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

The Washington University

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Lymphoma, Non-Hodgkin

Treatments: Procedure: Stem Cell Transplant; Drug: Filgrastim; Drug: Plerixafor; Drug: XM02 Filgrastim; Procedure: Apheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT02098109

201403068

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

XM02 Filgrastim (Granix) and Plerixafor

Experimental group

Description:

* XM02 Filgrastim (Granix) 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) * Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize \> 2.0 x 10\^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.

Treatment:

Procedure: Apheresis

Drug: XM02 Filgrastim

Drug: Plerixafor

Procedure: Stem Cell Transplant

Filgrastim (Neupogen) and Plerixafor

Active Comparator group

Description:

* Filgrastim (Neupogen) 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) * Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize \> 2.0 x 10\^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.

Treatment:

Procedure: Apheresis

Drug: Plerixafor

Procedure: Stem Cell Transplant

Drug: Filgrastim