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)

June 3, 2026 updated by: European Myeloma Network B.V.

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

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.

Study Overview

Status

Recruiting

Conditions

Multiple Myeloma

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1594

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sabrin Tahri
Phone Number: +31 10 268 70 65
Email: Sabrin.Tahri@emn.org

Study Contact Backup

Name: Christine Witty
Phone Number: +31 10 268 70 65
Email: Christine.Witty@emn.org

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Recruiting
    - Hospital Italiano
    - Contact:
      
      Fantl
  - Córdoba, Argentina
    - Recruiting
    - Hospital Privado
    - Contact:
      
      Caeiro
  - Rosario, Argentina
    - Recruiting
    - Sanatorio Britanico Rosario
    - Contact:
      
      Funes
Australia
- - Adelaide, Australia
    - Recruiting
    - Flinders Medical Centre
    - Contact:
      
      Turner
  - Birtinya, Australia
    - Recruiting
    - Sunshine Coast Health
    - Contact:
      
      Wallington - Gates
  - Douglas, Australia
    - Recruiting
    - Townsville University Hospital
    - Contact:
      
      Lai
  - Geelong, Australia
    - Recruiting
    - Barwon Health University Hospital Geelong Andrew Love Cancer Centre
    - Contact:
      
      Campbell
  - Melbourne, Australia
    - Recruiting
    - Alfred Hospital
    - Contact:
      
      Spencer
    - Principal Investigator:
      
      Spencer
  - Melbourne, Australia
    - Recruiting
    - Austin Health
    - Contact:
      
      Hocking
  - Newcastle, Australia
    - Recruiting
    - Calvary Mater Hospital
    - Contact:
      
      Janowski
  - Sydney, Australia
    - Recruiting
    - Royal North Shore Hospital
    - Contact:
      
      Kerridge
  - Sydney, Australia
    - Recruiting
    - Concord Repatriation General Hospital
    - Contact:
      
      Wong Doo
Austria
- - Feldkirch, Austria
    - Recruiting
    - Landeskrankenhaus, Feldkirch
    - Contact:
      
      Hartmann
  - Innsbruck, Austria
    - Recruiting
    - Medizinische Universitaet Innsbruck
    - Contact:
      
      Willenbacher
  - Krems, Austria
    - Recruiting
    - University Hospital Krems/Donau
    - Contact:
      
      Podar
  - Linz, Austria
    - Recruiting
    - Ordensklinikum Linz GmbH
    - Contact:
      
      Strassl
  - Linz, Austria
    - Recruiting
    - Kepler Universitätsklinikum Med Campus III
    - Contact:
      
      Schmitt
  - Salzburg, Austria
    - Recruiting
    - Uniklinikum Salzburg
    - Contact:
      
      Melchardt
  - Vienna, Austria
    - Recruiting
    - Clinic Ottakring
    - Contact:
      
      Schreder
  - Vienna, Austria
    - Recruiting
    - LKH Hochsteiermark
    - Contact:
      
      Thamer
Belgium
- - Hasselt, Belgium
    - Recruiting
    - Jessa Ziekenhuis
    - Contact:
      
      Theunissen
  - La Louvière, Belgium
    - Recruiting
    - Department of Hematology, CH Jolimont
    - Contact:
      
      Kentos
  - Leuven, Belgium
    - Recruiting
    - University Hospital Leuven
    - Contact:
      
      Delforge
  - Liège, Belgium
    - Recruiting
    - Centre Hospitalier Universitaire de Liège
    - Contact:
      
      Caers
  - Roeselare, Belgium
    - Recruiting
    - Algemeen Ziekenhuis Delta
    - Contact:
      
      Deleu
Brazil
- - Porto Alegre, Brazil
    - Recruiting
    - Hospital Mãe de Deus - Centro Integrado de Oncologia
    - Contact:
      
      Capra
  - Porto Alegre, Brazil
    - Recruiting
    - Hospital Santa Rita
    - Contact:
      
