Lapelga vs Gastrofil

Trial Title: Lapelga vs Gastrofil

NCT ID: NCT06116734

Condition: Multiple Myeloma
Lymphoma
Engagement, Patient
Febrile Neutropenia

Conditions: Official terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neutropenia
Febrile Neutropenia

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Grastofil®
Description: On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection for 5 days
Arm group label: Biosimilar filgrastim

Other name: biosimilar filgrastim

Intervention type: Drug
Intervention name: Lapelga
Description: On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection
Arm group label: Biosimilar pegfilgrastim

Other name: biosimilar pegfilgrastim

Summary: 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.

Detailed description: This will be a prospective open randomized controlled study. The study will be conducted in the inpatient setting at the London Health Sciences Centre (LHSC) in London, ON, and Windsor Metropolitan Hospital (WMH) in Windsor, ON. The objective of the study is to assess if biosimilar Peg-filgrastim similar is non-inferior to biosimilar filgrastim (LaPelga versus gastrofil) in terms of neutrophil engraftment in autologous transplant patients with lymphoma and multiple myeloma. Current clinical practice uses a risk-adapted approach where we use originator filgrastim - Neupogen starting on day 5 for patients who 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 provider's clinical discretion. For the purposes of the trial, patients will be randomized to LaPelga versus gastrofil arm directly and will initiate assigned treatment at day+5 of autologous transplant. Both LHSC and WMH have qualified investigators (hematologists or other qualified clinicians. The study will start only after receipt of regulatory and ethics approval. Screening investigations on patients will be done only after the signing of written informed consent.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: November 1, 2023

Completion date: November 1, 2025

Lead sponsor:
Agency: Lawson Health Research Institute
Agency class: Other

Collaborator:
Agency: Apobiologix.
Agency class: Other

Source: Lawson Health Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06116734