Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
74 participants
INTERVENTIONAL
2023-11-01
2025-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biosimilar pegfilgrastim
Day +5 of cell infusion: Biosimilar pegfilgrastim or Lapelga™ (one dose)
Lapelga
On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection
Biosimilar filgrastim
Day +5 of cell infusion: Biosimilar filgrastim or Grastofil® (one dose for 5 days)
Grastofil®
On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection for 5 days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Apobiologix.
UNKNOWN
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Shona Philip, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Central Contacts
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Other Identifiers
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1233770
Identifier Type: -
Identifier Source: org_study_id
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