NCT03323541

Use of Zarzio® in Post-autologous Stem Cell Transplantation Procedure

Utilisation du ZArzio® en Post-Autogreffe de Cellules Souches périphériques Des Patients Atteints de Lymphome ou Myélome (in French)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma
• Non-hodgkin Lymphoma
• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Filgrastim Prefilled Syringe [Zarzio®]	Daily subcutaneous injection of Zarxio post ASCT, from day 5 until bone marrow recovery (neutrophils \>1 giga/l)

Timeline

• Start date: 2016-11-03
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2017-10-27
• Last updated: 2018-09-21

Regulatory

• FDA-regulated drug study