      Vanelli Costa
  - Rio de Janeiro, Brazil
    - Recruiting
    - Instituto Americas de Ensino,Pesquisa e Inovação
    - Contact:
      
      Maiolino
  - Salvador, Brazil
    - Recruiting
    - IDOR- Instituto D'or de pesquisa. Av. São Rafael
    - Contact:
      
      Queiroz Crusoe
  - São Paulo, Brazil
    - Recruiting
    - Hospital das Clínicas da Universidade de São Paulo
    - Contact:
      
      Giancarlo Fatobene
  - São Paulo, Brazil
    - Recruiting
    - Universidade Federal de São Paulo - Hospital São Paulo
    - Contact:
      
      Braga
  - São Paulo, Brazil
    - Recruiting
    - Departamento de Oncologia Clínica AC Camargo Cancer Center
    - Contact:
      
      Schmidt Filho
  - São Paulo, Brazil
    - Recruiting
    - Hemocentro UNICAMP, Universidade Estadual de Campinas
    - Contact:
      
      Vieira Pericole
  - São Paulo, Brazil
    - Recruiting
    - Onco Star
    - Contact:
      
      Costa Neto
  - São Paulo, Brazil
    - Recruiting
    - A Real e Benemérita Associação Portuguesa de Beneficência
    - Contact:
      
      Leão Cordeiro de Farias
  - São Paulo, Brazil
    - Recruiting
    - Clínica Medica São Germano,Grupo Oncoclínicas Pesquisa Clínica
    - Contact:
      
      Tietsche de Moraes Hungria
  - São Paulo, Brazil
    - Withdrawn
    - Grupo Oncoclínicas Pesquisa Clínica
  - São Paulo, Brazil
    - Recruiting
    - Hcor, Associacao Siria
    - Contact:
      
      Lemos - Moura
  - São Paulo, Brazil
    - Withdrawn
    - Hospital Paulistano, Centro de Pesquisa Clinica R. Martiniano de Carvalho
Canada
- - Edmonton, Canada
    - Recruiting
    - Cross Cancer Institute
    - Contact:
      
      Sandhu
  - Halifax, Canada
    - Recruiting
    - QEII Health Sciences Centre
    - Contact:
      
      de la Torre
  - Ottawa, Canada
    - Recruiting
    - The Ottawa General Hospital
    - Contact:
      
      McCurdy
  - Saskatoon, Canada
    - Recruiting
    - Saskatoon Cancer Center
    - Contact:
      
      Stakiw
  - Sherbrooke, Canada
    - Recruiting
    - "Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)"
    - Contact:
      
      Pavic
  - Toronto, Canada
    - Recruiting
    - Princess Margaret Cancer Centre
    - Contact:
      
      Reece
  - Vancouver, Canada
    - Recruiting
    - BC Cancer
    - Contact:
      
      Venner
China
- - Beijing, China
    - Recruiting
    - Beijing Chaoyang Hospital
    - Contact:
      
      Wenming
  - Beijing, China
    - Recruiting
    - Peking University First Hospital
    - Contact:
      
      Yujun
  - Changchun, China
    - Recruiting
    - The First Hospital of Jilin University
    - Contact:
      
      Fengyan
  - Henan, China
    - Recruiting
    - Henan Cancer Hospital
    - Contact:
      
      Baijun
  - Shandong, China
    - Recruiting
    - Shandong Qilu Hospital
    - Contact:
      
      Peng
  - Shanghai, China
    - Recruiting
    - Shanghai Fourth People's Hospital
    - Contact:
      
      Weijun
  - Shenyang, China
    - Recruiting
    - Shengjing Hospital of China Medical University
    - Contact:
      
      Aijun
  - Tangshan, China
    - Recruiting
    - North China University of Science and Technology Affiliated Hospital.Hematology Department
    - Contact:
      
      Zhenyu
  - Tianjin, China
    - Recruiting
    - Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
    - Contact:
      
