Clinical trial NCT02098109: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lymphoma, Non-Hodgkin
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility 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

Primary outcomes:
measure: Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
timeFrame: Day 5
Secondary outcomes:
measure: Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
timeFrame: Up to 20 days after last apheresis (Day 25-Day 28)
measure: Comparison of the Time to Neutrophil Engraftment Between the Two Arms
timeFrame: Up to Day 30 post-infusion
measure: Comparison of the Time to Platelet Engraftment Between the Two Arms
timeFrame: Up to Day 100
measure: Comparison of the Readmission Rate Between the Two Arms
timeFrame: Up to Day 100
measure: Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
timeFrame: Up to Day 8 (total collection)
measure: Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
timeFrame: Up to Day 8 (total collection)
measure: 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
timeFrame: Day 5
measure: 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
timeFrame: Day 5
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Camille Abboud, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhamidipati PK, Fiala MA, Grossman BJ, DiPersio JF, Stockerl-Goldstein K, Gao F, Uy GL, Westervelt P, Schroeder MA, Cashen AF, Abboud CN, Vij R. Results of a Prospective Randomized, Open-Label, Noninferiority Study of Tbo-Filgrastim (Granix) versus Filgrastim (Neupogen) in Combination with Plerixafor for Autologous Stem Cell Mobilization in Patients with Multiple Myeloma and Non-Hodgkin Lymphoma. Biol Blood Marrow Transplant. 2017 Dec;23(12):2065-2069. doi: 10.1016/j.bbmt.2017.07.023. Epub 2017 Aug 7.