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
1 other identifier
interventional
1,594
24 countries
201
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Sep 2022
Longer than P75 for phase_3 multiple-myeloma
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedStudy Start
First participant enrolled
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2032
March 25, 2026
February 1, 2026
5.6 years
January 27, 2022
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS)
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)
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 Outcomes (7)
Comparison of efficacy
from randomization to the date of disease progression or death (approximately up to 8 years)
Overall Survival (OS)
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
baseline up to 8 years
EQ-5D-5L health utility values and the difference between-treatment arms
baseline up to 8 years
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms
baseline up to 8 years
- +2 more secondary outcomes
Study Arms (3)
Arm A: Teclistamab-Lenalidomide (Tec-Len)
EXPERIMENTALTeclistamab will be administered via a subcutaneous injection (SC)
Arm B Lenalidomide Alone (Len)
ACTIVE COMPARATORLenalidomide orally.
Arm C Teclistamab-Alone (Tec)
EXPERIMENTALTeclistamab will be administered via a subcutaneous injection (SC)
Interventions
Teclistamab will be administered via a subcutaneous injection (SC)
Lenalidomide will be administered orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- European Myeloma Network B.V.lead
- Janssen Pharmaceuticacollaborator
Study Sites (211)
Banner University Medical Center Tucson, University of Arizona
Phoenix, Arizona, 85004, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
University of California-Davis Cancer Center
Sacramento, California, 95817, United States
University of California, San Diego (UCSD) Medical Center
San Diego, California, 92093, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
Christiana Care
Newark, Delaware, 19718, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Blood & Marrow Transplant Center, Florida Hospital Medical Group
Orlando, Florida, 32804, United States
Moffitt at Memorial Healthcare System
Tampa, Florida, 33612, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Illinois Medical Center at Chicago
Chicago, Illinois, 60612, United States
Greenebaum Cancer Center UM of MD
Baltimore, Maryland, 21201, United States
John Hopkins
Baltimore, Maryland, 21218, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Mount Sinai Medical Center - 2
New York, New York, 10029, United States
Montefiore Medical Cente
The Bronx, New York, 10467, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27708, United States
East Carolina University
Greenville, North Carolina, 27858, United States
University of Cincinnati
Cincinnati, Ohio, 45221, United States
Seidman Cancer Center-University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio State Medical Center, James Cancer Center
Columbus, Ohio, 43210, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Penn Medicine Lancaster General
Lancaster, Pennsylvania, 17602, United States
Abramson Cancer Center University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Gibbs Cancer Center
Spartanburg, South Carolina, 29303, United States
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, 37240, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
St Vincent HSHS (Green Bay Oncology)
Green Bay, Wisconsin, 54301, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, United States
Hospital Italiano
Buenos Aires, Argentina
Hospital Privado
Córdoba, Argentina
Sanatorio Britanico Rosario
Rosario, Argentina
Sunshine Coast Health
Birtinya, Queensland, Australia
Flinders Medical Centre
Adelaide, Australia
Townsville University Hospital
Douglas, Australia
Barwon Health University Hospital Geelong Andrew Love Cancer Centre
Geelong, Australia
Alfred Hospital
Melbourne, Australia
Austin Health
Melbourne, Australia
Calvary Mater Hospital
Newcastle, Australia
Sunshine Coast Health
Sunshine Coast, Australia
Concord Repatriation General Hospital
Sydney, Australia
Royal North Shore Hospital
Sydney, Australia
Landeskrankenhaus, Feldkirch
Feldkirch, Austria
Medizinische Universitaet Innsbruck
Innsbruck, Austria
University Hospital Krems/Donau
Krems, Austria
Kepler Universitätsklinikum Med Campus III
Linz, Austria
Ordensklinikum Linz GmbH
Linz, Austria
Uniklinikum Salzburg
Salzburg, Austria
Clinic Ottakring
Vienna, Austria
LKH Hochsteiermark
Vienna, Austria
Jessa Ziekenhuis
Hasselt, Belgium
Department of Hematology, CH Jolimont
La Louvière, Belgium
Algemeen Ziekenhuis Delta
Leuven, Belgium
University Hospital Leuven
Leuven, Belgium
Centre hospitalier universitaire de Liege
Liège, Belgium
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, Brazil
Hospital Santa Rita
Porto Alegre, Brazil
Instituto Americas de Ensino,Pesquisa e Inovação
Rio de Janeiro, Brazil
IDOR- Instituto D'or de pesquisa. Av. São Rafael
Salvador, Brazil
A Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, Brazil
Clínica Medica São Germano,Grupo Oncoclínicas Pesquisa Clínica
São Paulo, Brazil
Departamento de Oncologia Clínica AC Camargo Cancer Center
São Paulo, Brazil
Grupo Oncoclínicas Pesquisa Clínica
São Paulo, Brazil
Hcor, Associacao Siria
São Paulo, Brazil
Hemocentro UNICAMP, Universidade Estadual de Campinas
São Paulo, Brazil
Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil
Hospital Paulistano, Centro de Pesquisa Clinica R. Martiniano de Carvalho
São Paulo, Brazil
Onco Star
São Paulo, Brazil
Universidade Federal de São Paulo - Hospital São Paulo
São Paulo, Brazil
Cross Cancer Institute
Edmonton, Canada
QEII Health Sciences Centre
Halifax, Canada
The Ottawa General Hospital
Ottawa, Canada
Saskatoon Cancer Center
Saskatoon, Canada
"Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)"
Sherbrooke, Canada
Princess Margaret Cancer Centre
Toronto, Canada
BC Cancer
Vancouver, Canada
Beijing Chaoyang Hospital
Beijing, China
Peking University First Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
