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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Hodgkin's Lymphoma; Plasma Cell Myeloma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Hematopoietic Cell Transplantation; Drug: Tbo-filgrastim

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Other: Laboratory Biomarker Analysis; Correlative Studies; Procedure: Hematopoietic Cell Transplantation; Undergo auto HSCT; Drug: Tbo-filgrastim; Given subcutaneously; Other Names: Filgrastim XM02; Granix; Filgrastim Biosimilar Tbo-filgrastim
Experimental: Group II (auto HSCT); Patients undergo auto Hematopoietic Cell Transplantation (HSCT).	Other: Laboratory Biomarker Analysis; Correlative Studies; Procedure: Hematopoietic Cell Transplantation; Undergo auto HSCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days to discharge	Will compare days to discharge readiness between the two groups.	Up to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Median number of days on corticosteroids	Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.	Up to 60 days
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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Dolores Grosso, DNP, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital
• Sidney Kimmel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: 17D.404

Drug and device information, study documents

• 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