
Secondary Outcome Measure Information:
Title
Median days post autologous hematopoietic cell transplantation (auto HSCT) to neutrophil engraftment
Description
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.
Time Frame
Up to 60 days
Title
Median days post auto HSCT to platelet engraftment
Description
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.
Time Frame
Up to 60 days
Title
Incidence of engraftment syndrome
Description
Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test
Time Frame
Up to 60 days
Title
Median number of febrile days during the auto HSCT inpatient stay
Description
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
Time Frame
Up to 60 days
Title
Median number of days of febrile neutropenia during the auto HSCT inpatient stay
Description
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time Frame
Up to 60 days
Title
Median number of documented infections treatment during the auto HSCT inpatient stay
Description
Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant
Time Frame
Up to 60 days
Title
Median number of antibiotic days during the auto HSCT inpatient stay
Description
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time Frame
Up to 60 days
Title
Median number of days on corticosteroids
Description
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time Frame
Up to 60 days
Title
Number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT
Description
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time Frame
Up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolores Grosso, DNP
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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