Multiple MyelomaPhase 3MajesTEC-4NCT05243797
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
A Phase 3 study testing Teclistamab and Lenalidomide in people with Multiple Myeloma, run by European Myeloma Network B.V. at 212 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Teclistamab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,594 participants
- Where
- 212 sitesin 25 countries
- Study dates
- 8 Sep 2022to Apr 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
212 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
212 sites in 25 countries
United States42 sites, 39 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Lash
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Mina
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Monge Urrea
- Recruiting
Greenebaum Cancer Center UM of MD
Baltimore, Maryland, 21201
Badros
- Recruiting
John Hopkins
Baltimore, Maryland, 21218
Gocke
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Bhatt
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Liegel
- Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Dominick
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Bhutani
- Recruiting
University of Chicago
Chicago, Illinois, 3000168
Cooperrider
- Recruiting
University of Illinois Medical Center at Chicago
Chicago, Illinois, 60612
Sanchez
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45221
Faber
- Recruiting
Seidman Cancer Center-University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ignatz-Hoover
- Recruiting
Ohio State Medical Center, James Cancer Center
Columbus, Ohio, 43210
Cottini
- Recruiting
Ohio Health Research Institute
Columbus, Ohio, 43214
Efebera
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Matous
- Recruiting
Duke University
Durham, North Carolina, 27710
Gasparetto
- Recruiting
St Vincent HSHS (Green Bay Oncology)
Green Bay, Wisconsin, 54301
Burnette
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Liles
- Withdrawn
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, 3000169
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Ganguly
- Recruiting
Penn Medicine Lancaster General
Lancaster, Pennsylvania, 17602
Abdulkareem
- Withdrawn
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
- Recruiting
UCLA Medical Center
Los Angeles, California, 90095
Lin
- Recruiting
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Callander
- Recruiting
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Dhakal
- Recruiting
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, 37232
Biltibo
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06519
Neparidze
- Recruiting
Mount Sinai Medical Center - 2
New York, New York, 10029
Rodriguez
- Recruiting
Christiana Care
Newark, Delaware, 19718
Misleh
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cross
- Recruiting
AdventHealth/Blood & Marrow Transplant Center, Florida Hospital Medical Group
Orlando, Florida, 32804
Gayle
- Recruiting
Abramson Cancer Center University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Garfall
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Varshavsky-Yanovsky
- Recruiting
Banner University Medical Center Tucson, University of Arizona
Phoenix, Arizona, 85004
Husnain
- Withdrawn
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
University of California-Davis Cancer Center
Sacramento, California, 95817
Rosenberg
- Recruiting
University of California, San Diego (UCSD) Medical Center
San Diego, California, 92093
Jeong
- Recruiting
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Buck
- Recruiting
Moffitt at Memorial Healthcare System
Tampa, Florida, 33612
Nguyen
- Recruiting
Montefiore Medical Cente
The Bronx, New York, 10467
Levitz
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Waheed
Italy28 sites, 27 recruiting
- Recruiting
Azienda Sanitaria Locale Al Di Alessandria