      Gang
  - Wenzhou, China
    - Recruiting
    - The First Affiliated Hospital of Wenzhou Medical University
    - Contact:
      
      Songfu
  - Wuhan, China
    - Recruiting
    - Tongji Hospital, Tongji Medical College of HUST
    - Contact:
      
      Chunrui
  - Zhejiang, China
    - Recruiting
    - The First Affiliated Hospital, Zhejiang University College of Medicine
    - Contact:
      
      Zhen
Czechia
- - Hradec Králové, Czechia
    - Recruiting
    - Fakultni nemocnice Hradec Kralove
    - Contact:
      
      Radocha
  - Olomouc, Czechia
    - Recruiting
    - University Hospital Olomouc
    - Contact:
      
      Minarik
  - Ostrava, Czechia
    - Recruiting
    - Fakultni nemocnice Ostrava
    - Contact:
      
      Hajek
  - Pilsen, Czechia
    - Recruiting
    - Fakultni nemocnice Plzen
    - Contact:
      
      Jungova
  - Prague, Czechia
    - Recruiting
    - Vseobecna fakultni nemocnice v Praze
    - Contact:
      
      Spicka
Denmark
- - Aarhus, Denmark
    - Recruiting
    - Aarhus Universitetshospital
    - Contact:
      
      Ølholm Vase
  - Copenhagen, Denmark
    - Recruiting
    - Rigshospitalet
    - Contact:
      
      Szabo
  - Odense, Denmark
    - Recruiting
    - Odense University Hospital
    - Contact:
      
      Krejcik
  - Vejle, Denmark
    - Recruiting
    - Lillebaelt Hospital
    - Contact:
      
      Farmer
France
- - Bordeaux, France
    - Recruiting
    - Centre Hospitalier Universitaire de Bordeaux
    - Contact:
      
      Hulin
  - Lille, France
    - Recruiting
    - Department of Hematology, CHU Lille
    - Contact:
      
      Manier
  - Marseille, France
    - Recruiting
    - Institut Paoli Calmettes
    - Contact:
      
      Schiano de Colella
  - Montpellier, France
    - Recruiting
    - Centre Hospitalier Universitaire de Montpellier
    - Contact:
      
      Vincent
  - Nantes, France
    - Recruiting
    - Centre Hospitalier Universitaire de Nantes
    - Contact:
      
      Moreau
  - Paris, France
    - Recruiting
    - Hôpital Saint-Antoine
    - Contact:
      
      Mohty
  - Paris, France
    - Recruiting
    - Hopital Saint Louis
    - Contact:
      
      Arnulf
  - Poitiers, France
    - Recruiting
    - Centre Hospitalier Universitaire De Poitiers
    - Contact:
      
      Leleu
  - Toulouse, France
    - Recruiting
    - Centre Hospitalier Universitaire de Toulouse
    - Contact:
      
      Perrot
Germany
- - Hamburg, Germany
    - Recruiting
    - Universitätsklinikum Hamburg - Eppendorf
    - Contact:
      
      Weisel
  - Heidelberg, Germany
    - Recruiting
    - Universitaetsklinikum Heidelberg AöR
    - Contact:
      
      Raab
  - Jena, Germany
    - Recruiting
    - Universitaetsklinikum Jena KöR
    - Contact:
      
      Yomade
  - Lübeck, Germany
    - Active, not recruiting
    - Universitaetsklinikum Schleswig-Holstein AöR
  - München, Germany
    - Recruiting
    - Klinikum rechts der Isar der TU Muenchen AöR
    - Contact:
      
      Bassermann
  - Nuremberg, Germany
    - Recruiting
    - Klinikum Nuernberg
    - Contact:
      
      Wendelin
  - Tübingen, Germany
    - Recruiting
    - Universitaetsklinikum Tuebingen AöR
    - Contact:
      
      Besemer
  - Würzburg, Germany
    - Recruiting
    - University Hospital of Würzburg
    - Contact:
      
