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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317899
• Other study ID #: 17D.404
• Status: Completed
• Phase: Phase 2
• Start date: October 12, 2017
• Est. completion date: November 16, 2022

Study information

• Verified date: November 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 16, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Hodgkin's Lymphoma
• Plasma Cell Myeloma

Intervention

Procedure:
• Hematopoietic Cell Transplantation
Undergo auto HSCT

Drug:
• Tbo-filgrastim
Given subcutaneously

Other:
• Laboratory Biomarker Analysis
Correlative Studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days to discharge	Will compare days to discharge readiness between the two groups.	Up to 60 days
Secondary	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.	Up to 60 days
Secondary	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.	Up to 60 days
Secondary	Incidence of engraftment syndrome	Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test	Up to 60 days
Secondary	Median number of febrile days during the auto HSCT inpatient stay	Will be summarized by treatment arm and compared using Wilcoxon rank sum tests	Up to 60 days
Secondary	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.	Up to 60 days
Secondary	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	Up to 60 days
Secondary	Median number of antibiotic days during the auto HSCT inpatient stay	Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.	Up to 60 days
Secondary	Median number of days on corticosteroids	Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.	Up to 60 days
Secondary	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.	Up to 60 days

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital