Clinical trial • Phase III • Haematology
TECLISTAMAB for Multiple myeloma
Phase III trial of TECLISTAMAB for Multiple myeloma.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody|Monoclonal antibody|Small molecule|Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 27-06-2024
- First CTIS Authorization Date
- 26-08-2024
Trial design
Randomised, daratumumab subcutaneous + lenalidomide + dexamethasone (drd); specific doses and schedule not specified in the ctis summary-controlled Phase III trial in Italy, Austria, Netherlands and others.
- Randomised
- Yes
- Comparator
- Daratumumab subcutaneous + Lenalidomide + Dexamethasone (DRd); specific doses and schedule not specified in the CTIS summary
- Target Sample Size
- 937
Eligibility
Recruits 937 adults.
- Pregnancy Exclusion
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
Inclusion criteria
- {"criterion_text":"- Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria\n- Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment\n- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2\n- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment\n- A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment"}
Exclusion criteria
- {"criterion_text":"- Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (≥)20 mg of dexamethasone within 14 days before Randomization.\n- Had plasmapheresis within 28 days of randomization\n- Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization\n- Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients\n- Known contraindications to the use of daratumumab or lenalidomide per local prescribing information\n- Myeloma Frailty Index of ≥2 with the exception of participants who have a score of 2 based on age alone"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Dual primary endpoints: PFS; 12-month MRD-negative CR","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 937
- Recruitment Window Months
- 129
- Consent Approach
- Informed consent documents (subject information and informed consent forms) are provided as country-specific ICFs. Multiple country/language versions are available (examples seen in CTIS documents: English, Italian, German, Dutch, Polish, Norwegian, Swedish, French, Czech, Spanish, Portuguese). ICFs and related documents (withdrawal forms, pregnant partner/patient information, subject wallet cards) are provided by the sponsor per country. No specific pediatric assent forms are listed in the public CTIS documents.
Geography
- Total Number Of Sites
- 90
- Total Number Of Participants
- 568
Italy
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 02-09-2024
- Processing Time Days
- 48
- Number Of Sites
- 9
- Number Of Participants
- 50
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- UOC Ematologia - Building 2, 3° piano
- Principal Investigator Name
- Rita Mazza
- Principal Investigator Email
- rita.mazza@cancercenter.humanitas.it
- Contact Person Name
- Rita Mazza
- Contact Person Email
- rita.mazza@cancercenter.humanitas.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- UOC Ematologia
- Principal Investigator Name
- Alessandra Larocca
- Principal Investigator Email
- alessandra.larocca@unito.it
- Contact Person Name
- Alessandra Larocca
- Contact Person Email
- alessandra.larocca@unito.it
- Site Name
- Careggi University Hospital
- Department Name
- SOD Ematologia
- Principal Investigator Name
- Elisabetta Antonioli
- Principal Investigator Email
- antoniolie@aou-careggi.toscana.it
- Contact Person Name
- Elisabetta Antonioli
- Contact Person Email
- antoniolie@aou-careggi.toscana.it
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- UO Ematologia con TMO
- Principal Investigator Name
- Salvatore Palmieri
- Principal Investigator Email
- salvatore.palmieri@aocardarelli.it
- Contact Person Name
- Salvatore Palmieri
- Contact Person Email
- salvatore.palmieri@aocardarelli.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Dipartimento Malattie Oncologiche ed Ematologiche
- Principal Investigator Name
- Elena Zamagni
- Principal Investigator Email
- e.zamagni@unibo.it
- Contact Person Name
- Elena Zamagni
- Contact Person Email
- e.zamagni@unibo.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- SC Ematologia 1
- Principal Investigator Name
- Silvia Mangiacavalli
- Principal Investigator Email
- silvia_mangiacavalli@hotmail.com
- Contact Person Name
- Silvia Mangiacavalli
- Contact Person Email
- silvia_mangiacavalli@hotmail.com
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- UOC Patologie Linfoproliferatve
- Principal Investigator Name
- Luca Franceschini
- Principal Investigator Email
- luca.franceschini@ptvonline.it
- Contact Person Name
- Luca Franceschini
- Contact Person Email
- luca.franceschini@ptvonline.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UO Ematologia - TMO
- Principal Investigator Name
- Valeria Ferla
- Principal Investigator Email
- FERLA.VALERIA@hsr.it
- Contact Person Name
