Clinical trial · Interventional
Lapelga vs Gastrofil
Open-label, Randomized Comparative Study to Assess Biosimilar Pegfilgrastim Versus Biosimilar Filgrastim in Patients With Multiple Myeloma and Lymphoma Post Autologous Hematopoietic Stem Cell Transplantation
- 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 is examining one-time injection of biosimilar pegfilgrastim compared with multiple injection biosimilar filgrastim post autologous hematopoietic stem cell transplantation. Study aims to compare biosimilar pegfilgrastim - LaPelga and biosimilar filgrastim -Gastrofil to see if they are similar in efficacy in terms of neutrophil engraftment, limited adverse effects, and more convenience to our patients, with potential cost savings.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Engagement, Patient | — | UNRESOLVED | — |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Grastofil® | Drug | Filgrastim | ALIAS |
| Lapelga | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Biosimilar pegfilgrastim
- description
- Day +5 of cell infusion: Biosimilar pegfilgrastim or Lapelga™ (one dose)
- interventionNames
- Drug: Lapelga
- type
- ACTIVE_COMPARATOR
- label
- Biosimilar filgrastim
- description
- Day +5 of cell infusion: Biosimilar filgrastim or Grastofil® (one dose for 5 days)
- interventionNames
- Drug: Grastofil®
Primary outcomes (1)
- measure
- Engraftment
- timeFrame
- 11 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be able and willing to give written informed consent prior to any study related procedures * Patients with a diagnosis of multiple myeloma or lymphoma who are eligible for autologous stem cell transplant * All adult patients aged 18 to 75 years * All patients admitted to LHSC for autologous peripheral blood stem cell transplant receiving peripheral blood stem cell infusions at LHSC and post-transplant care at either LHSC or WMH. * Of the patients who are admitted for autologous stem cell transplant, the patients that meet the risk adapted approach for GSCF will be included in the study. The risk adapted criteria are aged 60 or greater, infusion of stem cells with a CD34 count less than or equal 3 x 10\^6/kg, prior episodes of febrile neutropenia, or at the providers clinical discretion * Conditioning chemotherapy as per usual clinical practice Exclusion Criteria:Patients satisfying the above inclusion criteria but with the following contraindications (prior to randomization) will be excluded from the study: * Any clinical contraindications to filgrastim, e.g. hypersensitivity to G-CSF or E. coli-derived proteins * Pain requiring opioids with use of filgrastim during mobilization of autologous stem cells. * Unable or not willing to provide written consent
References
Publications (0)
Data not yet available