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

Completed · Phase 2

Conditions studied: Multiple Myeloma, Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT02098109

Run by

Washington University School of Medicine

People needed

100

Starts

2014-08-20

Expected to finish

2016-09-18

Last updated by the study team

2017-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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