Multiple MyelomaZAPANCT03323541
Use of Zarzio® in Post-autologous Stem Cell Transplantation Procedure
An observational study of Multiple Myeloma and Non-hodgkin Lymphoma, run by University Hospital, Brest.
Trial summary
There are limited data concerning the use of biosimilars of filgrastim in autologous stem cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based on haemograms, transfusion needs and complications) of two biosimilars (Zarzio and Ratiograstim®) compared to those of Neupogen® for our… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Non-hodgkin Lymphoma, Hodgkin Lymphoma
- What is being tested?
- Filgrastim Prefilled Syringe [Zarzio®]
- Type of treatment
- Injection or infusion
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2016to 31 Dec 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated by ASCT in the case of DLBCL or Hodgkin disease or multiple myeloma
Who may be able to join
- patients with DLBCL or multiple myeloma
- patients who underwent ASCT in our hospital
- patients treated by Zarzio® in post-ASCT phase to accelerate the bone marrow recovery
Who cannot join
- patients who underwent ASCT but for other diseases
- patients who underwent ASCT for the required diseases but treated with an other biosimilar of Filgrastim
- patients who did not sign the informed consent
About this study
Official title: Utilisation du ZArzio® en Post-Autogreffe de Cellules Souches périphériques Des Patients Atteints de Lymphome ou Myélome (in French)
There are limited data concerning the use of biosimilars of filgrastim in autologous stem cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based on haemograms, transfusion needs and complications) of two biosimilars (Zarzio and Ratiograstim®) compared to those of Neupogen® for our patients who underwent ASCT.
Read the detailed description
Since 2008, Investigator collected data of all patients who underwent ASCT to treat lymphoma or myeloma.
All the patients signed an institutional informed consent form before the harvest of peripheric stem cells (PROMISE program). Patients received Neupogen® (Amgen-SA) between April 2008 and February 2010, and the next group of patients was treated with Ratiograstim® (Ratiopharm GmbH) until May 2012. The last group of patients received Zarzio® (Sandoz GmbH) until November 2014.
Investigator studied the impact of the Zarzio® use on biological parameters of the bone marrow recovery, transfusion needs and infectious complications. These parameters were then compared to those of the previous patients which were treated with the two other drugs.
The patients were recruited in the University Hospital of Brest. They were consecutive patients, treated by ASCT for their high risk lymphoma and myeloma but without selection.
- Conditions
- Multiple Myeloma, Non-hodgkin Lymphoma, Hodgkin Lymphoma
- Being tested
- Filgrastim Prefilled Syringe [Zarzio®]
- Keywords
- biosimilars, filgrastim, Stem cell transplantation, lymphoma, multiple myeloma
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filgrastim Prefilled Syringe [Zarzio®]Drug
Also called Filgrastim prefilled syringe [Neupogen®]
Daily subcutaneous injection of Zarxio post ASCT, from day 5 until bone marrow recovery (neutrophils >1 giga/l)
| Study group | Role | What they receive |
|---|---|---|
| Group of patients treated with Zarxio | All consecutive patients, treated for lymphoma or myeloma, which underwent autologous stem cell transplantation in the University Hospital of Brest. All these patients were treated with biosimilars of Filgrastim: Zarzio®. Receives: Drug: Filgrastim Prefilled Syringe [Zarzio®] |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to bone marrow recovery
timing in days from the day of ASCT until the day when neutrophils >1 giga/l
Measured: daily evaluation, around 8 days normally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start3 Nov 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IANOTTO Jean-Christophe, MD, PhD, Principal investigator, Hématologie Clinique-Institut de Cancéro-Hématologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323541
- Sponsor's protocol ID
- ZAPA
- Acronym
- ZAPA
- Status last verified
- Sep 2018
- First submitted
- 24 Oct 2017
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicol C, Henry C, Couturier MA, Delepine P, Tripogney C, Buors C, Guillerm G, Berthou C, Tempescul A, Ianotto JC. Biosimilars of filgrastim in autologous stem cell transplantation: certain differences for myeloma patients only. Leuk Lymphoma. 2017 Sep;58(9):1-3. doi: 10.1080/10428194.2017.1285025. Epub 2017 Feb 7. No abstract available.
