Lapelga vs Gastrofil

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymphoma, Multiple Myeloma, Engagement, Patient, Febrile Neutropenia

Intervention / Treatment
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* Drug: Grastofil®
* Drug: Lapelga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biosimilar pegfilgrastim<br>Day +5 of cell infusion: Biosimilar pegfilgrastim or Lapelga™ (one dose) | Drug: Lapelga<br>* On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection<br>* Other names: biosimilar pegfilgrastim;|
| Active Comparator: Biosimilar filgrastim<br>Day +5 of cell infusion: Biosimilar filgrastim or Grastofil® (one dose for 5 days) | Drug: Grastofil®<br>* On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection for 5 days<br>* Other names: biosimilar filgrastim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment | •Compare duration of neutropenia both in terms of absolute neutrophil count (ANC) <0.5 · 109 /l and of days to reach an ANC >0.5 · 109t between LaPelga versus gastrofil initiated at day 5 in patients with multiple myeloma or lymphoma post autologous transplant who meet the risk adapted criteria (age greater or equal to 60; prior episode of neutropenia and CD34 count of less than or equal to 3 X 10^6/kg cells infused) | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE | Clinically significant infections (CTCAE v 5, Infections, grade 2 or higher) Grade and duration of mucositis (CTCAE v 5, mucositis oral and diarrhea, any grade) | 30 days |