Lapelga vs Gastrofil

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116734
• Other study ID #: 1233770
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Shona Philip, MD
• Phone: 519-685-8500
• Email: Shona.Philip[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Engagement, Patient
• Febrile Neutropenia
• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Neutropenia

Intervention

Drug:
• Grastofil®
On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection for 5 days
• Lapelga
On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Apobiologix.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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