      Rasche
Greece
- - Alexandroupoli, Greece
    - Recruiting
    - University General Hospital of Alexandroupoli
    - Contact:
      
      Spanoudakis
  - Athens, Greece
    - Recruiting
    - Regional General Hospital Alexandra
    - Contact:
      
      Terpos
  - Athens, Greece
    - Recruiting
    - Evaggelismos Hospital
    - Contact:
      
      Delimpasi
  - Thessaloniki, Greece
    - Recruiting
    - Theageneio Cancer Hospital
    - Contact:
      
      Katodrytou
Ireland
- - Cork, Ireland
    - Recruiting
    - Cork University Hospital
    - Contact:
      
      Mykytiv
  - Dublin, Ireland
    - Recruiting
    - Beaumont Hospital
    - Contact:
      
      Quinn
  - Dublin, Ireland
    - Recruiting
    - St Vincent's University Hospital
    - Contact:
      
      Coyne
  - Dublin, Ireland
    - Recruiting
    - St James's Hospital
    - Contact:
      
      Hayden
  - Galway, Ireland
    - Recruiting
    - University Hospital Galway
    - Contact:
      
      Krawczyk
  - Limerick, Ireland
    - Recruiting
    - University Hospital Limerick
    - Contact:
      
      Clifford
Israel
- - Beersheba, Israel
    - Recruiting
    - Soroka university medical center
    - Contact:
      
      Rouvio
  - Haifa, Israel
    - Recruiting
    - Health Care Campus
    - Contact:
      
      Lavi
  - Jerusalem, Israel
    - Recruiting
    - Hadassah Medical Center
    - Contact:
      
      Gatt
  - Petah Tikva, Israel
    - Recruiting
    - Beilinson Hospital
    - Contact:
      
      Vaxman
  - Ramat Gan, Israel
    - Recruiting
    - Chaim Sheba Medical Center
    - Contact:
      
      Magen
  - Tel Aviv, Israel
    - Recruiting
    - Tel-Aviv Sourasky Medical Center
    - Contact:
      
      Cohen
Italy
- - Alessandria, Italy
    - Recruiting
    - Azienda Sanitaria Locale Al Di Alessandria
    - Contact:
      
      Monaco
  - Ancona, Italy
    - Recruiting
    - Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
    - Contact:
      
      Offidani
  - Bari, Italy
    - Recruiting
    - AOU Policlinico di Bari
    - Contact:
      
      Musto
  - Bari, Italy
    - Recruiting
    - AOU G. Baccelli
    - Contact:
      
      Ria
  - Bergamo, Italy
    - Recruiting
    - ASST Papa Giovanni XXIII Hospital
    - Contact:
      
      Galli
  - Bologna, Italy
    - Recruiting
    - A.O.U. di Bologna - Policlinico S. Orsola Malpighi
    - Contact:
      
      Zamagni
  - Brescia, Italy
    - Recruiting
    - A.O.Spedali Civili di Brescia
    - Contact:
      
      Belotti
  - Cagliari, Italy
    - Recruiting
    - Ospedale Oncologico 'A. Businco'
    - Contact:
      
      Derudas
  - Cosenza, Italy
    - Recruiting
    - Azienda Ospedaliera-Universitaria Di Cosenza
    - Contact:
      
      Gentile
  - Florence, Italy
    - Recruiting
    - Careggi University Hospital
    - Contact:
      
      Antonioli
  - Genova, Italy
    - Recruiting
    - IRCCS Ospedale Policlinico San Martino
    - Contact:
      
      Aquino
  - Milan, Italy
    - Recruiting
    - IRCCS Ospedale Maggiore Policlinico
    - Contact:
      
      Bolli
  - Modena, Italy
    - Recruiting
    - Azienda Ospedaliero Universitaria Di Modena
    - Contact:
      
      Luppi
  - Naples, Italy
    - Recruiting
    - Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
    - Contact:
      
