Multiple MyelomaPhase 3NCT06116734
Lapelga vs Gastrofil
A Phase 3 study testing Grastofil® and Lapelga in people with Multiple Myeloma and Lymphoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
This study is examining one-time injection of biosimilar pegfilgrastim compared with multiple injection biosimilar filgrastim post autologous hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Lymphoma, Engagement, Patient
- What is being tested?
- Grastofil® and Lapelga
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma, Lymphoma, Engagement, Patient, Febrile Neutropenia
- Being tested
- Grastofil®, Lapelga
- Medical subject headings
- Multiple Myeloma, Lymphoma, Patient Participation, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grastofil®Drug
Also called biosimilar filgrastim
On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection for 5 days
LapelgaDrug
Also called biosimilar pegfilgrastim
On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Biosimilar pegfilgrastim | Experimental | Day +5 of cell infusion: Biosimilar pegfilgrastim or Lapelga™ (one dose) Receives: Drug: Lapelga |
| Biosimilar filgrastim | Active comparator | Day +5 of cell infusion: Biosimilar filgrastim or Grastofil® (one dose for 5 days) Receives: Drug: Grastofil® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 11 days
Secondary outcomes (1)
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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Apobiologix.
- Responsible party
- Sponsor
- Investigators
- Shona Philip, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116734
- Sponsor's protocol ID
- 1233770
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06116734
- Acronym / sponsor ID
- 1233770
- Conditions
- Multiple Myeloma, Lymphoma, Engagement, Patient, Febrile Neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Apobiologix.
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biosimilar pegfilgrastim | Experimental | Drug: LapelgaDay +5 of cell infusion: Biosimilar pegfilgrastim or Lapelga™ (one dose) |
| Biosimilar filgrastim | Active comparator | Drug: Grastofil®Day +5 of cell infusion: Biosimilar filgrastim or Grastofil® (one dose for 5 days) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grastofil®Also: biosimilar filgrastimOn day 5 after the hemopoietic stem cell transplant, one subcutaneous injection for 5 days | Drug | Biosimilar filgrastim |
| LapelgaAlso: biosimilar pegfilgrastimOn day 5 after the hemopoietic stem cell transplant, one subcutaneous injection | Drug | Biosimilar pegfilgrastim |
Primary outcome
Engraftment
Time frame: 11 days
•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)
1 secondary outcome
AE
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shona Philip, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grastofil® and Lapelga in people with Multiple Myeloma and Lymphoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shona Philip, MD (519-685-8500 ext. 56072, Shona.Philip@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment (time frame: 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.