NCT02098109

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	XM02 Filgrastim
DRUG	Filgrastim
PROCEDURE	Apheresis
DRUG	Plerixafor
PROCEDURE	Stem Cell Transplant

Timeline

• Start date: 2014-08-20
• Primary completion: 2016-06-10
• Completion: 2016-09-18
• First posted: 2014-03-27
• Last updated: 2017-07-18
• Results posted: 2017-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study