      Palmieri
  - Naples, Italy
    - Withdrawn
    - UOC Oncoematologia, Ospedale Policlinico Federico II
  - Novara, Italy
    - Recruiting
    - Azienda Ospedaliero-Universitaria Maggiore Della Carita
    - Contact:
      
      Margiotta Casaluci
  - Padova, Italy
    - Recruiting
    - UOC Ematologia - Azienda Ospedale - Università Padova Ospedale Giustinianeo
    - Contact:
      
      Zambello
  - Parma, Italy
    - Recruiting
    - Department of Hematology and Bone Marrow Transplant Centre, Azienda Ospedaliero - Universitaria di Parma
    - Contact:
      
      Giuliani
  - Pavia, Italy
    - Recruiting
    - Fondazione IRCCS Policlinico San Matteo
    - Contact:
      
      Mangiacavalli
  - Pescara, Italy
    - Recruiting
    - Ospedale Civile Spirito Santo di Pescara
    - Contact:
      
      Liberatore
  - Ravenna, Italy
    - Recruiting
    - Ospedale Santa Maria delle Croci
    - Contact:
      
      Cellini
  - Reggio Emilia, Italy
    - Recruiting
    - Azienda USL IRCCS Di Reggio Emilia
    - Contact:
      
      Gamberi
  - Rimini, Italy
    - Recruiting
    - Ospedale "Infermi" di Rimini
    - Contact:
      
      Tosi
  - Roma, Italy
    - Recruiting
    - Ematologia, Azienda Policlinico Umberto I
    - Contact:
      
      Martelli
  - San Giovanni Rotondo, Italy
    - Recruiting
    - Casa Sollievo Della Sofferenza
    - Contact:
      
      Falcone
  - Torino, Italy, 10126
    - Recruiting
    - A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
    - Contact:
      
      Gay
  - Trieste, Italy
    - Recruiting
    - A.O.U. Ospedali Riuniti di Trieste
    - Contact:
      
      Zaja
  - Udine, Italy
    - Recruiting
    - Ospedale S. Maria della Misericordia di Udine
    - Contact:
      
      Patriarca
Netherlands
- - Alkmaar, Netherlands
    - Recruiting
    - Noordwest ziekenhuisgroep
    - Contact:
      
      Westerman
  - Amsterdam, Netherlands
    - Recruiting
    - Amsterdam University Medical Center
    - Contact:
      
      Van der Donk
  - Dordrecht, Netherlands
    - Recruiting
    - Albert Schweitzer Ziekenhuis
    - Contact:
      
      Levin
  - Eindhoven, Netherlands
    - Recruiting
    - Máxima Medisch Centrum
    - Contact:
      
      Nieuwenhuizen
  - Groningen, Netherlands
    - Recruiting
    - University Medical Center Groningen
    - Contact:
      
      Roeloffzen
  - Hoorn, Netherlands
    - Recruiting
    - Dijklander Ziekenhuis
    - Contact:
      
      Klerk
  - Nieuwegein, Netherlands
    - Recruiting
    - St. Antonius Ziekenhuis
    - Contact:
      
      Nijhoff
  - Rotterdam, Netherlands
    - Recruiting
    - Erasmus University Medical Center Rotterdam
    - Contact:
      
      Wester
  - Rotterdam, Netherlands
    - Recruiting
    - Maasstad Ziekenhuis
    - Contact:
      
      Sprenger
Norway
- - Trondheim, Norway
    - Recruiting
    - St. Olavs hospital HF
    - Contact:
      
      Slørdahl
Poland
- - Gdansk, Poland
    - Recruiting
    - Department of Hematology and Transplantology University Clinical Center
    - Contact:
      
      Tyczynska
  - Poznan, Poland
    - Recruiting
    - Uniwersytecki Szpital Kliniczny W Poznaniu
    - Contact:
      
      Dytfeld
Portugal
- - Braga, Portugal
    - Withdrawn
    - CCAB Centro Clinico Academico Braga Associacao
  - Lisbon, Portugal
    - Recruiting
    - Champalimaud Clinical Centre
    - Contact:
      