- Valeria Ferla
- Contact Person Email
- FERLA.VALERIA@hsr.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- UOC Ematologia
- Principal Investigator Name
- Monica Galli
- Principal Investigator Email
- monicagalli@asst-pg23.it
- Contact Person Name
- Monica Galli
- Contact Person Email
- monicagalli@asst-pg23.it
Austria
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 02-09-2024
- Processing Time Days
- 48
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- 3rd Med. Depart. Hematology, Med. Oncology, Hemostaseology, Infectious Disease and Rheumatology
- Principal Investigator Name
- Thomas Melchardt
- Principal Investigator Email
- t.melchardt@salk.at
- Contact Person Name
- Thomas Melchardt
- Contact Person Email
- t.melchardt@salk.at
- Site Name
- Medical University Of Vienna
- Department Name
- Univ. clinic for Internal Medicine I, Department of hematology und hemostaseology
- Principal Investigator Name
- Maria-Theresia Krauth
- Principal Investigator Email
- maria.krauth@meduniwien.ac.at
- Contact Person Name
- Maria-Theresia Krauth
- Contact Person Email
- maria.krauth@meduniwien.ac.at
- Site Name
- Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
- Department Name
- 3. Medical department – Department of hematology & Oncology
- Principal Investigator Name
- Agnes List
- Principal Investigator Email
- agnes.list@oegk.at
- Contact Person Name
- Agnes List
- Contact Person Email
- agnes.list@oegk.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Internal 1 - Hematology with stem cell transplantation, hemostaseology and medical oncology
- Principal Investigator Name
- Irene Strassl
- Principal Investigator Email
- irene.strassl@ordensklinikum.at
- Contact Person Name
- Irene Strassl
- Contact Person Email
- irene.strassl@ordensklinikum.at
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 42
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- Hematologie
- Principal Investigator Name
- Inger Nijhof
- Principal Investigator Email
- i.nijhof@antoniusziekenhuis.nl
- Contact Person Name
- Inger Nijhof
- Contact Person Email
- i.nijhof@antoniusziekenhuis.nl
- Site Name
- Reinier de Graaf Groep
- Department Name
- Hematologie
- Principal Investigator Name
- Savita Soechit
- Principal Investigator Email
- s.soechit@rdgg.nl
- Contact Person Name
- Savita Soechit
- Contact Person Email
- s.soechit@rdgg.nl
- Site Name
- Gelre Hospitals
- Department Name
- Hematologie
- Principal Investigator Name
- Cees Schaar
- Principal Investigator Email
- c.schaar@gelre.nl
- Contact Person Name
- Cees Schaar
- Contact Person Email
- c.schaar@gelre.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Hematologie
- Principal Investigator Name
- Niels van de Donk
- Principal Investigator Email
- n.vandedonk@amsterdamumc.nl
- Contact Person Name
- Niels van de Donk
- Contact Person Email
- n.vandedonk@amsterdamumc.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Hematologie
- Principal Investigator Name
- Roel Van Kampen
- Principal Investigator Email
- r.vankampen@zuyderland.nl
- Contact Person Name
- Roel Van Kampen
- Contact Person Email
- r.vankampen@zuyderland.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 29-08-2024
- Processing Time Days
- 44
- Number Of Sites
- 9
- Number Of Participants
- 80
Sites
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Hematologii
- Principal Investigator Name
- Marta Sobas
- Principal Investigator Email
- marta.sobas@biziel.pl
- Contact Person Name
- Marta Sobas
- Contact Person Email
- marta.sobas@biziel.pl
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Klinika Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Pawel Steckiewicz
- Principal Investigator Email
- p.steckiewicz@gmail.com
- Contact Person Name
- Pawel Steckiewicz
- Contact Person Email
- p.steckiewicz@gmail.com
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Principal Investigator Name
- Wojciech Legiec
- Principal Investigator Email
- legiec.wojciech@gmail.com
- Contact Person Name
- Wojciech Legiec
- Contact Person Email
- legiec.wojciech@gmail.com
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddzial Hematologii z Pododdzialem Chemioterapii - Klinika Hematologii
- Principal Investigator Name
- Joanna Gora-Tybor
- Principal Investigator Email
- joannagora@op.pl
- Contact Person Name
- Joanna Gora-Tybor
- Contact Person Email
- joannagora@op.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Katedra i Klinika Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Marek Hus
- Principal Investigator Email
- markhus@o2.pl
- Contact Person Name
- Marek Hus
- Contact Person Email
- markhus@o2.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddzial Hematologii I Transplantacji Szpiku
- Principal Investigator Name
- Dominik Dytfeld
- Principal Investigator Email
- dytfeld@me.com
- Contact Person Name
- Dominik Dytfeld
- Contact Person Email
- dytfeld@me.com
- Site Name
- Pratia Hematologia Sp. z o.o.
