Clinical trial NCT05243797: Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
Official title: Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Maintenance
Teclistamab
Lead sponsor: European Myeloma Network B.V.
Sponsor class: NETWORK
Collaborators: name: Janssen Pharmaceutica
First posted: 2022-02-17
Enrollment: 1594
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: from randomization to the date of disease progression or death (approximately up to 8 years)
measure: Minimal Residual Disease (MRD)-negative Complete Response (CR)
timeFrame: at month 12
Secondary outcomes:
measure: Comparison of efficacy
timeFrame: from randomization to the date of disease progression or death (approximately up to 8 years)
measure: Overall Survival (OS)
timeFrame: from the date of from randomization to the date the subject's death, assessed up to 8 years]
measure: 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
timeFrame: baseline up to 8 years
measure: EQ-5D-5L health utility values and the difference between-treatment arms
timeFrame: baseline up to 8 years
measure: MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms
timeFrame: baseline up to 8 years
measure: PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms
timeFrame: baseline up to week 24
measure: PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms
timeFrame: baseline up to 8 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Sacramento
country: United States
facility: University of California-Davis Cancer Center
state: California
city: San Diego
country: United States
facility: University of California, San Diego (UCSD) Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Orlando
country: United States
facility: Blood & Marrow Transplant Center, Florida Hospital Medical Group
state: Florida
city: Tampa
country: United States
facility: Moffitt at Memorial Healthcare System
state: Florida
city: Chicago
country: United States
facility: University of Illinois Medical Center at Chicago
state: Illinois
city: Baltimore
country: United States
facility: Greenebaum Cancer Center UM of MD
state: Maryland
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Cente
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center - 2
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care Clinical Trials
state: Ohio
city: Cleveland
country: United States
facility: Seidman Cancer Center-University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State Medical Center, James Cancer Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center University of Pennsylvania Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Spartanburg
country: United States
facility: Gibbs Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: El Paso
country: United States
facility: Renovatio Clinical Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Center for Cell and Gene Therapy
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital/ Intermountain Healthcare
state: Utah
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Green Bay
country: United States
facility: St Vincent HSHS (Green Bay Oncology)
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Birtinya
country: Australia
facility: Sunshine Coast Health
state: Queensland
city: Adelaide
country: Australia
facility: Flinders Medical Centre
city: Douglas
country: Australia
facility: Townsville University Hospital
city: Geelong
country: Australia
facility: Barwon Health University Hospital Geelong Andrew Love Cancer Centre
city: Melbourne
country: Australia
facility: Alfred Hospital
city: Melbourne
country: Australia
facility: Austin Health
city: Newcastle
country: Australia
facility: Calvary Mater Hospital
city: Sunshine Coast
country: Australia
facility: Sunshine Coast Health
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital
city: Sydney
country: Australia
facility: Royal North Shore Hospital
city: Feldkirch
country: Austria
facility: Landeskrankenhaus, Feldkirch
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Krems
country: Austria
facility: University Hospital Krems/Donau
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Med Campus III
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Vienna
country: Austria
facility: Clinic Ottakring
city: Vienna
country: Austria
facility: LKH Hochsteiermark
city: Vienna
country: Austria
facility: Medical University Of Vienna
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: La Louvière
country: Belgium
facility: Department of Hematology, CH Jolimont
city: Leuven
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Liège
country: Belgium
facility: Centre hospitalier universitaire de Liege
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus - Centro Integrado de Oncologia
city: Porto Alegre
country: Brazil
facility: Hospital Santa Rita
city: Rio de Janeiro
country: Brazil
facility: Instituto Americas de Ensino,Pesquisa e Inovação
city: Salvador
country: Brazil
facility: IDOR- Instituto D'or de pesquisa. Av. São Rafael
city: São Paulo
country: Brazil
facility: A Real e Benemérita Associação Portuguesa de Beneficência
city: São Paulo
country: Brazil
facility: Clínica Medica São Germano,Grupo Oncoclínicas Pesquisa Clínica
city: São Paulo
country: Brazil
facility: Departamento de Oncologia Clínica AC Camargo Cancer Center
city: São Paulo
country: Brazil
facility: Grupo Oncoclínicas Pesquisa Clínica
city: São Paulo
country: Brazil
facility: Hemocentro UNICAMP, Universidade Estadual de Campinas
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Universidade de São Paulo
city: São Paulo
country: Brazil
facility: Hospital Paulistano, Centro de Pesquisa Clinica R. Martiniano de Carvalho
city: São Paulo
country: Brazil
facility: Onco Star
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo - Hospital São Paulo
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
city: Ottawa
country: Canada
facility: The Ottawa General Hospital
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center
city: Sherbrooke
country: Canada
facility: "Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)"
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
city: Vancouver
country: Canada
facility: BC Cancer
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Hebei
country: China
facility: North China University of Science and Technology Affiliated Hospital.Hematology Department
city: Henan
country: China
facility: Henan Cancer Hospital
