Study identification

PURI

https://redirect.ema.europa.eu/resource/48309

EU PAS number

EUPAS45152

Study ID

48309

Official title and acronym

Non-interventional Post-authorization Safety Study (PASS) of Patients Treated with Idecabtagene Vicleucel (ide-cel, BB2121) for Multiple Myeloma (MM) in the Postmarketing Setting (BB2121-MM-006)

DARWIN EU® study

No

Study countries

Austria
Belgium
Croatia
Czechia
Denmark
Finland
France
Germany
Greece
Italy
Netherlands
Norway
Poland
Portugal
Spain
Sweden
Switzerland
United Kingdom
United States

Study description

The purpose of this post-authorization safety study (PASS) is to characterize the safety profile of ide-cel in the postmarketing setting. This study will include patients from existing independent registries, such as, but not limited to, the European Society for Blood and Marrow Transplantation (EBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The BB2121-MM-006 study will be part of the overall ide-cel Risk Management Plan (RMP) including any required regional Pharmacovigilance Plan (PVP) outside the European Union (EU).

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Center for International Blood and Marrow Transplant Research (CIBMTR), European Society for Blood and Marrow Transplantation (EBMT)

Contact details

Amanda Anderson

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb
Study protocol
Initial protocol

BB2121-MM-006-prot-v1-redacted

English (446.6 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)

Regulatory procedure number

EMEA/H/C/004662