- Department Name
- Pratia Onkologia Katowice
- Principal Investigator Name
- Sebastian Grosicki
- Principal Investigator Email
- sgrosicki@wp.pl
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- sgrosicki@wp.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Katedra I Klinika Hematologii, Transplantologii I Chorob Wewnetrznych
- Principal Investigator Name
- Krzysztof Jamroziak
- Principal Investigator Email
- k.m.jamroziak@gmail.com
- Contact Person Name
- Krzysztof Jamroziak
- Contact Person Email
- k.m.jamroziak@gmail.com
- Site Name
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Principal Investigator Name
- Jacek Krzanowski
- Principal Investigator Email
- jacek.krzanowski@gmail.com
- Contact Person Name
- Jacek Krzanowski
- Contact Person Email
- jacek.krzanowski@gmail.com
Norway
- Earliest CTIS Part Ii Submission Date
- 31-07-2024
- Latest Decision Or Authorization Date
- 26-08-2024
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- OMC
- Principal Investigator Name
- Fredrik Shjesvold
- Principal Investigator Email
- fredrikschjesvold@gmail.com
- Contact Person Name
- Fredrik Shjesvold
- Contact Person Email
- fredrikschjesvold@gmail.com
- Site Name
- St. Olavs Hospital HF
- Department Name
- Of hematology
- Principal Investigator Name
- Tobias S. Slørdahl
- Principal Investigator Email
- tobias.s.slordahl@ntnu.no
- Contact Person Name
- Tobias S. Slørdahl
- Contact Person Email
- tobias.s.slordahl@ntnu.no
Sweden
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 29-08-2024
- Processing Time Days
- 44
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Region Oerebro Laen
- Department Name
- Medicinmottagning 2
- Principal Investigator Name
- Jacob Crafoord
- Principal Investigator Email
- jacob.crafoord@regionorebrolan.se
- Contact Person Name
- Jacob Crafoord
- Contact Person Email
- jacob.crafoord@regionorebrolan.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematologimottagning
- Principal Investigator Name
- Konstantinos Lemonakis
- Principal Investigator Email
- konstantinos.lemonakis@skane.se
- Contact Person Name
- Konstantinos Lemonakis
- Contact Person Email
- konstantinos.lemonakis@skane.se
- Site Name
- Karolinska University Hospital
- Department Name
- Hematologiskt centrum
- Principal Investigator Name
- Katarina Uttervall
- Principal Investigator Email
- katarina.uttervall@regionstockholm.se
- Contact Person Name
- Katarina Uttervall
- Contact Person Email
- katarina.uttervall@regionstockholm.se
- Site Name
- Region Dalarna
- Department Name
- Medicinkliniken Hematologimottagningen
- Principal Investigator Name
- Max Flogegard
- Principal Investigator Email
- max.flogegard@regiondalarna.se
- Contact Person Name
- Max Flogegard
- Contact Person Email
- max.flogegard@regiondalarna.se
Denmark
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 26-08-2024
- Processing Time Days
- 41
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Sygehus Lillebaelt Vejle Sygehus
- Department Name
- Department Of Hematology
- Principal Investigator Name
- Sarah Farmer
- Principal Investigator Email
- Sarah.Farmer1@rsyd.dk
- Contact Person Name
- Sarah Farmer
- Contact Person Email
- Sarah.Farmer1@rsyd.dk
- Site Name
- Næstved Hospital
- Department Name
- Haematologisk Administrationsgang
- Principal Investigator Name
- Trung Hieu Do
- Principal Investigator Email
- trhd@regionsjaelland.dk
- Contact Person Name
- Trung Hieu Do
- Contact Person Email
- trhd@regionsjaelland.dk
- Site Name
- Region Midtjylland
- Department Name
- Klinik for Blodsygdomme
- Principal Investigator Name
- Robert Schou Pedersen
- Principal Investigator Email
- Robert.Schou.Pedersen@goedstrup.rm.dk
- Contact Person Name
- Robert Schou Pedersen
- Contact Person Email
- Robert.Schou.Pedersen@goedstrup.rm.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Henrik Gregersen
- Principal Investigator Email
- henrik.gregersen@rn.dk
- Contact Person Name
- Henrik Gregersen
- Contact Person Email
- henrik.gregersen@rn.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 26-08-2024
- Processing Time Days
- 41
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Hemotologie
