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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098109
• Other study ID #: 201403068
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2014
• Last updated: July 17, 2017
• Start date: August 20, 2014
• Est. completion date: September 18, 2016

Study information

• Verified date: July 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 18, 2016
• Est. primary completion date: June 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• XM02 Filgrastim

• Filgrastim

Procedure:
• Apheresis

Drug:
• Plerixafor

Procedure:
• Stem Cell Transplant

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms		Day 5
Secondary	Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms	-Adverse events will be assessed using CTCAE version 4.0	Up to 20 days after last apheresis (Day 25-Day 28)
Secondary	Comparison of the Time to Neutrophil Engraftment Between the Two Arms	Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count = 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.	Up to Day 30 post-infusion
Secondary	Comparison of the Time to Platelet Engraftment Between the Two Arms	Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count = 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.	Up to Day 100
Secondary	Comparison of the Readmission Rate Between the Two Arms	Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse	Up to Day 100
Secondary	Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms		Up to Day 8 (total collection)
Secondary	Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms		Up to Day 8 (total collection)
Secondary	Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms		Day 5
Secondary	Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms		Day 5

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine