Status:
UNKNOWN
Lapelga vs Gastrofil
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Apobiologix.
Conditions:
Multiple Myeloma
Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 com...
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 Ho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06116734
Start Date
November 1 2023
End Date
November 1 2025
Last Update
November 3 2023
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