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Completed

NCT Number: NCT02098109

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XM02 Filgrastim

Drug

Other names: Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix

Filgrastim

Drug

Other names: Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF

Apheresis

Procedure

plerixafor

Drug

Other names: Mozobil, AMD3100

Stem Cell Transplant

Procedure

Other names: ASCT

Primary outcomes

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

    Time frame: Day 5

Secondary outcomes

  1. 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)

    -Adverse events will be assessed using CTCAE version 4.0

  2. Comparison of the Time to Neutrophil Engraftment Between the Two Arms

    Time frame: Up to Day 30 post-infusion

    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.

  3. Comparison of the Time to Platelet Engraftment Between the Two Arms

    Time frame: Up to Day 100

    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.

  4. Comparison of the Readmission Rate Between the Two Arms

    Time frame: Up to Day 100

    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

  5. 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)

  6. 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)

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

A Randomized, Open Label, Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) When Administered in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 27, 2014
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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