- Principal Investigator Name
- Koen Maes
- Principal Investigator Email
- koen.maes@azgroeninge.be
- Contact Person Name
- Koen Maes
- Contact Person Email
- koen.maes@azgroeninge.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematologie
- Principal Investigator Name
- Nicolas Kint
- Principal Investigator Email
- Nicolas.kint@uzgent.be
- Contact Person Name
- Nicolas Kint
- Contact Person Email
- Nicolas.kint@uzgent.be
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- Hematologie
- Principal Investigator Name
- Ka Lung Wu
- Principal Investigator Email
- kalung.wu@zas.be
- Contact Person Name
- Ka Lung Wu
- Contact Person Email
- kalung.wu@zas.be
- Site Name
- UZ Leuven
- Department Name
- Hematologie
- Principal Investigator Name
- Michel Delforge
- Principal Investigator Email
- michel.delforge@uzleuven.be
- Contact Person Name
- Michel Delforge
- Contact Person Email
- michel.delforge@uzleuven.be
- Site Name
- Institut Jules Bordet
- Department Name
- Hématologie
- Principal Investigator Name
- Nathalie Meuleman
- Principal Investigator Email
- nathalie.meuleman@hubruxelles.be
- Contact Person Name
- Nathalie Meuleman
- Contact Person Email
- nathalie.meuleman@hubruxelles.be
France
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 30-08-2024
- Processing Time Days
- 45
- Number Of Sites
- 12
- Number Of Participants
- 70
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hématologie
- Principal Investigator Name
- Aurore PERROT
- Principal Investigator Email
- perrot.aurore@iuct-oncopole.fr
- Contact Person Name
- Aurore PERROT
- Contact Person Email
- perrot.aurore@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hématologie clinique et de Thérapie cellulaire
- Principal Investigator Name
- Cyrille HULIN
- Principal Investigator Email
- cyrille.hulin@chu-bordeaux.fr
- Contact Person Name
- Cyrille HULIN
- Contact Person Email
- cyrille.hulin@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hématologie Clinique
- Principal Investigator Name
- Cyrille TOUZEAU
- Principal Investigator Email
- Cyrille.TOUZEAU@chu-nantes.fr
- Contact Person Name
- Cyrille TOUZEAU
- Contact Person Email
- Cyrille.TOUZEAU@chu-nantes.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Oncology and Hematology
- Principal Investigator Name
- Cecile SONNTAG
- Principal Investigator Email
- c.sonntag@icans.eu
- Contact Person Name
- Cecile SONNTAG
- Contact Person Email
- c.sonntag@icans.eu
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hématologie et Thérapie cellulaire
- Principal Investigator Name
- MOHAMAD MOHTY
- Principal Investigator Email
- hematosa.urcest.sat@aphp.fr
- Contact Person Name
- MOHAMAD MOHTY
- Contact Person Email
- hematosa.urcest.sat@aphp.fr
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Department Name
- Hématologie
- Principal Investigator Name
- Cecile SONNTAG
- Principal Investigator Email
- c.sonntag@icans.eu
- Contact Person Name
- Cecile SONNTAG
- Contact Person Email
- c.sonntag@icans.eu
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Hématologie Clinique
- Principal Investigator Name
- Jean-noel BASTIE
- Principal Investigator Email
- jean-noel.bastie@chu-dijon.fr
- Contact Person Name
- Jean-noel BASTIE
- Contact Person Email
- jean-noel.bastie@chu-dijon.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Hématologie Clinique
- Principal Investigator Name
- Lionel KARLIN
- Principal Investigator Email
- lionel.karlin@chu-lyon.fr
- Contact Person Name
- Lionel KARLIN
- Contact Person Email
- lionel.karlin@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Hématologie et Thérapie cellulaire
- Principal Investigator Name
- Xavier LELEU
- Principal Investigator Email
- xavier.leleu@chu-poitiers.fr
- Contact Person Name
- Xavier LELEU
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Creteil)
- Department Name
- Hémopathies Lymphoïdes
- Principal Investigator Name
- Karim BELHADJ-MERZOUG
- Principal Investigator Email
- karim.belhadj@aphp.fr
- Contact Person Name
- Karim BELHADJ-MERZOUG
- Contact Person Email
- karim.belhadj@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hématologie
- Principal Investigator Name
- Olivier DECAUX
