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

• Status: Completed
• Trial end date: 2016-09-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: JM 3100; Lenograstim; Plerixafor; Sargramostim

Criteria

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