Page contents Back to list Full notification Final report General information GMO characterization European Commission administrative Information Return to search
Full notification Final report - General information Notification Number B/DE/22/PEI4979 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 25/07/2022 Title of the Project A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem CellTransplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible  Proposed period of release: 01/09/2022 to 01/09/2037 Name of the Institute(s) or Company(ies) European Myeloma Network (EMN)
Is the same GMO been notified elsewhere by the same notifier? No Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): B/ES/19/16; B/ES/19/25; B/ES/18/32; B/NL/19/002,; B/NL/19/011; B/NL/19/012,; B/NL/19/014; GMO characterization GMO is a: Other Identity of the GMO: The GMO, refered to as JNJ-68284528 consists of autologous T cells genetically modified to express a synthetic chimeric antigen receptor (CAR). The CAR recognises the cell surface marker B cell maturation antigen (BCMA) Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Human Genus: Homo Species: Homo Sapiens Subspecies: Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
Close
Select your language
English