Overview

This trial is active, not recruiting.

Conditions multiple myeloma, lymphoma, non-hodgkin
Treatments xm02 filgrastim, filgrastim, apheresis, plerixafor
Phase phase 2
Sponsor Washington University School of Medicine
Start date August 2014
End date December 2016
Trial size 100 participants
Trial identifier NCT02098109, 201403068

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
XM02 Filgrastim 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)
xm02 filgrastim Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix
apheresis
plerixafor Mozobil, AMD3100
(Active Comparator)
Filgrastim 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)
filgrastim Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF
apheresis
plerixafor Mozobil, AMD3100

Primary Outcomes

Measure
Comparison of the CD34+cells/kg yield between the two arms
time frame: Up to Day 8

Secondary Outcomes

Measure
Comparison of adverse events (safety) between the two arms
time frame: Up to 20 days after last aphereis (Day 25-Day 28)
Comparison of the rate of neutrophil engraftment between the two arms
time frame: Up to Day 30
Comparison of the percentage of patients who collect ≥ 2.0x10^6 CD34+cells/kg and ≥ 5.0x10^6 CD34+cells/kg, respectively, following PBSC mobilization between the two arms
time frame: Up to Day 8
Comparison of the percentage of patients who collect ≥ 2.0x10^6 CD34+cells/kg and ≥ 5.0x10^6 CD34+cells/kg, respectively, in one apheresis procedure following PBSC mobilization between the two arms
time frame: Up to Day 8
Comparison of the rate of platelet engraftment between the two arms
time frame: Up to Day 100
Comparison of the readmission rate between the two arms
time frame: Up to Day 100

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Camille Abboud, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.
Location data was received from the National Cancer Institute and was last updated in June 2016.