Clinical trial NCT03323541: Use of Zarzio® in Post-autologous Stem Cell Transplantation Procedure
Official title: Utilisation du ZArzio® en Post-Autogreffe de Cellules Souches périphériques Des Patients Atteints de Lymphome ou Myélome (in French)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Non-hodgkin Lymphoma
Hodgkin Lymphoma
Keywords: biosimilars
filgrastim
Stem cell transplantation
lymphoma
multiple myeloma
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated by ASCT in the case of DLBCL or Hodgkin disease or multiple myeloma

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: time to bone marrow recovery
timeFrame: daily evaluation, around 8 days normally
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hématologie Clinique-Institut de Cancéro-Hématologie
name: IANOTTO Jean-Christophe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.