Clinical trial · Interventional
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant
NCT05338047CI-TRIAL-00064332completedPhase 2ClinicalTrials.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 is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma Multiple | Multiple Myeloma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Generic pegfilgrastim
- description
- One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant
- interventionNames
- Drug: Pegfilgrastim
- type
- ACTIVE_COMPARATOR
- label
- Brand name pegfilgrastim
- description
- One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant
- interventionNames
- Drug: Pegfilgrastim
Primary outcomes (1)
- measure
- Time to neutrophil recovery
- timeFrame
- 15 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing autologous peripheral blood stem cell transplantation * Patients with multiple myeloma or lymphoma * Adults (\>18 years) * Both genders * Eastern Cooperative Oncology Group (ECOG) \<=2 Exclusion Criteria: * Alanine Aminotransferase or bilirubin values \>2.5 times the superior normal limit * Creatinin \>2.2mg/dL * Fever \>37.6°C * Active infection * Hepatitis B, C or HIV infection * Congestive heart failure (ejection fraction \<40%)
References
Publications (2)
- RESULTJagasia MH, Greer JP, Morgan DS, Mineishi S, Kassim AA, Ruffner KL, Chen H, Schuening FG. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Transplant. 2005 Jun;35(12):1165-9. doi: 10.1038/sj.bmt.1704994. PMID 15880129
- RESULTSheth V, Gore A, Jain R, Ghanekar A, Saikia T. Pegfilgrastim: More Cost Effective and Equally Efficacious Option as Compared to Filgrastim in Autologous Stem Cell Transplant. Indian J Hematol Blood Transfus. 2019 Jan;35(1):66-71. doi: 10.1007/s12288-018-0966-5. Epub 2018 May 17. PMID 30828150