Alessandria
Monaco
- Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Ancona
Offidani
- Recruiting
AOU G. Baccelli
Bari
Ria
- Recruiting
AOU Policlinico di Bari
Bari
Musto
- Recruiting
ASST Papa Giovanni XXIII Hospital
Bergamo
Galli
- Recruiting
A.O.U. di Bologna - Policlinico S. Orsola Malpighi
Bologna
Zamagni
- Recruiting
A.O.Spedali Civili di Brescia
Brescia
Belotti
- Recruiting
Ospedale Oncologico 'A. Businco'
Cagliari
Derudas
- Recruiting
Azienda Ospedaliera-Universitaria Di Cosenza
Cosenza
Gentile
- Recruiting
Careggi University Hospital
Florence
Antonioli
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova
Aquino
- Recruiting
IRCCS Ospedale Maggiore Policlinico
Milan
Bolli
- Recruiting
Azienda Ospedaliero Universitaria Di Modena
Modena
Luppi
- Recruiting
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Naples
Palmieri
- Withdrawn
UOC Oncoematologia, Ospedale Policlinico Federico II
Naples
- Recruiting
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara
Margiotta Casaluci
- Recruiting
UOC Ematologia - Azienda Ospedale - Università Padova Ospedale Giustinianeo
Padova
Zambello
- Recruiting
Department of Hematology and Bone Marrow Transplant Centre, Azienda Ospedaliero - Universitaria di Parma
Parma
Giuliani
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Mangiacavalli
- Recruiting
Ospedale Civile Spirito Santo di Pescara
Pescara
Liberatore
- Recruiting
Ospedale Santa Maria delle Croci
Ravenna
Cellini
- Recruiting
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia
Gamberi
- Recruiting
Ospedale "Infermi" di Rimini
Rimini
Tosi
- Recruiting
Ematologia, Azienda Policlinico Umberto I
Roma
Martelli
- Recruiting
Casa Sollievo Della Sofferenza
San Giovanni Rotondo
Falcone
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
Torino, 10126
Gay
- Recruiting
A.O.U. Ospedali Riuniti di Trieste
Trieste
Zaja
- Recruiting
Ospedale S. Maria della Misericordia di Udine
Udine
Patriarca
Brazil14 sites, 12 recruiting
- Recruiting
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre
Capra
- Recruiting
Hospital Santa Rita
Porto Alegre
Vanelli Costa
- Recruiting
Instituto Americas de Ensino,Pesquisa e Inovação
Rio de Janeiro
Maiolino
- Recruiting
IDOR- Instituto D'or de pesquisa. Av. São Rafael
Salvador
Queiroz Crusoe
- Recruiting
A Real e Benemérita Associação Portuguesa de Beneficência
São Paulo
Leão Cordeiro de Farias
- Recruiting
Clínica Medica São Germano,Grupo Oncoclínicas Pesquisa Clínica
São Paulo
Tietsche de Moraes Hungria
- Recruiting
Departamento de Oncologia Clínica AC Camargo Cancer Center
São Paulo
Schmidt Filho
- Withdrawn
Grupo Oncoclínicas Pesquisa Clínica
São Paulo
- Recruiting
Hcor, Associacao Siria
São Paulo
Lemos - Moura
- Recruiting
Hemocentro UNICAMP, Universidade Estadual de Campinas
São Paulo
Vieira Pericole
- Recruiting
Hospital das Clínicas da Universidade de São Paulo
São Paulo
Giancarlo Fatobene
- Withdrawn
Hospital Paulistano, Centro de Pesquisa Clinica R. Martiniano de Carvalho
São Paulo
- Recruiting
Onco Star
São Paulo
Costa Neto
- Recruiting
Universidade Federal de São Paulo - Hospital São Paulo
São Paulo
Braga
China12 sites, 12 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing
Wenming
- Recruiting
Peking University First Hospital
Beijing
Yujun
- Recruiting
The First Hospital of Jilin University
Changchun
Fengyan
- Recruiting
Henan Cancer Hospital
Henan
Baijun
- Recruiting
Shandong Qilu Hospital
Shandong
Peng
- Recruiting
Shanghai Fourth People's Hospital
Shanghai
Weijun
- Recruiting
Shengjing Hospital of China Medical University
Shenyang
Aijun
- Recruiting
North China University of Science and Technology Affiliated Hospital.Hematology Department
Tangshan
Zhenyu
- Recruiting
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin
Gang
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Songfu
