NCT02098109 · REGISTRY CONDITION SEARCH

Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in 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: 2017-07-18

This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.

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

Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms

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outcome · POSTED

Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms

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outcome · POSTED

Comparison of the Time to Neutrophil Engraftment Between the Two Arms

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outcome · POSTED

Comparison of the Time to Platelet Engraftment Between the Two Arms

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outcome · POSTED

Comparison of the Readmission Rate Between the Two Arms

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outcome · POSTED

Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms

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outcome · POSTED

Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms

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outcome · POSTED

Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms

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outcome · POSTED

Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms

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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: * At least 18 years of age * Diagnosis of multiple myeloma or non-Hodgkin lymphoma * Eligible for autologous transplantation * Adequate bone marrow function as defined as: * White Blood Cell Count ≥ 3.0x109/L * Absolute Neutrophil Count ≥ 1.5x109/L * Platelet Count ≥ 100x109/L * Able to understand and willing to sign an IRB-approved informed consent document * Surgically or biologically sterile or willing to practice acceptable birth control, as follows: * Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day 1 of study treatment. Women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence * Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence Exclusion Criteria: * Previous autologous stem cell collection * Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products * Pregnant or breastfeeding
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
* XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) * Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) * Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met) * Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize \> 2.0 x 10\^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.
intervention Names
Drug: XM02 Filgrastim
Procedure: Apheresis
Drug: Plerixafor
Procedure: Stem Cell Transplant
label
XM02 Filgrastim (Granix) and Plerixafor
type
EXPERIMENTAL
description
* Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) * Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) * Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met) * Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize \> 2.0 x 10\^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.
intervention Names
Drug: Filgrastim
Procedure: Apheresis
Drug: Plerixafor
Procedure: Stem Cell Transplant
label
Filgrastim (Neupogen) and Plerixafor
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
XM02 Filgrastim (Granix) and Plerixafor
name
XM02 Filgrastim
other Names
Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix
type
DRUG
arm Group Labels
Filgrastim (Neupogen) and Plerixafor
name
Filgrastim
other Names
Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF
type
DRUG
arm Group Labels
Filgrastim (Neupogen) and Plerixafor
XM02 Filgrastim (Granix) and Plerixafor
name
Apheresis
type
PROCEDURE
arm Group Labels
Filgrastim (Neupogen) and Plerixafor
XM02 Filgrastim (Granix) and Plerixafor
name
Plerixafor
other Names
Mozobil, AMD3100
type
DRUG
arm Group Labels
Filgrastim (Neupogen) and Plerixafor
XM02 Filgrastim (Granix) and Plerixafor
name
Stem Cell Transplant
other Names
ASCT
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 100
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
time Frame
Day 5

secondary Outcomes

description
-Adverse events will be assessed using CTCAE version 4.0
measure
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
time Frame
Up to 20 days after last apheresis (Day 25-Day 28)
description
Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.
measure
Comparison of the Time to Neutrophil Engraftment Between the Two Arms
time Frame
Up to Day 30 post-infusion
description
Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.
measure
Comparison of the Time to Platelet Engraftment Between the Two Arms
time Frame
Up to Day 100
description
Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse
measure
Comparison of the Readmission Rate Between the Two Arms
time Frame
Up to Day 100
measure
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
time Frame
Up to Day 8 (total collection)
measure
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
time Frame
Up to Day 8 (total collection)
measure
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
time Frame
Day 5
measure
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
time Frame
Day 5

Full study description

brief Summary: This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.
detailed Description: This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor. The FDA has determined that Granix is biosimilar to Neupogen, which means that they are similar in terms of quality, safety, and efficacy; however, Granix has not been tested in the context of stem cell mobilization to see how its effectiveness compares to that of Neupogen

Source references

references

citation
Bhamidipati PK, Fiala MA, Grossman BJ, DiPersio JF, Stockerl-Goldstein K, Gao F, Uy GL, Westervelt P, Schroeder MA, Cashen AF, Abboud CN, Vij R. Results of a Prospective Randomized, Open-Label, Noninferiority Study of Tbo-Filgrastim (Granix) versus Filgrastim (Neupogen) in Combination with Plerixafor for Autologous Stem Cell Mobilization in Patients with Multiple Myeloma and Non-Hodgkin Lymphoma. Biol Blood Marrow Transplant. 2017 Dec;23(12):2065-2069. doi: 10.1016/j.bbmt.2017.07.023. Epub 2017 Aug 7.
pmid
28797783
type
DERIVED