Study identification

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)
First published:
22/03/2024
Institution Other ENCePP partner

Contact details

Massoud Toussi

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe B.V.
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)