PubMed 28278727
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilisation du ZArzio® en Post-Autogreffe de Cellules Souches périphériques Des Patients Atteints de Lymphome ou Myélome (in French)
- ClinicalTrials.gov ID
- NCT03323541
- Acronym / sponsor ID
- ZAPA / ZAPA
- Conditions
- Multiple Myeloma, Non-hodgkin Lymphoma, Hodgkin Lymphoma
- Keywords
- biosimilars, filgrastim, Stem cell transplantation, lymphoma, multiple myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 27 Oct 2017 (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.
There are limited data concerning the use of biosimilars of filgrastim in autologous stem cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based on haemograms, transfusion needs and complications) of two biosimilars (Zarzio and Ratiograstim®) compared to those of Neupogen® for our patients who underwent ASCT.
Detailed description
Since 2008, Investigator collected data of all patients who underwent ASCT to treat lymphoma or myeloma.
All the patients signed an institutional informed consent form before the harvest of peripheric stem cells (PROMISE program). Patients received Neupogen® (Amgen-SA) between April 2008 and February 2010, and the next group of patients was treated with Ratiograstim® (Ratiopharm GmbH) until May 2012. The last group of patients received Zarzio® (Sandoz GmbH) until November 2014.
Investigator studied the impact of the Zarzio® use on biological parameters of the bone marrow recovery, transfusion needs and infectious complications. These parameters were then compared to those of the previous patients which were treated with the two other drugs.
The patients were recruited in the University Hospital of Brest. They were consecutive patients, treated by ASCT for their high risk lymphoma and myeloma but without selection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of patients treated with Zarxio | – | Drug: Filgrastim Prefilled Syringe [Zarzio®]All consecutive patients, treated for lymphoma or myeloma, which underwent autologous stem cell transplantation in the University Hospital of Brest. All these patients were treated with biosimilars of Filgrastim: Zarzio®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated by ASCT in the case of DLBCL or Hodgkin disease or multiple myeloma
Key inclusion criteria (3 listed)
- patients with DLBCL or multiple myeloma
- patients who underwent ASCT in our hospital
- patients treated by Zarzio® in post-ASCT phase to accelerate the bone marrow recovery
Key exclusion criteria (3 listed)
- patients who underwent ASCT but for other diseases
- patients who underwent ASCT for the required diseases but treated with an other biosimilar of Filgrastim
- patients who did not sign the informed consent
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 |
|---|---|---|
| Filgrastim Prefilled Syringe [Zarzio®]Also: Filgrastim prefilled syringe [Neupogen®]Daily subcutaneous injection of Zarxio post ASCT, from day 5 until bone marrow recovery (neutrophils >1 giga/l) | Drug | Group of patients treated with Zarxio |
Primary outcome
time to bone marrow recovery
Time frame: daily evaluation, around 8 days normally
timing in days from the day of ASCT until the day when neutrophils >1 giga/l
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Results publication: PubMed 28278727Nicol C, Henry C, Couturier MA, Delepine P, Tripogney C, Buors C, Guillerm G, Berthou C, Tempescul A, Ianotto JC. Biosimilars of filgrastim in autologous stem cell transplantation: certain differences for myeloma patients only. Leuk Lymphoma. 2017 Sep;58(9):1-3. doi: 10.1080/10428194.2017.1285025. Epub 2017 Feb 7. No abstract available.
- Individual participant dataSharing planned: No
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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.
IANOTTO Jean-Christophe, MD, PhD principal investigator
Hématologie Clinique-Institut de Cancéro-Hématologie
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Non-hodgkin Lymphoma, run by University Hospital, Brest.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Sep 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to bone marrow recovery (time frame: daily evaluation, around 8 days normally). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323541, which also lists 1 linked publication.
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 21 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.