city: Shandong
country: China
facility: Shandong Qilu Hospital
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital
city: Shenyang
country: China
facility: Shenyang City, Liaoning Province, Hematology department
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
city: Tianjin
country: China
facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Hust
city: Zhejiang
country: China
facility: The First Affiliated Hospital, Zhejiang University College of Medicine
city: Hradec Králové
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Plzen
country: Czechia
facility: Fakultni Nemocnice Plzen
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice V Praze
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Lillebaelt Hospital
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire De Bordeaux
city: Lille
country: France
facility: Department of Hematology, CHU Lille
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire De Montpellier
city: Nantes
country: France
facility: Centre Hospitalier Universitaire De Nantes
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire De Poitiers
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire De Toulouse
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg AöR
city: Jena
country: Germany
facility: Universitaetsklinikum Jena KöR
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein AöR
city: München
country: Germany
facility: Klinikum rechts der Isar der TU Muenchen AöR
city: Nürnberg
country: Germany
facility: Klinikum Nuernberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen AöR
city: Würzburg
country: Germany
facility: University Hospital of Würzburg
city: Alexandroupolis
country: Greece
facility: University General Hospital Of Alexandroupoli
city: Athens
country: Greece
facility: Evaggelismos Hospital
city: Athens
country: Greece
facility: Regional General Hospital Alexandra
city: Thessaloníki
country: Greece
facility: Theageneio Cancer Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Be'er Sheva
country: Israel
facility: The Barzilai Medical Center
city: Haifa
country: Israel
facility: Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah tikva
country: Israel
facility: Beilinson Hospital
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Alessandria
country: Italy
facility: Azienda Sanitaria Locale Al Di Alessandria
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
city: Bari
country: Italy
facility: AOU G. Baccelli
city: Bari
country: Italy
facility: Policlinico di Bari
city: Bergamo
country: Italy
facility: A.O. Papa Giovanni XXIII
city: Bologna
country: Italy
facility: A.O.U. di Bologna - Policlinico S. Orsola Malpighi
city: Brescia
country: Italy
facility: A.O.Spedali Civili di Brescia
city: Cagliari
country: Italy
facility: Ospedale Oncologico 'A. Businco'
city: Cosenza
country: Italy
facility: Azienda Ospedaliera-Universitaria Di Cosenza
city: Firenze
country: Italy
facility: Careggi University Hospital
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: IRCCS Ospedale Maggiore Policlinico
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
city: Napoli
country: Italy
facility: UOC Oncoematologia, Ospedale Policlinico Federico II
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria Maggiore Della Carita
city: Padova
country: Italy
facility: UOC Ematologia - Azienda Ospedale - Università Padova Ospedale Giustinianeo
city: Parma
country: Italy
facility: Department of Hematology and Bone Marrow Transplant Centre, Azienda Ospedaliero - Universitaria di Parma
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pescara
country: Italy
facility: Azienda Sanitaria Locale Di Pescara
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Reggio
country: Italy
facility: Azienda USL IRCCS Di Reggio Emilia
city: Rimini
country: Italy
facility: Ospedale "Infermi" di Rimini
city: Roma
country: Italy
facility: Ematologia, Azienda Policlinico Umberto I
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo Della Sofferenza
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Oncology, Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: St. Mary's Hospital
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep Stichting
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center Rotterdam
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Trondheim
country: Norway
facility: St. Olavs hospital HF
city: Gdańsk
country: Poland
facility: Department of Hematology and Transplantology University Clinical Center
city: Poznań
country: Poland
facility: SPZOZ MSWiA w Poznaniu im. Prof. Ludwika Bierkowskiego, Poznań
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny
city: Braga
country: Portugal
facility: CCAB Centro Clinico Academico Braga Associacao
city: Lisboa
country: Portugal
facility: Champalimaud Clinical Centre
city: Lisboa
country: Portugal
facility: Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
city: Porto
country: Portugal
facility: Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
city: Porto
country: Portugal
facility: Sao Joao University Hospital Center
city: Porto
country: Portugal
facility: Unidade Local De Saude De Gaia/Espinho E.P.E.
city: Vila Real
country: Portugal
facility: Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Kragujevac
country: Serbia
facility: Clinical Centre of Kragujevac
city: Niš
country: Serbia
facility: Clinical Centre of Nis
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Ankara
country: Turkey
facility: Ankara Liv Hospital
city: Ankara
country: Turkey
facility: Ankara University Hospital
city: Istanbul
country: Turkey
facility: Florence Nightingale Hospital
city: Istanbul
country: Turkey
facility: Medipol Mega University Hospital
city: İzmir
country: Turkey
facility: Ege University Medical faculty Hospital Internal Medicine Department Adult Hematology Unit
city: İzmir
country: Turkey
facility: Izmir Economy University, Medical Point Hospital
city: Kayseri
country: Turkey
facility: Erciyes University Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital - Imperial College NHS Healthcare Trust
city: London
country: United Kingdom
facility: University College London (UCL)
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
affiliation: Amsterdam UMC, Vrije Universiteit Amsterdam
name: Niels van de Donk, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"
name: Elena Zamagni, Professor
role: PRINCIPAL_INVESTIGATOR
References: