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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

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ClinicalTrials.gov Identifier: NCT02098109
Recruitment Status : Completed
First Posted : March 27, 2014
Results First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Lymphoma, Non-Hodgkin Drug: XM02 Filgrastim Drug: Filgrastim Procedure: Apheresis Drug: Plerixafor Procedure: Stem Cell Transplant Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 20, 2014
Actual Primary Completion Date : June 10, 2016
Actual Study Completion Date : September 18, 2016

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Arms and Interventions
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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: XM02 Filgrastim
Other Name: Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix

Procedure: Apheresis
Drug: Plerixafor
Other Name: Mozobil, AMD3100

Procedure: Stem Cell Transplant
Other Name: 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 Name: Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF

Procedure: Apheresis
Drug: Plerixafor
Other Name: Mozobil, AMD3100

Procedure: Stem Cell Transplant
Other Name: ASCT


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms [ Time Frame: Day 5 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098109


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Camille Abboud, M.D. Washington University School of Medicine
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02098109    
Other Study ID Numbers: 201403068
First Posted: March 27, 2014    Key Record Dates
Results First Posted: July 18, 2017
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Plerixafor octahydrochloride
Lenograstim
Sargramostim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents