Clinical trial • Phase III • Oncology
ARLOCABTAGENE AUTOLEUCEL for Relapsed or refractory multiple myeloma
Phase III trial of ARLOCABTAGENE AUTOLEUCEL for Relapsed or refractory multiple myeloma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy | Monoclonal antibody | Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 22-11-2024
- First CTIS Authorization Date
- 31-03-2025
Trial design
Randomised, open-label, daratumumab + pomalidomide + dexamethasone (dpd); carfilzomib + dexamethasone (kd) — doses and schedules not specified in the ctis record.-controlled Phase III trial in Italy, Romania, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Daratumumab + Pomalidomide + Dexamethasone (DPd); Carfilzomib + Dexamethasone (Kd) — doses and schedules not specified in the CTIS record.
- Target Sample Size
- 251
Eligibility
Recruits 251 Vulnerable population not selected; participants must be at least 18 years old. Consent is provided by adult participants. No assent or specific vulnerable-population consent procedures are described in the CTIS record..
- Vulnerable Population
- Vulnerable population not selected; participants must be at least 18 years old. Consent is provided by adult participants. No assent or specific vulnerable-population consent procedures are described in the CTIS record.
Inclusion criteria
- {"criterion_text":"- Have RRMM, have received 1-3 prior lines of therapy (LOT) for MM, and with proof that the disease got worse during or after the last treatment and have prior exposure to LEN."}
- {"criterion_text":"- Have measurable signs of MM as per the study criteria."}
- {"criterion_text":"- Be at least 18 years old and have adequate organ function and performance status as per study criteria."}
Exclusion criteria
- {"criterion_text":"- Known or history of central nervous system involvement with MM."}
- {"criterion_text":"- Solitary plasmacytomas or non-secretory MM and no other measurable signs of MM."}
- {"criterion_text":"- Need for urgent treatment due to rapidly progressing MM."}
- {"criterion_text":"- Known or history of central nervous system involvement with MM."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression free survival (PFS): The average time participants are alive without their MM getting worse after starting the study.","definition_or_measurement_approach":"Defined as the average time participants are alive without disease progression after starting the study (time to MM progression or death)."}
- {"endpoint_text":"- Minimal residual disease (MRD)-negative, complete response (CR): No signs of MM can be found in the participant’s body.","definition_or_measurement_approach":"MRD-negative complete response defined as no detectable signs of multiple myeloma; (protocol translations reference assessment at approximately 9 months ± 3 months after study start)."}
Secondary endpoints
- {"endpoint_text":"- Overall survival (OS): The average time participants are alive after starting the study.","definition_or_measurement_approach":"Defined as the average time participants are alive after starting the study (time from randomization/start to death from any cause)."}
- {"endpoint_text":"- Overall response rate (ORR): How many participants show a positive response to treatment.","definition_or_measurement_approach":"Measured as the proportion of participants achieving a predefined positive tumour response to treatment according to study response criteria."}
Recruitment
- Planned Sample Size
- 251
- Recruitment Window Months
- 86
- Consent Approach
- Informed consent is obtained from adult participants (minimum age 18). Country-specific subject information and informed consent form documents are provided (multiple country/language ICFs present in the application documents). No pediatric assent procedures or other special consent procedures are described in the record.
Geography
- Total Number Of Sites
- 67
- Total Number Of Participants
- 189
Italy
- Earliest CTIS Part Ii Submission Date
- 03-03-2025
- Latest Decision Or Authorization Date
- 24-04-2025
- Processing Time Days
- 52
- Number Of Sites
- 6
- Number Of Participants
- 21
Sites
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- SOC Clinica Ematologica
- Principal Investigator Name
- Francesca Patriarca
- Principal Investigator Email
- francesca.patriarca@asufc.sanita.fvg.it
- Contact Person Name
- Francesca Patriarca
- Contact Person Email
- francesca.patriarca@asufc.sanita.fvg.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Dipartimento Malattia 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
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Hematology and Cell Therapy
- Principal Investigator Name
- Emanuele Angelucci
- Principal Investigator Email
- emanuele.angelucci@hsanmartino.it
- Contact Person Name
- Emanuele Angelucci
- Contact Person Email
- emanuele.angelucci@hsanmartino.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Cellular therapy and transplant unit
- Principal Investigator Name
- Stefania Bramanti
- Principal Investigator Email
- stefania.bramanti@cancercenter.humanitas.it
- Contact Person Name
- Stefania Bramanti
- Contact Person Email
- stefania.bramanti@cancercenter.humanitas.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Dipartimento di Oncologia ed Emato-Oncologia
