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
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Aug 2014
Shorter than P25 for phase_2 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedStudy Start
First participant enrolled
August 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2016
CompletedResults Posted
Study results publicly available
July 18, 2017
CompletedJuly 18, 2017
July 1, 2017
1.8 years
March 20, 2014
June 8, 2017
July 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
Day 5
Secondary Outcomes (8)
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Up to 20 days after last apheresis (Day 25-Day 28)
Comparison of the Time to Neutrophil Engraftment Between the Two Arms
Up to Day 30 post-infusion
Comparison of the Time to Platelet Engraftment Between the Two Arms
Up to Day 100
Comparison of the Readmission Rate Between the Two Arms
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)
- +3 more secondary outcomes
Study Arms (2)
XM02 Filgrastim (Granix) and Plerixafor
EXPERIMENTAL* 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) and Plerixafor
ACTIVE COMPARATOR* 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous autologous stem cell collection
- Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
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.
PMID: 28797783DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Camille Abboud, M.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Camille Abboud, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
March 27, 2014
Study Start
August 20, 2014
Primary Completion
June 10, 2016
Study Completion
September 18, 2016
Last Updated
July 18, 2017
Results First Posted
July 18, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share