- Recruiting
Tongji Hospital, Tongji Medical College of Hust
Wuhan
Chunrui
- Recruiting
The First Affiliated Hospital, Zhejiang University College of Medicine
Zhejiang
Zhen
Australia9 sites, 9 recruiting
- Recruiting
Flinders Medical Centre
Adelaide
Turner
- Recruiting
Sunshine Coast Health
Birtinya
Wallington - Gates
- Recruiting
Townsville University Hospital
Douglas
Lai
- Recruiting
Barwon Health University Hospital Geelong Andrew Love Cancer Centre
Geelong
Li
- Recruiting
Alfred Hospital
Melbourne
Spencer
Spencer
- Recruiting
Austin Health
Melbourne
Hocking
- Recruiting
Calvary Mater Hospital
Newcastle
Thant
- Recruiting
Concord Repatriation General Hospital
Sydney
Wong Doo
- Recruiting
Royal North Shore Hospital
Sydney
Kerridge
France9 sites, 9 recruiting
- Recruiting
Centre Hospitalier Universitaire De Bordeaux
Bordeaux
Hulin
- Recruiting
Department of Hematology, CHU Lille
Lille
Manier
- Recruiting
Institut Paoli Calmettes
Marseille
Schiano de Colella
- Recruiting
Centre Hospitalier Universitaire De Montpellier
Montpellier
Vincent
- Recruiting
Centre Hospitalier Universitaire De Nantes
Nantes
Moreau
- Recruiting
Hopital Saint Louis
Paris
Arnulf
- Recruiting
Hôpital Saint-Antoine
Paris
Mohty
- Recruiting
Centre Hospitalier Universitaire De Poitiers
Poitiers
Leleu
- Recruiting
Centre Hospitalier Universitaire De Toulouse
Toulouse
Perrot
Netherlands9 sites, 9 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
Westerman
- Recruiting
Amsterdam University Medical Center
Amsterdam
Van der Donk
- Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht
Levin
- Recruiting
Maxima Medisch Centrum
Eindhoven
Nieuwenhuizen
- Recruiting
University Medical Center Groningen
Groningen
Roeloffzen
- Recruiting
Dijklander Ziekenhuis
Hoorn
Klerk
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein
Nijhoff
- Recruiting
Erasmus University Medical Center Rotterdam
Rotterdam
Wester
- Recruiting
Maasstad Ziekenhuis
Rotterdam
Sprenger
Austria8 sites, 8 recruiting
- Recruiting
Landeskrankenhaus, Feldkirch
Feldkirch
Hartmann
- Recruiting
Medizinische Universitaet Innsbruck
Innsbruck
Willenbacher
- Recruiting
University Hospital Krems/Donau
Krems
Podar
- Recruiting
Kepler Universitätsklinikum Med Campus III
Linz
Schmitt
- Recruiting
Ordensklinikum Linz GmbH
Linz
Strassl
- Recruiting
Uniklinikum Salzburg
Salzburg
Melchardt
- Recruiting
Clinic Ottakring
Vienna
Schreder
- Recruiting
LKH Hochsteiermark
Vienna
Thamer
Germany8 sites, 7 recruiting
- Recruiting
Universitätsklinikum Hamburg - Eppendorf
Hamburg
Weisel
- Recruiting
Universitaetsklinikum Heidelberg AöR
Heidelberg
Raab
- Recruiting
Universitaetsklinikum Jena KöR
Jena
Yomade
- Active, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
Lübeck
- Recruiting
Klinikum rechts der Isar der TU Muenchen AöR
München
Bassermann
- Recruiting
Klinikum Nuernberg
Nuremberg
Wendelin
- Recruiting
Universitaetsklinikum Tuebingen AöR
Tübingen
Besemer
- Recruiting
University Hospital of Würzburg
Würzburg
Rasche
Canada7 sites, 7 recruiting
- Recruiting
Cross Cancer Institute
Edmonton
Sandhu
- Recruiting
QEII Health Sciences Centre
Halifax
de la Torre
- Recruiting
The Ottawa General Hospital
Ottawa
McCurdy
- Recruiting
Saskatoon Cancer Center
Saskatoon
Stakiw
- Recruiting
"Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)"
Sherbrooke
Pavic
- Recruiting
Princess Margaret Cancer Centre
Toronto
Reece
- Recruiting
BC Cancer
Vancouver
Venner
Portugal7 sites, 2 recruiting
- Withdrawn
CCAB Centro Clinico Academico Braga Associacao
Braga
- Recruiting
Champalimaud Clinical Centre
Lisbon
João
- Withdrawn
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Lisbon
- Withdrawn
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Porto
- Withdrawn
Sao Joao University Hospital Center
Porto
- Withdrawn
Unidade Local De Saude De Gaia/Espinho E.P.E.