- Principal Investigator Email
- Olivier.Decaux@chu-rennes.fr
- Contact Person Name
- Olivier DECAUX
- Contact Person Email
- Olivier.Decaux@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Hématologie
- Principal Investigator Name
- Salomon MANIER
- Principal Investigator Email
- salomon.manier@chru-lille.fr
- Contact Person Name
- Salomon MANIER
- Contact Person Email
- salomon.manier@chru-lille.fr
Greece
- Earliest CTIS Part Ii Submission Date
- 11-09-2024
- Latest Decision Or Authorization Date
- 18-10-2024
- Processing Time Days
- 37
- Number Of Sites
- 3
- Number Of Participants
- 23
Sites
- Site Name
- Theageneio Cancer Hospital
- Department Name
- Hematology Clinic
- Principal Investigator Name
- Eirini Katodritou
- Principal Investigator Email
- eirinikatodritou@gmail.com
- Contact Person Name
- Eirini Katodritou
- Contact Person Email
- eirinikatodritou@gmail.com
- Site Name
- Alexandra Hospital
- Department Name
- Therapeutic Clinic-Oncology Department
- Principal Investigator Name
- Meletios-Athanasios Dimopoulos
- Principal Investigator Email
- mdimop@med.uoa.gr
- Contact Person Name
- Meletios-Athanasios Dimopoulos
- Contact Person Email
- mdimop@med.uoa.gr
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- Hematology Department and Bone Marrow Transplantation Unit
- Principal Investigator Name
- Michail Iskas
- Principal Investigator Email
- michail.iskas@gpapanikolaou.gr
- Contact Person Name
- Michail Iskas
- Contact Person Email
- michail.iskas@gpapanikolaou.gr
Germany
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 28-08-2024
- Processing Time Days
- 43
- Number Of Sites
- 8
- Number Of Participants
- 46
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Hämatologie und Stammzelltransplantation
- Principal Investigator Name
- Amelie Boquoi
- Principal Investigator Email
- amelie.boquoi@uk-essen.de
- Contact Person Name
- Amelie Boquoi
- Contact Person Email
- amelie.boquoi@uk-essen.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Klinik fuer Innere Medizin 5, Schwerpunkt Onkologie/Haematologie
- Principal Investigator Name
- Stefan Knop
- Principal Investigator Email
- stefan.knop@klinikum-nuernberg.de
- Contact Person Name
- Stefan Knop
- Contact Person Email
- stefan.knop@klinikum-nuernberg.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- Abt. Haematologie/Onkologie
- Principal Investigator Name
- Franziska Brunner
- Principal Investigator Email
- franziska.brunner@uk-halle.de
- Contact Person Name
- Franziska Brunner
- Contact Person Email
- franziska.brunner@uk-halle.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Med. Klinik und Poliklinik II, Abteilung fur Onkologie/Haematologie
- Principal Investigator Name
- Martin Kortuem
- Principal Investigator Email
- kortuem_m@ukw.de
- Contact Person Name
- Martin Kortuem
- Contact Person Email
- kortuem_m@ukw.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Med. Klinik und Poliklinik, Haematologie u. Onkologie
- Principal Investigator Name
- Katja Weisel
- Principal Investigator Email
- k.weisel@uke.de
- Contact Person Name
- Katja Weisel
- Contact Person Email
- k.weisel@uke.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Abteilung fur Innere Medizin II, Hamatologie, Onkologie Rheumatololgie
- Principal Investigator Name
- Britta Besemer
- Principal Investigator Email
- britta.besemer@med.uni-tuebingen.de
- Contact Person Name
- Britta Besemer
- Contact Person Email
- britta.besemer@med.uni-tuebingen.de
- Site Name
- HELIOS Klinikum Berlin-Buch GmbH
- Department Name
- Klinik Fuer Haematologie Onkologie Und Turmorimmunologie
- Principal Investigator Name
- Snjezana Janjetovic
- Principal Investigator Email
- Snjezana.Janjetovic@helios-gesundheit.de
- Contact Person Name
- Snjezana Janjetovic
- Contact Person Email
- Snjezana.Janjetovic@helios-gesundheit.de
- Site Name
- Klinikum Nuernberg (additional listed site)
- Department Name
- Klinik fuer Innere Medizin 5, Schwerpunkt Onkologie/Haematologie
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 30-08-2024
- Processing Time Days
- 45
- Number Of Sites
- 6
- Number Of Participants
- 42
Sites
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interni hematologicka a onkologicka klinika
