NCT03317899 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-12-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Days to Discharge

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outcome · POSTED

Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment

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outcome · POSTED

Median Days Post Auto HSCT to Platelet Engraftment

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outcome · POSTED

Percentage of Participants With Engraftment Syndrome

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outcome · POSTED

Median Number of Febrile Days During the Auto HSCT Inpatient Stay

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outcome · POSTED

Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay

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outcome · POSTED

Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay

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outcome · POSTED

Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay

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outcome · POSTED

Percentage of Participants Receiving Corticosteroids

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outcome · POSTED

Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
intervention Names
Procedure: Hematopoietic Cell Transplantation
Drug: Tbo-filgrastim
Other: Laboratory Biomarker Analysis
label
Group I (auto HSCT tbo-filgrastim)
type
EXPERIMENTAL
description
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
intervention Names
Procedure: Hematopoietic Cell Transplantation
Other: Laboratory Biomarker Analysis
label
Group II (auto HSCT)
type
EXPERIMENTAL

interventions

arm Group Labels
Group I (auto HSCT tbo-filgrastim)
Group II (auto HSCT)
description
Undergo auto HSCT
name
Hematopoietic Cell Transplantation
type
PROCEDURE
arm Group Labels
Group I (auto HSCT tbo-filgrastim)
description
Given subcutaneously
name
Tbo-filgrastim
other Names
Filgrastim Biosimilar Tbo-filgrastim
Filgrastim XM02
Granix
type
DRUG
arm Group Labels
Group I (auto HSCT tbo-filgrastim)
Group II (auto HSCT)
description
Correlative Studies
name
Laboratory Biomarker Analysis
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 77
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Will compare days to discharge readiness between the two groups.
measure
Number of Days to Discharge
time Frame
Up to 60 days

secondary Outcomes

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.
measure
Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment
time Frame
Up to 60 days
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.
measure
Median Days Post Auto HSCT to Platelet Engraftment
time Frame
Up to 60 days
description
Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test
measure
Percentage of Participants With Engraftment Syndrome
time Frame
Up to 60 days
description
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
measure
Median Number of Febrile Days During the Auto HSCT Inpatient Stay
time Frame
Up to 60 days
description
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
measure
Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay
time Frame
Up to 60 days
description
Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant
measure
Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay
time Frame
Up to 60 days
description
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
measure
Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay
time Frame
Up to 60 days
description
will be presented as percentage of number of subjects who had the treatment
measure
Percentage of Participants Receiving Corticosteroids
time Frame
Up to 60 days
description
will be presented as percentage of number of subjects who had the treatment
measure
Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT
time Frame
Up to 60 days

Full 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.

Source references