Porto
- Recruiting
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Vila Real
Ferraz
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Ankara Liv Hospital
Ankara
Beksac
- Recruiting
Ankara University Hospital
Ankara
Cengiz-Seval
- Recruiting
Florence Nightingale Hospital
Istanbul
Sevindik
- Recruiting
Memorial Sisli Hospital, Dept of Hematology
Istanbul
Arat
- Recruiting
Ege University Medical faculty Hospital Internal Medicine Department Adult Hematology Unit
Izmir
Vural
- Not yet recruiting
Izmir Economy University, Medical Point Hospital
Izmir
Cagirgan
- Recruiting
Erciyes University Hospital
Kayseri
Mandaci
Ireland6 sites, 6 recruiting
- Recruiting
Cork University Hospital
Cork
Mykytiv
- Recruiting
Beaumont Hospital
Dublin
Quinn
- Recruiting
St James's Hospital
Dublin
Hayden
- Recruiting
St Vincent's University Hospital
Dublin
Coyne
- Recruiting
University Hospital Galway
Galway
Krawczyk
- Recruiting
University Hospital Limerick
Limerick
Clifford
Israel6 sites, 6 recruiting
- Recruiting
Soroka University Medical Center
Beersheba
Rouvio
- Recruiting
Health Care Campus
Haifa
Lavi
- Recruiting
Hadassah Medical Center
Jerusalem
Gatt
- Recruiting
Beilinson Hospital
Petah Tikva
Vaxman
- Recruiting
Chaim Sheba Medical Center
Ramat Gan
Magen
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv
Cohen
South Korea6 sites, 6 recruiting
- Recruiting
Chonnam National University Hwasun Hospital
Gwangju
Jung
- Recruiting
Department of Oncology, Asan Medical Center
Seoul
Yoon
- Recruiting
Samsung Medical Center
Seoul
Kim
- Recruiting
Seoul National University Hospital, Internal Medicine
Seoul
Koh
- Recruiting
Severance Hospital
Seoul
Kim
- Recruiting
St. Mary's Hospital
Seoul
Min
Belgium5 sites, 5 recruiting
- Recruiting
Jessa Ziekenhuis
Hasselt
Theunissen
- Recruiting
Department of Hematology, CH Jolimont
La Louvière
Kentos
- Recruiting
University Hospital Leuven
Leuven
Delforge
- Recruiting
Centre hospitalier universitaire de Liege
Liège
Caers
- Recruiting
Algemeen Ziekenhuis Delta
Roeselare
Deleu
Czechia5 sites, 5 recruiting
- Recruiting
Fakultni Nemocnice Hradec Kralove
Hradec Králové
Radocha
- Recruiting
University Hospital Olomouc
Olomouc
Minarik
- Recruiting
Fakultni Nemocnice Ostrava
Ostrava
Hajek
- Recruiting
Fakultni Nemocnice Plzen
Pilsen
Jungova
- Recruiting
Vseobecna Fakultni Nemocnice V Praze
Prague
Spicka
Denmark4 sites, 4 recruiting
- Recruiting
Aarhus Universitetshospital
Aarhus
Ølholm Vase
- Recruiting
Rigshospitalet
Copenhagen
Szabo
- Recruiting
Odense University Hospital
Odense
Krejcik
- Recruiting
Lillebaelt Hospital
Vejle
Farmer
Greece4 sites, 4 recruiting
- Recruiting
University General Hospital Of Alexandroupoli
Alexandroupoli
Spanoudakis
- Recruiting
Evaggelismos Hospital
Athens
Delimpasi
- Recruiting
Regional General Hospital Alexandra
Athens
Terpos
- Recruiting
Theageneio Cancer Hospital
Thessaloniki
Katodrytou
Serbia4 sites, 4 recruiting
- Recruiting
University Clinical Center of Serbia
Belgrade
Bila
- Recruiting
Clinical Centre of Kragujevac
Kragujevac
Djurdjevic
- Recruiting
Clinical Centre of Nis
Niš
Vucic
- Recruiting
Clinical Centre of Vojvodina
Novi Sad
Urosevic
Argentina3 sites, 3 recruiting
- Recruiting
Hospital Italiano
Buenos Aires
Fantl
- Recruiting
Hospital Privado
Córdoba
Caeiro
- Recruiting
Sanatorio Britanico Rosario
Rosario
Funes
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital Basel
Basel
Heim
- Recruiting
Inselspital
Bern
Pabst
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen
Hess-Mildenberger
United Kingdom3 sites, 3 recruiting
- Recruiting
Hammersmith Hospital - Imperial College NHS Healthcare Trust
London
Atta
- Recruiting
University College London (UCL)
London
Rabin
- Recruiting
The Royal Marsden Hospital
Sutton
Boyd
Poland2 sites, 2 recruiting
- Recruiting
Department of Hematology and Transplantology University Clinical Center
Gdansk
Tyczynska
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan
Dytfeld
About this study
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
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.
