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
- Registration Number
- NCT05243797
- Lead Sponsor
- Stichting European Myeloma Network
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1594
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Teclistamab-Lenalidomide (Tec-Len) Teclistamab Teclistamab will be administered via a subcutaneous injection (SC) Arm A: Teclistamab-Lenalidomide (Tec-Len) Lenalidomide Teclistamab will be administered via a subcutaneous injection (SC) Arm C Teclistamab-Alone (Tec) Teclistamab Teclistamab will be administered via a subcutaneous injection (SC) Arm B Lenalidomide Alone (Len) Lenalidomide Lenalidomide orally.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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) 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.
- Secondary Outcome Measures
Name Time Method MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms 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.
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms 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
Overall Survival (OS) 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
EQ-5D-5L health utility values and the difference between-treatment arms 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"
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms 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
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 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.
Comparison of efficacy 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
Trial Locations
- Locations (208)
LKH Hochsteiermark
🇦🇹Vienna, Austria
The University of Arizona Cancer Center
🇺🇸Phoenix, Arizona, United States
University of California-Davis Cancer Center
🇺🇸Sacramento, California, United States
University of California, San Diego (UCSD) Medical Center
🇺🇸San Diego, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Christiana Care
🇺🇸Newark, Delaware, United States
Blood & Marrow Transplant Center, Florida Hospital Medical Group
🇺🇸Orlando, Florida, United States
Moffitt at Memorial Healthcare System
🇺🇸Tampa, Florida, United States
University of Illinois Medical Center at Chicago
🇺🇸Chicago, Illinois, United States
Greenebaum Cancer Center UM of MD
🇺🇸Baltimore, Maryland, United States
John Hopkins
🇺🇸Baltimore, Maryland, United States
Clinic Ottakring
🇦🇹Vienna, Austria
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Montefiore Medical Cente
🇺🇸Bronx, New York, United States
Mount Sinai Medical Center - 2
🇺🇸New York, New York, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care Clinical Trials
🇺🇸Cincinnati, Ohio, United States
Seidman Cancer Center-University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Ohio State Medical Center, James Cancer Center
🇺🇸Columbus, Ohio, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Abramson Cancer Center University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Gibbs Cancer Center
🇺🇸Spartanburg, South Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Renovatio Clinical Research
🇺🇸The Woodlands, Texas, United States
Baylor College of Medicine Center for Cell and Gene Therapy
🇺🇸Houston, Texas, United States
LDS Hospital/ Intermountain Healthcare
🇺🇸Salt Lake City, Utah, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
St Vincent HSHS (Green Bay Oncology)
🇺🇸Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
Sunshine Coast Health
🇦🇺Sunshine Coast, 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
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
Medical University Of Vienna
🇦🇹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
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
North China University of Science and Technology Affiliated Hospital.Hematology Department
🇨🇳Hebei, China
Shenyang City, Liaoning Province, Hematology department
🇨🇳Shenyang, China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
🇨🇳Tianjin, China
Henan Cancer Hospital
🇨🇳Henan, China
Shandong Qilu Hospital
🇨🇳Shandong, China
Shanghai Fourth People's Hospital
🇨🇳Shanghai, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
Tongji Hospital, Tongji Medical College of Hust
🇨🇳Wuhan, China
Fakultni Nemocnice Hradec Kralove
🇨🇿Hradec Králové, Czechia
Fakultni Nemocnice Ostrava
🇨🇿Ostrava, Czechia
The First Affiliated Hospital, Zhejiang University College of Medicine
🇨🇳Zhejiang, China
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Fakultni Nemocnice Plzen
🇨🇿Plzen, Czechia
Vseobecna Fakultni Nemocnice V Praze
🇨🇿Praha, 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 Nantes
🇫🇷Nantes, 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
🇩🇪Nürnberg, Germany
Centre Hospitalier Universitaire De Montpellier
🇫🇷Montpellier, France
Hopital Saint Louis
🇫🇷Paris, France
Hôpital Saint-Antoine
🇫🇷Paris, France
Centre Hospitalier Universitaire De Poitiers
🇫🇷Poitiers, France
Universitaetsklinikum Tuebingen AöR
🇩🇪Tübingen, Germany
University Hospital of Würzburg
🇩🇪Würzburg, Germany
University General Hospital Of Alexandroupoli
🇬🇷Alexandroupolis, Greece
Evaggelismos Hospital
🇬🇷Athens, Greece
Regional General Hospital Alexandra
🇬🇷Athens, Greece
Theageneio Cancer Hospital
🇬🇷Thessaloníki, 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
🇮🇱Be'er Sheva, 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
🇮🇹Firenze, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
IRCCS Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria Di Modena
🇮🇹Modena, Italy
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
🇮🇹Napoli, Italy
UOC Oncoematologia, Ospedale Policlinico Federico II
🇮🇹Napoli, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita
🇮🇹Novara, Italy
UOC Ematologia - Azienda Ospedale - Università Padova Ospedale Giustinianeo
🇮🇹Padova, 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, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
🇮🇹Trieste, Italy
Azienda Sanitaria Universitaria Friuli Centrale
🇮🇹Udine, Italy
Chonnam National University Hwasun Hospital
🇰🇷Gwangju, Korea, Republic of
Department of Oncology, Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital, Internal Medicine
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
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
Oslo University Hospital
🇳🇴Oslo, Norway
St. Olavs hospital HF
🇳🇴Trondheim, Norway
Department of Hematology and Transplantology University Clinical Center
🇵🇱Gdańsk, Poland
SPZOZ MSWiA w Poznaniu im. Prof. Ludwika Bierkowskiego, Poznań
🇵🇱Poznań, Poland
Uniwersytecki Szpital Kliniczny
🇵🇱Wrocław, Poland
CCAB Centro Clinico Academico Braga Associacao
🇵🇹Braga, Portugal
Kantonsspital St. Gallen
🇨🇭Saint Gallen, Switzerland
Champalimaud Clinical Centre
🇵🇹Lisboa, Portugal
Sao Joao University Hospital Center
🇵🇹Porto, Portugal
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
🇵🇹Lisboa, Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
🇵🇹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
University Hospital Basel
🇨🇭Basel, Switzerland
Inselspital
🇨🇭Bern, Switzerland
Ankara Liv Hospital
🇹🇷Ankara, Turkey
Ankara University Hospital
🇹🇷Ankara, Turkey
Florence Nightingale Hospital
🇹🇷Istanbul, Turkey
Medipol Mega University Hospital
🇹🇷Istanbul, Turkey
Ege University Medical faculty Hospital Internal Medicine Department Adult Hematology Unit
🇹🇷İzmir, Turkey
Izmir Economy University, Medical Point Hospital
🇹🇷İzmir, Turkey
Erciyes University Hospital
🇹🇷Kayseri, Turkey
Hammersmith Hospital - Imperial College NHS Healthcare Trust
🇬🇧London, United Kingdom
University College London (UCL)
🇬🇧London, United Kingdom
The Royal Marsden Hospital
🇬🇧Sutton, United Kingdom