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

Multiple Myeloma Clinical Trial

— ZAPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323541
• Other study ID #: ZAPA
• Status: Completed
• Start date: November 3, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 patients who underwent ASCT.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-hodgkin Lymphoma

Intervention

Drug:
• Filgrastim Prefilled Syringe [Zarzio®]
Daily subcutaneous injection of Zarxio post ASCT, from day 5 until bone marrow recovery (neutrophils >1 giga/l)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

References & Publications (1)

Nicol C, Henry C, Couturier MA, Delépine 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to bone marrow recovery	timing in days from the day of ASCT until the day when neutrophils >1 giga/l	daily evaluation, around 8 days normally