Clinical trial · Interventional
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
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
NCT02098109CI-TRIAL-00028663completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apheresis | Procedure | — | UNRESOLVED |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Plerixafor | Drug | Plerixafor | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
| XM02 Filgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- XM02 Filgrastim (Granix) and Plerixafor
- 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.
- interventionNames
- Drug: XM02 Filgrastim
- Procedure: Apheresis
- Drug: Plerixafor
- Procedure: Stem Cell Transplant
- type
- ACTIVE_COMPARATOR
- label
- Filgrastim (Neupogen) and Plerixafor
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBhamidipati 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. PMID 28797783