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
Status: Recruiting
Location: See all (202) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
• Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
• Must not be intolerant to the starting dose of lenalidomide.
• Must not have received any maintenance therapy.
• Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
• Have clinical laboratory values within prespecified range.
Locations
United States
Arizona
The University of Arizona Cancer Center
NOT_YET_RECRUITING
Phoenix
California
University of California-Davis Cancer Center
RECRUITING
Sacramento
University of California, San Diego (UCSD) Medical Center
RECRUITING
San Diego
Colorado
University of Colorado Hospital
NOT_YET_RECRUITING
Aurora
Colorado Blood Cancer Institute
NOT_YET_RECRUITING
Denver
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Delaware
Christiana Care
NOT_YET_RECRUITING
Newark
Florida
Blood & Marrow Transplant Center, Florida Hospital Medical Group
NOT_YET_RECRUITING
Orlando
Moffitt at Memorial Healthcare System
NOT_YET_RECRUITING
Tampa
Illinois
University of Illinois Medical Center at Chicago
NOT_YET_RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Maryland
Greenebaum Cancer Center UM of MD
RECRUITING
Baltimore
John Hopkins
RECRUITING
Baltimore
North Carolina
Levine Cancer Institute
NOT_YET_RECRUITING
Charlotte
Duke University
NOT_YET_RECRUITING
Durham
East Carolina University
NOT_YET_RECRUITING
Greenville
New York
Mount Sinai Medical Center - 2
RECRUITING
New York
Montefiore Medical Cente
NOT_YET_RECRUITING
The Bronx
Ohio
University of Cincinnati
NOT_YET_RECRUITING
Cincinnati
Seidman Cancer Center-University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Ohio State Medical Center, James Cancer Center
RECRUITING
Columbus
Pennsylvania
Lehigh Valley Health Network
NOT_YET_RECRUITING
Allentown
Penn State Hershey Medical Center
NOT_YET_RECRUITING
Hershey
Abramson Cancer Center University of Pennsylvania Medical Center
RECRUITING
Philadelphia
Fox Chase Cancer Center
NOT_YET_RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina (MUSC)
NOT_YET_RECRUITING
Charleston
Gibbs Cancer Center
NOT_YET_RECRUITING
Spartanburg
Tennessee
Vanderbilt University
NOT_YET_RECRUITING
Nashville
Texas
Baylor College of Medicine Center for Cell and Gene Therapy
NOT_YET_RECRUITING
Houston
Utah
LDS Hospital/ Intermountain Healthcare
NOT_YET_RECRUITING
Salt Lake City
Virginia
Virginia Oncology Associates
NOT_YET_RECRUITING
Norfolk
Wisconsin
St Vincent HSHS (Green Bay Oncology)
RECRUITING
Green Bay
University of Wisconsin Hospital and Clinics
RECRUITING
Madison
Froedtert Memorial Lutheran Hospital
NOT_YET_RECRUITING
Milwaukee
Other Locations
Argentina
Hospital Italiano
RECRUITING
Buenos Aires
Hospital Privado
RECRUITING
Córdoba
Sanatorio Britanico Rosario
RECRUITING
Rosario
Australia
Flinders Medical Centre
RECRUITING
Adelaide
Sunshine Coast Health
RECRUITING
Birtinya
Townsville University Hospital
RECRUITING
Douglas
Barwon Health University Hospital Geelong Andrew Love Cancer Centre
RECRUITING
Geelong
Alfred Hospital
RECRUITING
Melbourne
Austin Health
RECRUITING
Melbourne
Calvary Mater Hospital
RECRUITING
Newcastle
Sunshine Coast Health
RECRUITING
Sunshine Coast
Concord Repatriation General Hospital
RECRUITING
Sydney
Royal North Shore Hospital
RECRUITING
Sydney
Austria
Landeskrankenhaus, Feldkirch
RECRUITING
Feldkirch
Medizinische Universitaet Innsbruck
RECRUITING
Innsbruck
University Hospital Krems/Donau
RECRUITING
Krems
Kepler Universitätsklinikum Med Campus III
RECRUITING
Linz
Ordensklinikum Linz GmbH
RECRUITING
Linz
Uniklinikum Salzburg
RECRUITING
Salzburg
Clinic Ottakring
RECRUITING
Vienna
LKH Hochsteiermark
RECRUITING
Vienna
Belgium
Jessa Ziekenhuis
RECRUITING
Hasselt
Department of Hematology, CH Jolimont
NOT_YET_RECRUITING
La Louvière
Algemeen Ziekenhuis Delta
RECRUITING
Leuven
University Hospital Leuven
RECRUITING
Leuven
Centre hospitalier universitaire de Liege
RECRUITING
Liège
Brazil
Hospital Mãe de Deus - Centro Integrado de Oncologia
NOT_YET_RECRUITING
Porto Alegre
Hospital Santa Rita
NOT_YET_RECRUITING
Porto Alegre
Instituto Americas de Ensino,Pesquisa e Inovação
NOT_YET_RECRUITING
Rio De Janeiro
IDOR- Instituto D'or de pesquisa. Av. São Rafael
NOT_YET_RECRUITING
Salvador
