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

Phase 2CompletedNCT02098109

Washington University School of Medicine100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Multiple Myeloma Lymphoma, Non-Hodgkin

Interventions

XM02 FilgrastimDRUG

FilgrastimDRUG

ApheresisPROCEDURE

PlerixaforDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms

Time frame: Day 5

Secondary Outcomes

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

Time frame: Up to 20 days after last apheresis (Day 25-Day 28)

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.

Time frame: Up to Day 30 post-infusion

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.

Time frame: Up to Day 100

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

Time frame: Up to Day 100

Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms

Time frame: Up to Day 8 (total collection)

Data from ClinicalTrials.gov

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