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Brief Title: Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
Official Title: Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4
Study ID: NCT05243797
Brief Summary: This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Flinders Medical Centre, Adelaide, , Australia
Barwon Health, Geelong, , Australia
Alfred Hospital, Melbourne, , Australia
Calvary Mater Hospital, Newcastle, , Australia
Concord Hospital, Sydney, , Australia
St Vincent's hospital, Sydney, , Australia
Townsville Hospital, Townsville, , Australia
Clinic Ottakring, Vienna, , Austria
University Hospital Leuven, Leuven, , Belgium
AC Camargo Cancer Center, São Paulo, , Brazil
University Hospital, Brno, Brno, , Czechia
University Hospital Hradec Králové, Hradec Králové, , Czechia
University Hospital, Olomouc, Olomouc, , Czechia
University Hospital Ostrava, Ostrava, , Czechia
University Hospital Pilsen, Pilsen, , Czechia
General University Hospital, Prague, Praha, , Czechia
Rigshospitalet, Copenhagen, , Denmark
University Hospital of Würzburg, Würzburg, , Germany
Regional General Hospital Alexandra, Athens, , Greece
St Savvas Cancer Hospital, Athens, , Greece
A.O.U. di Bologna - Policlinico S. Orsola Malpighi, Bologna, , Italy
A.O.Spedali Civili di Brescia, Brescia, , Italy
Amsterdam Medical Center, Amsterdam, , Netherlands
Erasmus MC, Rotterdam, Rotterdam, , Netherlands
Oslo University Hospital, Oslo, , Norway
University Clinical Center of Serbia, Belgrade, , Serbia
Kantonsspital St. Gallen, Saint Gallen, , Switzerland
Ankara University, Ankara, , Turkey
St James's University Hospital, Leeds, , United Kingdom
Name: Niels van de Donk, Professor
Affiliation: Amsterdam UMC, Vrije Universiteit Amsterdam
Role: PRINCIPAL_INVESTIGATOR
Name: Elena Zamagni, Professor
Affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"
Role: PRINCIPAL_INVESTIGATOR