- Conditions
- Multiple Myeloma
- Being tested
- Teclistamab, Lenalidomide
- Keywords
- Maintenance, Teclistamab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Also called JNJ-64007957
Teclistamab will be administered via a subcutaneous injection (SC)
LenalidomideDrug
Lenalidomide will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Teclistamab-Lenalidomide (Tec-Len) | Experimental | Teclistamab will be administered via a subcutaneous injection (SC) Receives: Drug: Teclistamab; Drug: Lenalidomide |
| Arm B Lenalidomide Alone (Len) | Active comparator | Lenalidomide orally. Receives: Drug: Lenalidomide |
| Arm C Teclistamab-Alone (Tec) | Experimental | Teclistamab will be administered via a subcutaneous injection (SC) Receives: Drug: Teclistamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at month 12
Secondary outcomes (7)
Comparison of efficacy
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
Measured: from randomization to the date of disease progression or death (approximately up to 8 years)
Overall Survival (OS)
Overall Survival (OS), measured from the date of from randomization to the date the subject's death
Measured: 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
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.
Measured: baseline up to 8 years
EQ-5D-5L health utility values and the difference between-treatment arms
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"
Measured: baseline up to 8 years
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms
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.
Measured: baseline up to 8 years
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms
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
Measured: baseline up to week 24
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms
PGIS is a 1 item questionnaire that evaluates patients' health and assesses if there has been an improvement or decline in clinical status
Measured: baseline up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start8 Sep 2022
- Primary completionApr 2028 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Myeloma Network B.V.
- Sponsor type
- Research network
- Collaborators
- Janssen Pharmaceutica
- Responsible party
- Sponsor
- Investigators
- Niels van de Donk, Professor, Principal investigator, Amsterdam UMC, Vrije Universiteit AmsterdamElena Zamagni, Professor, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243797
- Sponsor's protocol ID
- EMN30/64007957MMY3003
- Acronym
- MajesTEC-4
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05243797
- Acronym / sponsor ID
- MajesTEC-4 / EMN30/64007957MMY3003
- Conditions
- Multiple Myeloma
- Keywords
- Maintenance, Teclistamab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,594 participants (estimated)
- Lead sponsor
- European Myeloma Network B.V.Research network
- Collaborators
- Janssen Pharmaceutica
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Teclistamab-Lenalidomide (Tec-Len) | Experimental | Drug: Teclistamab, Drug: LenalidomideTeclistamab will be administered via a subcutaneous injection (SC) |
| Arm B Lenalidomide Alone (Len) | Active comparator | Drug: LenalidomideLenalidomide orally. |
| Arm C Teclistamab-Alone (Tec) | Experimental | Drug: TeclistamabTeclistamab will be administered via a subcutaneous injection (SC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabAlso: JNJ-64007957Teclistamab will be administered via a subcutaneous injection (SC) | Drug | Arm A: Teclistamab-Lenalidomide (Tec-Len), Arm C Teclistamab-Alone (Tec) |
| LenalidomideLenalidomide will be administered orally | Drug | Arm A: Teclistamab-Lenalidomide (Tec-Len), Arm B Lenalidomide Alone (Len) |
Primary outcome
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.
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.
7 secondary outcomes
Comparison of efficacy
Time frame: from randomization to the date of disease progression or death (approximately up to 8 years)
Overall Survival (OS)
Time frame: 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
EQ-5D-5L health utility values and the difference between-treatment arms
Time frame: 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
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niels van de Donk, Professor principal investigator
Amsterdam UMC, Vrije Universiteit Amsterdam
Elena Zamagni, Professor principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"
212 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teclistamab and Lenalidomide in people with Multiple Myeloma, run by European Myeloma Network B.V. at 212 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 212 sites in United States, Italy, Brazil, China, Australia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Witty (+31 10 268 70 65, Christine.Witty@emn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: from randomization to the date of disease progression or death (approximately up to 8 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.