Phase 2
Completed N=100
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 · Lymphoma, Non-Hodgkin
Source: ClinicalTrials.gov NCT02098109 ↗
Enrolled (actual)
100
Serious AEs
5.1%
Results posted
Jul 2017
Primary outcomePrimary: Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms — 11.6; 10.0 cells/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms |
11.6; 10.0 | — |
| SECONDARY Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms |
19; 22; 18; 20; 13; 18 | — |
| SECONDARY Comparison of the Time to Neutrophil Engraftment Between the Two Arms |
11; 11.5 | — |
| SECONDARY Comparison of the Time to Platelet Engraftment Between the Two Arms |
18; 17.5 | — |
| SECONDARY Comparison of the Readmission Rate Between the Two Arms |
11; 9 | — |
| SECONDARY Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms |
100; 100 | — |
| SECONDARY Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms |
96; 96 | — |
| 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 |
98; 90 | — |
| 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 |
83; 76 | — |
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
Data sourced from ClinicalTrials.gov (NCT02098109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.