A Real e Benemérita Associação Portuguesa de Beneficência
NOT_YET_RECRUITING
São Paulo
Clínica Medica São Germano,Grupo Oncoclínicas Pesquisa Clínica
NOT_YET_RECRUITING
São Paulo
Departamento de Oncologia Clínica AC Camargo Cancer Center
NOT_YET_RECRUITING
São Paulo
Grupo Oncoclínicas Pesquisa Clínica
NOT_YET_RECRUITING
São Paulo
Hcor, Associacao Siria
NOT_YET_RECRUITING
São Paulo
Hemocentro UNICAMP, Universidade Estadual de Campinas
NOT_YET_RECRUITING
São Paulo
Hospital das Clínicas da Universidade de São Paulo
NOT_YET_RECRUITING
São Paulo
Hospital Paulistano, Centro de Pesquisa Clinica R. Martiniano de Carvalho
NOT_YET_RECRUITING
São Paulo
Onco Star
NOT_YET_RECRUITING
São Paulo
Universidade Federal de São Paulo - Hospital São Paulo
NOT_YET_RECRUITING
São Paulo
Canada
Cross Cancer Institute
NOT_YET_RECRUITING
Edmonton
QEII Health Sciences Centre
RECRUITING
Halifax
The Ottawa General Hospital
RECRUITING
Ottawa
Saskatoon Cancer Center
RECRUITING
Saskatoon
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
RECRUITING
Sherbrooke
Princess Margaret Cancer Centre
RECRUITING
Toronto
BC Cancer
NOT_YET_RECRUITING
Vancouver
China
Beijing Chaoyang Hospital
RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
North China University of Science and Technology Affiliated Hospital.Hematology Department
NOT_YET_RECRUITING
Hebei
Henan Cancer Hospital
RECRUITING
Henan
Shandong Qilu Hospital
RECRUITING
Shandong
Shanghai Fourth People's Hospital
NOT_YET_RECRUITING
Shanghai
Shenyang City, Liaoning Province, Hematology department
NOT_YET_RECRUITING
Shenyang
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Tongji Hospital, Tongji Medical College of Hust
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital, Zhejiang University College of Medicine
NOT_YET_RECRUITING
Zhejiang
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
Lillebaelt Hospital
RECRUITING
Vejle
France
Centre Hospitalier Universitaire De Bordeaux
RECRUITING
Bordeaux
Department of Hematology, CHU Lille
RECRUITING
Lille
Institut Paoli Calmettes
RECRUITING
Marseille
Centre Hospitalier Universitaire De Montpellier
RECRUITING
Montpellier
Centre Hospitalier Universitaire De Nantes
RECRUITING
Nantes
Hopital Saint Louis
RECRUITING
Paris
Hôpital Saint-Antoine
RECRUITING
Paris
Centre Hospitalier Universitaire De Poitiers
RECRUITING
Poitiers
Centre Hospitalier Universitaire De Toulouse
RECRUITING
Toulouse
Germany
University Medical Center Hamburg-Eppendorf
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg AöR
RECRUITING
Heidelberg
Universitaetsklinikum Jena KöR
RECRUITING
Jena
Universitaetsklinikum Schleswig-Holstein AöR
ACTIVE_NOT_RECRUITING
Lübeck
Klinikum rechts der Isar der TU Muenchen AöR
RECRUITING
München
Klinikum Nuernberg
RECRUITING
Nuremberg
Universitaetsklinikum Tuebingen AöR
RECRUITING
Tübingen
University Hospital of Würzburg
RECRUITING
Würzburg
Greece
University General Hospital Of Alexandroupoli
RECRUITING
Alexandroupoli
Evaggelismos Hospital
RECRUITING
Athens
Regional General Hospital Alexandra
RECRUITING
Athens
Theageneio Cancer Hospital
RECRUITING
Thessaloniki
Ireland
Cork University Hospital
RECRUITING
Cork
Beaumont Hospital
RECRUITING
Dublin
St James's Hospital
RECRUITING
Dublin
St Vincent's University Hospital
RECRUITING
Dublin
University Hospital Galway
RECRUITING
Galway
University Hospital Limerick
RECRUITING
Limerick
Israel
The Barzilai Medical Center
RECRUITING
Beersheba
Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Beilinson Hospital
RECRUITING
Petah Tikva
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel-Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda Sanitaria Locale Al Di Alessandria
RECRUITING
Alessandria
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
RECRUITING
Ancona
AOU G. Baccelli
RECRUITING
Bari
Policlinico di Bari
RECRUITING
Bari
A.O. Papa Giovanni XXIII
RECRUITING
Bergamo
A.O.U. di Bologna - Policlinico S. Orsola Malpighi
RECRUITING
Bologna
A.O.Spedali Civili di Brescia
RECRUITING
Brescia
Ospedale Oncologico 'A. Businco'
NOT_YET_RECRUITING
Cagliari
Azienda Ospedaliera-Universitaria Di Cosenza
RECRUITING
Cosenza
Careggi University Hospital
RECRUITING
Florence
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
IRCCS Ospedale Maggiore Policlinico
RECRUITING
Milan
Azienda Ospedaliero Universitaria Di Modena
RECRUITING
Modena
