NCT02098109已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Previous autologous stem cell collection
- •Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products
- •Pregnant or breastfeeding
研究组 & 干预措施
XM02 Filgrastim (Granix) and Plerixafor
Experimental
- 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.
干预措施: XM02 Filgrastim (Drug)
XM02 Filgrastim (Granix) and Plerixafor
Experimental
- 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.
干预措施: Apheresis (Procedure)
XM02 Filgrastim (Granix) and Plerixafor
Experimental
- 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.
干预措施: Plerixafor (Drug)
XM02 Filgrastim (Granix) and Plerixafor
Experimental
- 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.
干预措施: Stem Cell Transplant (Procedure)
Filgrastim (Neupogen) and Plerixafor
Active Comparator
- 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.
干预措施: Filgrastim (Drug)
Filgrastim (Neupogen) and Plerixafor
Active Comparator
- 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.
干预措施: Apheresis (Procedure)
Filgrastim (Neupogen) and Plerixafor
Active Comparator
- 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.
干预措施: Plerixafor (Drug)
Filgrastim (Neupogen) and Plerixafor
Active Comparator
- 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.
干预措施: Stem Cell Transplant (Procedure)
结局指标
主要结局
Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
时间窗: Day 5
次要结局
- 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)
- 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))
- Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms(Up to 20 days after last apheresis (Day 25-Day 28))
- Comparison of the Time to Neutrophil Engraftment Between the Two Arms(Up to Day 30 post-infusion)
- Comparison of the Time to Platelet Engraftment Between the Two Arms(Up to Day 100)
- Comparison of the Readmission Rate Between the Two Arms(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(Up to Day 8 (total collection))
- 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)
研究者
研究点 (1)
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