      João
  - Lisbon, Portugal
    - Withdrawn
    - Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
  - Porto, Portugal
    - Withdrawn
    - Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
  - Porto, Portugal
    - Withdrawn
    - Unidade Local De Saude De Gaia/Espinho E.P.E.
  - Porto, Portugal
    - Withdrawn
    - Sao Joao University Hospital Center
  - Vila Real, Portugal
    - Recruiting
    - Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
    - Contact:
      
      Ferraz
Serbia
- - Belgrade, Serbia
    - Recruiting
    - University Clinical Center of Serbia
    - Contact:
      
      Bila
  - Kragujevac, Serbia
    - Recruiting
    - Clinical Centre of Kragujevac
    - Contact:
      
      Djurdjevic
  - Niš, Serbia
    - Recruiting
    - Clinical Centre of Nis
    - Contact:
      
      Vucic
  - Novi Sad, Serbia
    - Recruiting
    - Clinical Centre of Vojvodina
    - Contact:
      
      Savic
South Korea
- - Gwangju, South Korea
    - Recruiting
    - Chonnam National University Hwasun Hospital
    - Contact:
      
      Jung
  - Seoul, South Korea
    - Recruiting
    - Samsung Medical Center
    - Contact:
      
      Kim
  - Seoul, South Korea
    - Recruiting
    - Severance Hospital
    - Contact:
      
      Kim
  - Seoul, South Korea
    - Recruiting
    - Seoul National University Hospital, Internal Medicine
    - Contact:
      
      Koh
  - Seoul, South Korea
    - Recruiting
    - St. Mary's Hospital
    - Contact:
      
      Min
  - Seoul, South Korea
    - Recruiting
    - Department of Oncology, Asan Medical Center
    - Contact:
      
      Yoon
Switzerland
- - Basel, Switzerland
    - Recruiting
    - University Hospital Basel
    - Contact:
      
      Heim
  - Bern, Switzerland
    - Recruiting
    - Inselspital
    - Contact:
      
      Pabst
  - Sankt Gallen, Switzerland
    - Recruiting
    - Kantonsspital St. Gallen
    - Contact:
      
      Hess-Mildenberger
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye)
    - Recruiting
    - Ankara Liv Hospital
    - Contact:
      
      Beksac
  - Ankara, Turkey (Türkiye)
    - Recruiting
    - Ankara University Hospital
    - Contact:
      
      Cengiz-Seval
  - Istanbul, Turkey (Türkiye)
    - Recruiting
    - Florence Nightingale Hospital
    - Contact:
      
      Sevindik
  - Istanbul, Turkey (Türkiye)
    - Recruiting
    - Memorial Sisli Hospital, Dept of Hematology
    - Contact:
      
      Arat
  - Izmir, Turkey (Türkiye)
    - Recruiting
    - Ege University Medical faculty Hospital Internal Medicine Department Adult Hematology Unit
    - Contact:
      
      Vural
  - Izmir, Turkey (Türkiye)
    - Not yet recruiting
    - Izmir Economy University, Medical Point Hospital
    - Contact:
      
      Cagirgan
  - Kayseri, Turkey (Türkiye)
    - Recruiting
    - Erciyes University Hospital
    - Contact:
      
      Mandaci
United Kingdom
- - London, United Kingdom
    - Recruiting
    - University College London (UCL)
    - Contact:
      
      Rabin
  - London, United Kingdom
    - Recruiting
    - Hammersmith Hospital - Imperial College NHS Healthcare Trust
    - Contact:
      
      Atta
  - Sutton, United Kingdom
    - Recruiting
    - The Royal Marsden Hospital
    - Contact:
      
      Boyd
United States
- Arizona
  - Phoenix, Arizona, United States, 85004
    - Recruiting
    - Banner University Medical Center Tucson, University of Arizona
    - Contact:
      
      Husnain
- California
  - Los Angeles, California, United States, 90095
    - Not yet recruiting
    - UCLA Medical Center
    - Contact:
      
