Non-Interventional Post-Authorisation Safety Study (NI-PASS) as an effectiveness check of an additional Risk Minimisation Measure (aRMM) (Direct Healthcare Professional Communication [DHPC]) for Bendamustine

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41682
• EU PAS number:
  EUPAS34255
• Study ID:
  41682
• Official title and acronym:
  Non-Interventional Post-Authorisation Safety Study (NI-PASS) as an effectiveness check of an additional Risk Minimisation Measure (aRMM) (Direct Healthcare Professional Communication [DHPC]) for Bendamustine
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  This study will be carried out to evaluate the effectiveness of an additional risk minimization measure (aRMM) (a Direct Healthcare Professional Communication DHPC letter) for bendamustine. The purpose of this study is to evaluate all-cause mortality and serious and fatal infections occurring in pre- and post-DHPC dissemination periods for new users of bendamustine during these periods, as well as for new users of other alkylating drugs similar to bendamustine (i.e. cyclophosphamide for indolent non-Hodgkin’s lymphoma (iNHL), chlorambucil for chronic lymphocytic leukemia (CLL), melphalan for multiple myeloma (MM)) in populations in four European countries. Additionally, the other purpose of this study is to quantify and characterise approved and off-label use of bendamustine and other alkylating drugs similar to bendamustine (alternative treatments) in new users in pre- and post-DHPC dissemination periods in populations from four European countries.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Solutions, IQVIA

Netherlands

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned: 09/12/2019

Actual: 09/12/2019

Study start date

Planned: 30/06/2020

Actual: 26/06/2020

Date of interim report, if expected

Actual: 26/05/2021

Date of final study report

Planned: 31/03/2023

Actual: 19/04/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe B.V.

Study protocol

Initial protocol

6231-ma-3264-clrp-02-disc01-en-final-02

Updated protocol

6231-MA-3264_Bendamustine NI-PASS_Protocol_v7.0-Disclosure-Redacted (1)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)