North China University of Science and Technology Affiliated Hospital.Hematology Department
Hebei, China
Henan Cancer Hospital
Henan, China
Shandong Qilu Hospital
Shandong, China
Shanghai Fourth People's Hospital
Shanghai, China
Shenyang City, Liaoning Province, Hematology department
Shenyang, China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital, Tongji Medical College of Hust
Wuhan, China
The First Affiliated Hospital, Zhejiang University College of Medicine
Zhejiang, China
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
University Hospital Olomouc
Olomouc, Czechia
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Fakultni Nemocnice Plzen
Pilsen, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Aarhus Universitetshospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Lillebaelt Hospital
Vejle, Denmark
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Department of Hematology, CHU Lille
Lille, France
Institut Paoli Calmettes
Marseille, France
Centre Hospitalier Universitaire De Montpellier
Montpellier, France
Centre Hospitalier Universitaire De Nantes
Nantes, France
Hopital Saint Louis
Paris, France
Hôpital Saint-Antoine
Paris, France
Centre Hospitalier Universitaire De Poitiers
Poitiers, France
Centre Hospitalier Universitaire De Toulouse
Toulouse, France
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany
Universitaetsklinikum Jena KöR
Jena, Germany
Universitaetsklinikum Schleswig-Holstein AöR
Lübeck, Germany
Klinikum rechts der Isar der TU Muenchen AöR
München, Germany
Klinikum Nuernberg
Nuremberg, Germany
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany
University Hospital of Würzburg
Würzburg, Germany
University General Hospital Of Alexandroupoli
Alexandroupoli, Greece
Evaggelismos Hospital
Athens, Greece
Regional General Hospital Alexandra
Athens, Greece
Theageneio Cancer Hospital
Thessaloniki, Greece
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
St Vincent's University Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
University Hospital Limerick
Limerick, Ireland
The Barzilai Medical Center
Beersheba, Israel
Health Care Campus
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Beilinson Hospital
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Azienda Sanitaria Locale Al Di Alessandria
Alessandria, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Ancona, Italy
AOU G. Baccelli
Bari, Italy
Policlinico di Bari
Bari, Italy
A.O. Papa Giovanni XXIII
Bergamo, Italy
A.O.U. di Bologna - Policlinico S. Orsola Malpighi
Bologna, Italy
A.O.Spedali Civili di Brescia
Brescia, Italy
Ospedale Oncologico 'A. Businco'
Cagliari, Italy
Azienda Ospedaliera-Universitaria Di Cosenza
Cosenza, Italy
Careggi University Hospital
Florence, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
IRCCS Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Naples, Italy
UOC Oncoematologia, Ospedale Policlinico Federico II
Naples, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, Italy
UOC Ematologia - Azienda Ospedale - Università Padova Ospedale Giustinianeo
Padua, Italy
Department of Hematology and Bone Marrow Transplant Centre, Azienda Ospedaliero - Universitaria di Parma
Parma, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Sanitaria Locale Di Pescara
Pescara, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Azienda USL IRCCS Di Reggio Emilia
Reggio, Italy
Ospedale "Infermi" di Rimini
Rimini, Italy
Ematologia, Azienda Policlinico Umberto I
Roma, Italy
Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
Torino, 10126, Italy
A.O.U. Ospedali Riuniti di Trieste
Trieste, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Noordwest Ziekenhuisgroep Stichting
Alkmaar, Netherlands
Amsterdam University Medical Center
Amsterdam, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Dijklander Ziekenhuis
Hoorn, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
St. Olavs hospital HF
Trondheim, Norway
Department of Hematology and Transplantology University Clinical Center
Gdansk, Poland
SPZOZ MSWiA w Poznaniu im. Prof. Ludwika Bierkowskiego, Poznań
Poznan, Poland
CCAB Centro Clinico Academico Braga Associacao
Braga, Portugal
Champalimaud Clinical Centre
Lisbon, Portugal
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Lisbon, Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Porto, Portugal
Sao Joao University Hospital Center
Porto, Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E.
Porto, Portugal
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Vila Real, Portugal
University Clinical Center of Serbia
Belgrade, Serbia
Clinical Centre of Kragujevac
Kragujevac, Serbia
Clinical Centre of Nis
Niš, Serbia
Clinical Centre of Vojvodina
Novi Sad, Serbia
Chonnam National University Hwasun Hospital
Gwangju, South Korea
Department of Oncology, Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital, Internal Medicine
Seoul, South Korea
Severance Hospital
Seoul, South Korea
St. Mary's Hospital
Seoul, South Korea
University Hospital Basel
Basel, Switzerland
Inselspital
Bern, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Ankara Liv Hospital
Ankara, Turkey (Türkiye)
Ankara University Hospital
Ankara, Turkey (Türkiye)
Florence Nightingale Hospital
Istanbul, Turkey (Türkiye)
Memorial Sisli Hospital, Dept of Hematology
Istanbul, Turkey (Türkiye)
Ege University Medical faculty Hospital Internal Medicine Department Adult Hematology Unit
Izmir, Turkey (Türkiye)
Izmir Economy University, Medical Point Hospital
Izmir, Turkey (Türkiye)
Erciyes University Hospital
Kayseri, Turkey (Türkiye)
Hammersmith Hospital - Imperial College NHS Healthcare Trust
London, United Kingdom
University College London (UCL)
London, United Kingdom
The Royal Marsden Hospital
Sutton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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"
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 17, 2022
Study Start
September 8, 2022
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2032
Last Updated
March 25, 2026
Record last verified: 2026-02