      Lin
  - Sacramento, California, United States, 95817
    - Recruiting
    - University of California-Davis Cancer Center
    - Contact:
      
      Rosenberg
  - San Diego, California, United States, 92093
    - Recruiting
    - University of California, San Diego (UCSD) Medical Center
    - Contact:
      
      Jeong
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - University of Colorado Hospital
    - Contact:
      
      Monge Urrea
  - Denver, Colorado, United States, 80218
    - Recruiting
    - Colorado Blood Cancer Institute
    - Contact:
      
      Matous
- Connecticut
  - New Haven, Connecticut, United States, 06519
    - Recruiting
    - Yale New Haven Hospital
    - Contact:
      
      Neparidze
- Delaware
  - Newark, Delaware, United States, 19718
    - Recruiting
    - Christiana Care
    - Contact:
      
      Misleh
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20016
    - Recruiting
    - Sibley Memorial Hospital
    - Contact:
      
      Waheed
- Florida
  - Orlando, Florida, United States, 32804
    - Recruiting
    - AdventHealth/Blood & Marrow Transplant Center, Florida Hospital Medical Group
    - Contact:
      
      Gayle
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt at Memorial Healthcare System
    - Contact:
      
      Nguyen
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Emory University Hospital
    - Contact:
      
      Mina
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - University of Illinois Medical Center at Chicago
    - Contact:
      
      Sanchez
  - Chicago, Illinois, United States, 3000168
    - Not yet recruiting
    - University of Chicago
    - Contact:
      
      Cooperrider
- Maryland
  - Baltimore, Maryland, United States, 21218
    - Recruiting
    - John Hopkins
    - Contact:
      
      Gocke
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - Greenebaum Cancer Center UM of MD
    - Contact:
      
      Badros
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center
    - Contact:
      
      Liegel
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Tufts Medical Center
    - Contact:
      
      Bhatt
- Michigan
  - Grosse Pointe Woods, Michigan, United States, 3000169
    - Not yet recruiting
    - Henry Ford St. John Hospital
    - Contact:
      
      Lebovic
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Withdrawn
    - Dartmouth-Hitchcock Medical Center
- New York
  - New York, New York, United States, 10029
    - Recruiting
    - Mount Sinai Medical Center - 2
    - Contact:
      
      Rodriguez
  - The Bronx, New York, United States, 10467
    - Recruiting
    - Montefiore Medical Cente
    - Contact:
      
      Levitz
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Levine Cancer Institute
    - Contact:
      
      Bhutani
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University
    - Contact:
      
      Gasparetto
  - Greenville, North Carolina, United States, 27858
    - Not yet recruiting
    - East Carolina University
    - Contact:
      
      Liles
- Ohio
  - Cincinnati, Ohio, United States, 45221
    - Recruiting
    - University of Cincinnati
    - Contact:
      
      Faber
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - Seidman Cancer Center-University Hospitals Cleveland Medical Center
    - Contact:
      
      Ignatz-Hoover
  - Columbus, Ohio, United States, 43214
    - Recruiting
    - Ohio Health Research Institute
    - Contact:
      
      Efebera
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Ohio State Medical Center, James Cancer Center
    - Contact:
      
      Cottini
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Recruiting
    - Lehigh Valley Health Network
    - Contact:
      
      Lash
  - Lancaster, Pennsylvania, United States, 17602
    - Not yet recruiting
    - Penn Medicine Lancaster General
    - Contact:
      
      Abdulkareem
  - Philadelphia, Pennsylvania, United States, 19111
    - Recruiting
    - Fox Chase Cancer Center
    - Contact:
      
      Varshavsky-Yanovsky
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Abramson Cancer Center University of Pennsylvania Medical Center
    - Contact:
      
      Garfall
  - Pittsburgh, Pennsylvania, United States, 15232
    - Not yet recruiting
    - UPMC Hillman Cancer Center
    - Contact:
      