- Principal Investigator Name
- Ludek Pour
- Principal Investigator Email
- pour.ludek@fnbrno.cz
- Contact Person Name
- Ludek Pour
- Contact Person Email
- pour.ludek@fnbrno.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Principal Investigator Name
- Roman Hajek
- Principal Investigator Email
- roman.hajek@fno.cz
- Contact Person Name
- Roman Hajek
- Contact Person Email
- roman.hajek@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. interni klinika- klinika hematologie
- Principal Investigator Name
- Ivan Spicka
- Principal Investigator Email
- spicka@cesnet.cz
- Contact Person Name
- Ivan Spicka
- Contact Person Email
- spicka@cesnet.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Hemato-onkologicka klinika
- Principal Investigator Name
- Jiri Minarik
- Principal Investigator Email
- abretina@email.cz
- Contact Person Name
- Jiri Minarik
- Contact Person Email
- abretina@email.cz
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- Hemato-onkologicke oddeleni
- Principal Investigator Name
- Alexandra Jungova
- Principal Investigator Email
- jungovaa@fnplzen.cz
- Contact Person Name
- Alexandra Jungova
- Contact Person Email
- jungovaa@fnplzen.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV.interni hematologicka klinika
- Principal Investigator Name
- Jakub Radocha
- Principal Investigator Email
- jakub.radocha@centrum.cz
- Contact Person Name
- Jakub Radocha
- Contact Person Email
- jakub.radocha@centrum.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 42
- Number Of Sites
- 14
- Number Of Participants
- 100
Sites
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematology
- Principal Investigator Name
- Carmen Martinez-Chamorro
- Principal Investigator Email
- mcarmen.chamorro@quironsalud.es
- Contact Person Name
- Carmen Martinez-Chamorro
- Contact Person Email
- mcarmen.chamorro@quironsalud.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Laura Abril Sabater
- Principal Investigator Email
- labril@iconcologia.net
- Contact Person Name
- Laura Abril Sabater
- Contact Person Email
- labril@iconcologia.net
- Site Name
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Department Name
- Hematology
- Principal Investigator Name
- Josep María Marti Tutusaus
- Principal Investigator Email
- jmarti@mutuaterrassa.es
- Contact Person Name
- Josep María Marti Tutusaus
- Contact Person Email
- jmarti@mutuaterrassa.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Hematology
- Principal Investigator Name
- Teresa De Soto Álvarez
- Principal Investigator Email
- desoto.teresa@gmail.com
- Contact Person Name
- Teresa De Soto Álvarez
- Contact Person Email
- desoto.teresa@gmail.com
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- Hematology
- Principal Investigator Name
- Sebastian Garzón López
- Principal Investigator Email
- sebastianf.garzon.sspa@juntadeandalucia.es
- Contact Person Name
- Sebastian Garzón López
- Contact Person Email
- sebastianf.garzon.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Mercedes Gironella Mesa
- Principal Investigator Email
- mgironella@vhio.net
- Contact Person Name
- Mercedes Gironella Mesa
- Contact Person Email
- mgironella@vhio.net
- Site Name
- Institut Catala D'oncologia (L'hospitalet)
- Department Name
- Hematology
- Principal Investigator Name
- Anna Sureda Balari
- Principal Investigator Email
- asureda@iconcologia.net
- Contact Person Name
- Anna Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- University Hospital Son Espases
- Department Name
- Hematology
- Principal Investigator Name
- Antonia Sampol Mayol
- Principal Investigator Email
- antonia.sampolm@ssib.es
- Contact Person Name
- Antonia Sampol Mayol
- Contact Person Email
- antonia.sampolm@ssib.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Joaquin Martinez López
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquin Martinez López
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Hematlogy
- Principal Investigator Name
- Jordi López Pardo
- Principal Investigator Email
- jlopezpar@santpau.cat
- Contact Person Name
- Jordi López Pardo
- Contact Person Email
- jlopezpar@santpau.cat
