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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Multiple Myeloma, Lymphoma, Non-Hodgkin

Intervention / Treatment
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* Drug: XM02 Filgrastim
* Drug: Filgrastim
* Procedure: Apheresis
* Drug: Plerixafor
* Procedure: Stem Cell Transplant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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