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/1000000046
• EU PAS number:
  EUPAS49370
• Study ID:
  1000000046
• 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
• Study status:
  Planned

Research institution and networks

Institutions

Johnson & Johnson

40 centres are involved in this study

Study timelines

Date when funding contract was signed

Planned: 03/06/2022

Actual: 03/06/2022

Study start date

Planned: 28/06/2024

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. (50%); Legend Biotech (50%)

Study protocol

Initial protocol

23May2024-REDACTED_Protocol-FD-68284528MMY4009-588202_946738 (1).pdf

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