      Dorritie
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina (MUSC)
    - Contact:
      
      Dominick
  - Spartanburg, South Carolina, United States, 29303
    - Recruiting
    - Gibbs Cancer Center
    - Contact:
      
      Buck
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt-Ingram Cancer Center (VICC)
    - Contact:
      
      Biltibo
- Texas
  - Houston, Texas, United States, 77030
    - Recruiting
    - Houston Methodist Hospital
    - Contact:
      
      Ganguly
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Recruiting
    - Virginia Oncology Associates
    - Contact:
      
      Cross
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - Recruiting
    - St Vincent HSHS (Green Bay Oncology)
    - Contact:
      
      Burnette
  - Madison, Wisconsin, United States, 53792
    - Recruiting
    - University of Wisconsin Hospital and Clinics
    - Contact:
      
      Callander
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Froedtert Memorial Lutheran Hospital
    - Contact:
      
      Dhakal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Received any prior BCMA-directed therapy.
Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
Progressed on multiple myeloma therapy at any time prior to screening.
Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm Participant Group / Arm A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.	Intervention / Treatment Intervention / Treatment A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm B Lenalidomide Alone (Len) Lenalidomide orally.	Drug: Lenalidomide Lenalidomide will be administered orally
Experimental: Arm A: Teclistamab-Lenalidomide (Tec-Len) Teclistamab will be administered via a subcutaneous injection (SC)	Drug: Teclistamab Teclistamab will be administered via a subcutaneous injection (SC) Other Names: JNJ-64007957 Drug: Lenalidomide Lenalidomide will be administered orally
Experimental: Arm C Teclistamab-Alone (Tec) Teclistamab will be administered via a subcutaneous injection (SC)	Drug: Teclistamab Teclistamab will be administered via a subcutaneous injection (SC) Other Names: JNJ-64007957

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) Time Frame: from randomization to the date of disease progression or death (approximately up to 8 years)	PFS is defined as the time from the date of randomization to the date of disease progression (as assessed by IMWG criteria) or death due to any cause, whichever occurs first.	from randomization to the date of disease progression or death (approximately up to 8 years)
Minimal Residual Disease (MRD)-negative Complete Response (CR) Time Frame: at month 12	12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation flow cytometry (NGF) with sensitivity of 10^-5, prior to progressive disease or subsequent anti-myeloma therapy, whichever is earlier, and who also achieve CR of better, according to IMWG criteria.	at month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: from the date of from randomization to the date the subject's death, assessed up to 8 years]	Overall Survival (OS), measured from the date of from randomization to the date the subject's death	from the date of from randomization to the date the subject's death, assessed up to 8 years]
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms Time Frame: baseline up to 8 years	The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.	baseline up to 8 years
EQ-5D-5L health utility values and the difference between-treatment arms Time Frame: baseline up to 8 years	The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"	baseline up to 8 years
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms Time Frame: baseline up to 8 years	The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale.	baseline up to 8 years
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms Time Frame: baseline up to week 24	The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The PRO-CTCAE Item Library includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE	baseline up to week 24
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms Time Frame: baseline up to 8 years	PGIS is a 1 item questionnaire that evaluates patients' health and assesses if there has been an improvement or decline in clinical status	baseline up to 8 years
Comparison of efficacy Time Frame: from randomization to the date of disease progression or death (approximately up to 8 years)	Efficacy, assessed by rate of CR or better, MRD negative CR, sustained MRD negativity, CR and MRD negative conversion PFS after next line of therapy (PFS2), time to next treatment (TTNT), OS and also safety, PK and immunogenicity	from randomization to the date of disease progression or death (approximately up to 8 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Myeloma Network B.V.

Collaborators

Janssen Pharmaceutica

Investigators

Principal Investigator: Niels van de Donk, Professor, Amsterdam UMC, Vrije Universiteit Amsterdam
Principal Investigator: Elena Zamagni, Professor, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

EMN30/64007957MMY3003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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