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
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
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.
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
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