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
RECRUITING
Napoli
UOC Oncoematologia, Ospedale Policlinico Federico II
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliero-Universitaria Maggiore Della Carita
RECRUITING
Novara
UOC Ematologia - Azienda Ospedale - Università Padova Ospedale Giustinianeo
NOT_YET_RECRUITING
Padua
Department of Hematology and Bone Marrow Transplant Centre, Azienda Ospedaliero - Universitaria di Parma
NOT_YET_RECRUITING
Parma
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Azienda Sanitaria Locale Di Pescara
RECRUITING
Pescara
Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
Azienda USL IRCCS Di Reggio Emilia
RECRUITING
Reggio
Ospedale Infermi di Rimini
RECRUITING
Rimini
Ematologia, Azienda Policlinico Umberto I
RECRUITING
Roma
Casa Sollievo Della Sofferenza
RECRUITING
San Giovanni Rotondo
A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
RECRUITING
Torino
A.O.U. Ospedali Riuniti di Trieste
RECRUITING
Trieste
Azienda Sanitaria Universitaria Friuli Centrale
RECRUITING
Udine
Netherlands
Noordwest Ziekenhuisgroep Stichting
RECRUITING
Alkmaar
Amsterdam University Medical Center
RECRUITING
Amsterdam
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
Maxima Medisch Centrum
RECRUITING
Eindhoven
University Medical Center Groningen
RECRUITING
Groningen
Dijklander Ziekenhuis
RECRUITING
Hoorn
St. Antonius Ziekenhuis
RECRUITING
Nieuwegein
Erasmus University Medical Center Rotterdam
RECRUITING
Rotterdam
Maasstad Ziekenhuis
RECRUITING
Rotterdam
Norway
Oslo University Hospital
NOT_YET_RECRUITING
Oslo
St. Olavs hospital HF
RECRUITING
Trondheim
Poland
Department of Hematology and Transplantology University Clinical Center
ACTIVE_NOT_RECRUITING
Gdansk
SPZOZ MSWiA w Poznaniu im. Prof. Ludwika Bierkowskiego, Poznań
RECRUITING
Poznan
Uniwersytecki Szpital Kliniczny
NOT_YET_RECRUITING
Wroclaw
Portugal
CCAB Centro Clinico Academico Braga Associacao
NOT_YET_RECRUITING
Braga
Champalimaud Clinical Centre
NOT_YET_RECRUITING
Lisbon
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
NOT_YET_RECRUITING
Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
NOT_YET_RECRUITING
Porto
Sao Joao University Hospital Center
NOT_YET_RECRUITING
Porto
Unidade Local De Saude De Gaia/Espinho E.P.E.
NOT_YET_RECRUITING
Porto
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
RECRUITING
Vila Real
Republic of Korea
Chonnam National University Hwasun Hospital
RECRUITING
Gwangju
Department of Oncology, Asan Medical Center
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital, Internal Medicine
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
St. Mary's Hospital
RECRUITING
Seoul
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
Clinical Centre of Kragujevac
RECRUITING
Kragujevac
Clinical Centre of Nis
RECRUITING
Niš
Clinical Centre of Vojvodina
RECRUITING
Novi Sad
Switzerland
University Hospital Basel
RECRUITING
Basel
Inselspital
RECRUITING
Bern
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Turkey
Ankara Liv Hospital
RECRUITING
Ankara
Ankara University Hospital
RECRUITING
Ankara
Florence Nightingale Hospital
RECRUITING
Istanbul
Memorial Sisli Hospital, Dept of Hematology
NOT_YET_RECRUITING
Istanbul
Ege University Medical faculty Hospital Internal Medicine Department Adult Hematology Unit
RECRUITING
Izmir
Izmir Economy University, Medical Point Hospital
NOT_YET_RECRUITING
Izmir
Erciyes University Hospital
RECRUITING
Kayseri
United Kingdom
Hammersmith Hospital - Imperial College NHS Healthcare Trust
RECRUITING
London
University College London (UCL)
RECRUITING
London
The Royal Marsden Hospital
RECRUITING
Sutton
Contact Information
Primary
Sabrin Tahri
sabrin.tahri@emn.org
+31 10 268 70 65
Backup
Sarah Lonergan
sarah.lonergan@emn.org
+31 10 268 70 65
Time Frame
Start Date: 2022-09-08
Estimated Completion Date: 2032-04
Participants
Target number of participants: 1594
Treatments
Experimental: Arm A: Teclistamab-Lenalidomide (Tec-Len)
Teclistamab will be administered via a subcutaneous injection (SC)
Active_comparator: Arm B Lenalidomide Alone (Len)
Lenalidomide orally.
Experimental: Arm C Teclistamab-Alone (Tec)
Teclistamab will be administered via a subcutaneous injection (SC)
Related Therapeutic Areas
Sponsors
Leads: Stichting European Myeloma Network
Collaborators: Janssen Pharmaceutica