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

July 17, 2017 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XM02 Filgrastim (Granix) and Plerixafor
  • 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.
Drug: Plerixafor
Other Names:
  • Mozobil, AMD3100
Drug: XM02 Filgrastim
Other Names:
  • Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix
Procedure: Apheresis
Procedure: Stem Cell Transplant
Other Names:
  • ASCT
Active Comparator: Filgrastim (Neupogen) and Plerixafor
  • 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.
Drug: Filgrastim
Other Names:
  • Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF
Drug: Plerixafor
Other Names:
  • Mozobil, AMD3100
Procedure: Apheresis
Procedure: Stem Cell Transplant
Other Names:
  • ASCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
Time Frame: Day 5
Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 20 days after last apheresis (Day 25-Day 28)
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.
Up to Day 30 post-infusion
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.
Up to Day 100
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
Up to Day 100
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)
Up to Day 8 (total collection)
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)
Up to Day 8 (total collection)
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
Day 5
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
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2014

Primary Completion (Actual)

June 10, 2016

Study Completion (Actual)

September 18, 2016

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201403068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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