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Hematology
- Principal Investigator Name
- Esther Clavero Sanchez
- Principal Investigator Email
- eclaverosa@hotmail.com
- Contact Person Name
- Esther Clavero Sanchez
- Contact Person Email
- eclaverosa@hotmail.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Hematology
- Principal Investigator Name
- Felipe Casado Montero
- Principal Investigator Email
- lfcasado@hmhospitales.com
- Contact Person Name
- Felipe Casado Montero
- Contact Person Email
- lfcasado@hmhospitales.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology clinical trials
- Principal Investigator Name
- Maria Victoria Mateos Manteca
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- Maria Victoria Mateos Manteca
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Hematology
- Principal Investigator Name
- Ana Isabel Teruel Casasús
- Principal Investigator Email
- ateruelc@hotmail.com
- Contact Person Name
- Ana Isabel Teruel Casasús
- Contact Person Email
- ateruelc@hotmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 42
- Number Of Sites
- 5
- Number Of Participants
- 31
Sites
- Site Name
- Champalimaud Clinical Centre
- Department Name
- Unidade de Hemato-Oncologia
- Principal Investigator Name
- Paulo Lúcio
- Principal Investigator Email
- paulo.lucio@fundacaochampalimaud.pt
- Contact Person Name
- Paulo Lúcio
- Contact Person Email
- paulo.lucio@fundacaochampalimaud.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Serviço de Oncologia Médica
- Principal Investigator Name
- José Freitas
- Principal Investigator Email
- jose.p.freitas@hb.min-saude.pt
- Contact Person Name
- José Freitas
- Contact Person Email
- jose.p.freitas@hb.min-saude.pt
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Serviço de Hematologia
- Principal Investigator Name
- Sara Valle
- Principal Investigator Email
- sara.valle@ulsas.pt
- Contact Person Name
- Sara Valle
- Contact Person Email
- sara.valle@ulsas.pt
- Site Name
- University Of Porto
- Department Name
- Serviço de Hematologia Clínica
- Principal Investigator Name
- Rui Bergantim
- Principal Investigator Email
- rui.bergantim@chsj.min-saude.pt
- Contact Person Name
- Rui Bergantim
- Contact Person Email
- rui.bergantim@chsj.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Serviço de Hematologia e Transplantação de Medula Óssea
- Principal Investigator Name
- Luisa Viterbo
- Principal Investigator Email
- lviterbo@ipoporto.min-saude.pt
- Contact Person Name
- Luisa Viterbo
- Contact Person Email
- lviterbo@ipoporto.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Parexel International Co. Ltd.
- Responsibilities
- code 6
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- code 3
Third parties
- {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Taiwan","full_name":"Parexel International Co. Ltd.","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- teclistamab
- Active Substance
- TECLISTAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus 1
- Investigational Product Name
- JNJ-64407564
- Active Substance
- TALQUETAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus 1
- Orphan Designation
- Yes
- Investigational Product Name
- DARZALEX 1800 mg solution for injection
- Active Substance
- DARATUMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus 2
- Orphan Designation
- Yes
- Starting Dose
- 1800 mg (product name indicates 1800 mg formulation)
- Investigational Product Name
- Lenalidomide (various marketed hard capsules)
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus 2 (marketing authorisation present for listed products)
- Dose Levels
- 5 mg|10 mg|15 mg|25 mg (marketed capsule strengths listed)
- Investigational Product Name
- Dexamethasone (various tablets)
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus 2 (marketed products listed)
- Dose Levels
- 2 mg|4 mg|8 mg (marketed tablet strengths listed)
- Investigational Product Name
- Privigen 100 mg/ml solution for infusion
- Active Substance
- HUMAN NORMAL IMMUNOGLOBULIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus 2
- Combination Treatment
- Yes
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