Back to resultsNon-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
Primary Purpose
Multiple Myeloma, Lymphoma, Non-Hodgkin
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XM02 Filgrastim
Filgrastim
Apheresis
Plerixafor
Stem Cell Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
XM02 Filgrastim (Granix) and Plerixafor
Filgrastim (Neupogen) and Plerixafor
Arm 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.
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.
Outcomes
Primary Outcome Measures
Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
Secondary Outcome Measures
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
-Adverse events will be assessed using CTCAE version 4.0
Comparison of the Time to Neutrophil Engraftment Between the Two Arms
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.
Comparison of the Time to Platelet Engraftment Between the Two Arms
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.
Comparison of the Readmission Rate Between the Two Arms
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
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
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
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
Full Information
NCT ID
NCT02098109
First Posted
March 20, 2014
Last Updated
July 17, 2017
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02098109
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 20, 2014 (Actual)
Primary Completion Date
June 10, 2016 (Actual)
Study Completion Date
September 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Lymphoma, Non-Hodgkin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XM02 Filgrastim (Granix) and Plerixafor
Arm Type
Experimental
Arm 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.
Arm Title
Filgrastim (Neupogen) and Plerixafor
Arm Type
Active Comparator
Arm 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 Type
Drug
Intervention Name(s)
XM02 Filgrastim
Other Intervention Name(s)
Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF
Intervention Type
Procedure
Intervention Name(s)
Apheresis
Intervention Type
Drug
Intervention Name(s)
Plerixafor
Other Intervention Name(s)
Mozobil, AMD3100
Intervention Type
Procedure
Intervention Name(s)
Stem Cell Transplant
Other Intervention Name(s)
ASCT
Primary Outcome Measure Information:
Title
Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Description
-Adverse events will be assessed using CTCAE version 4.0
Time Frame
Up to 20 days after last apheresis (Day 25-Day 28)
Title
Comparison of the Time to Neutrophil Engraftment Between the Two Arms
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.
Time Frame
Up to Day 30 post-infusion
Title
Comparison of the Time to Platelet Engraftment Between the Two Arms
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.
Time Frame
Up to Day 100
Title
Comparison of the Readmission Rate Between the Two Arms
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
Time Frame
Up to Day 100
Title
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)
Title
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)
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille Abboud, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28797783
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.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
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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