Status: Ongoing First registered on: 25/03/2020
Last updated on: 07/10/2020
1. Study identification
EU PAS Register NumberEUPAS34255
Official titleNon-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 title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: Germany, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research groupPharmacoepidemiology and Drug Safety
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Toussi
First name Massoud
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/12/201909/12/2019
Start date of data collection30/06/202006/08/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstellas Pharma Europe B.V.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Registration Department
First name Clinical Trial
Address line 1Astellas, One Astellas Way
Address line 2 
Address line 3 
CityNorthbrook, IL 
Postcode60062 
CountryUnited States
Phone number (incl. country code)18008887704 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltrialregistration@astellas.com
Public Enquiries
Title Mr 
Last name Registration Department 
First name Clinical Trial 
Address line 1Astellas, One Astellas Way 
Address line 2 
Address line 3 
CityNorthbrook, IL 
Postcode60062 
CountryUnited States 
Phone number (incl. country code)18008887704 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltrialregistration@astellas.com 
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