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

Arm | Intervention/treatment |
---|---|
Experimental: XM02 Filgrastim (Granix) and Plerixafor
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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
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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 |
- Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms [ Time Frame: Day 5 ]
- 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
- 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.
- 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.
- 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
- 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) ]
- 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) ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years of age
- Diagnosis of multiple myeloma or non-Hodgkin lymphoma
- Eligible for autologous transplantation
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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
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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

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
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Camille Abboud, M.D. | Washington University School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |