A Post-authorization Safety Study to Evaluate the Safety of Multiple Myeloma Patients Treated with Ciltacabtagene Autoleucel

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50027
• EU PAS number:
  EUPAS49218
• Study ID:
  50027
• Official title and acronym:
  A Post-authorization Safety Study to Evaluate the Safety of Multiple Myeloma Patients Treated with Ciltacabtagene Autoleucel
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Brazil

  Germany

  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned: 03/06/2022

Actual: 03/06/2022

Study start date

Planned: 30/09/2022

Actual: 25/04/2022

Date of final study report

Planned: 30/06/2042

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Research & Development, LLC Legend Biotech USA, Inc

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/005095/0000

Other study registration identification numbers and links

68284528MMY4004