- Principal Investigator Name
- Paolo Corradini
- Principal Investigator Email
- paolo.corradini@unimi.it
- Contact Person Name
- Paolo Corradini
- Contact Person Email
- paolo.corradini@unimi.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Hematology U division/SSD Clinical Trial in Oncohematology and Multiple Myeloma
- Principal Investigator Name
- Francesca Gay
- Principal Investigator Email
- francesca.gay@unito.it
- Contact Person Name
- Francesca Gay
- Contact Person Email
- francesca.gay@unito.it
Romania
- Earliest CTIS Part Ii Submission Date
- 28-02-2025
- Latest Decision Or Authorization Date
- 07-04-2025
- Processing Time Days
- 38
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Hematology
- Principal Investigator Name
- Alina Tanase
- Principal Investigator Email
- hematologie1@icfundeni.ro
- Contact Person Name
- Alina Tanase
- Contact Person Email
- hematologie1@icfundeni.ro
- Site Name
- Spitalul Universitar De Urgenta Bucuresti
- Department Name
- Hematology
- Principal Investigator Name
- Horia Bumbea
- Principal Investigator Email
- secretariat@suub.ro
- Contact Person Name
- Horia Bumbea
- Contact Person Email
- secretariat@suub.ro
- Site Name
- Institutul Regional De Oncologie Iasi
- Department Name
- Hematology
- Principal Investigator Name
- Angela Dascalescu
- Principal Investigator Email
- onco@iroiasi.ro
- Contact Person Name
- Angela Dascalescu
- Contact Person Email
- onco@iroiasi.ro
Poland
- Earliest CTIS Part Ii Submission Date
- 27-02-2025
- Latest Decision Or Authorization Date
- 06-04-2025
- Processing Time Days
- 38
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Department Name
- Oddział Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Wojciech Legieć
- Principal Investigator Email
- wlegiec@cozl.pl
- Contact Person Name
- Wojciech Legieć
- Contact Person Email
- wlegiec@cozl.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Katedra i Klinika Hematologi i Transplantologii
- Principal Investigator Name
- Jan Zaucha
- Principal Investigator Email
- info@uck.gda.pl
- Contact Person Name
- Jan Zaucha
- Contact Person Email
- info@uck.gda.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hematologii i Transplantologii- Klinika Hematologii
- Principal Investigator Name
- Agnieszka Wierzbowska
- Principal Investigator Email
- badania.kliniczne@kopernik.lodz.pl
- Contact Person Name
- Agnieszka Wierzbowska
- Contact Person Email
- badania.kliniczne@kopernik.lodz.pl
Austria
- Earliest CTIS Part Ii Submission Date
- 21-03-2025
- Latest Decision Or Authorization Date
- 07-04-2025
- Processing Time Days
- 17
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
- Department Name
- Department of Hematology and Oncology
- Principal Investigator Name
- Felix Keil
- Principal Investigator Email
- felix.keil@oegk.at
- Contact Person Name
- Felix Keil
- Contact Person Email
- felix.keil@oegk.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Department of Hematology and 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
France
- Earliest CTIS Part Ii Submission Date
- 27-03-2025
- Latest Decision Or Authorization Date
- 07-04-2025
- Processing Time Days
- 11
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- CHU Nantes
- Department Name
- Service d'Hématologie
- 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
- CHU Henri Mondor
- Department Name
- Unité Hématopathies Lymphoïdes
- Principal Investigator Name
- Karim BELHADJ-MERZOUG
- Principal Investigator Email
- romain.gounot@aphp.fr
- Contact Person Name
- Karim BELHADJ-MERZOUG
- Contact Person Email
- romain.gounot@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service clinique d'Immuno-Hématologie
- Principal Investigator Name
- Bertrand ARNULF
- Principal Investigator Email
- bertrand.arnulf@sls.aphp.fr
- Contact Person Name
- Bertrand ARNULF
- Contact Person Email
- bertrand.arnulf@sls.aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Département d'hématologie
- 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 Lille
- Department Name
- Service des Maladies du Sang
- 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
Germany
- Earliest CTIS Part Ii Submission Date
- 16-01-2025
- Latest Decision Or Authorization Date
- 04-04-2025
- Processing Time Days
- 78
- Number Of Sites
- 11
- Number Of Participants
- 22
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Hematology and Oncology
- Principal Investigator Name
- Olaf Penack
- Principal Investigator Email
- olaf.penack@charite.de
- Contact Person Name
- Olaf Penack
- Contact Person Email
- olaf.penack@charite.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Medizinische Klinik und Poliklinik
- 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 Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Martin Kortüm
- Principal Investigator Email
- kortuem_m@ukw.de
- Contact Person Name
- Martin Kortüm
- Contact Person Email
- kortuem_m@ukw.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Hematology and Oncology
- Principal Investigator Name
- Dimitrios Mougiakakos
- Principal Investigator Email
- dimitrios.mougiakakos@med.ovgu.de
- Contact Person Name
- Dimitrios Mougiakakos
- Contact Person Email
- dimitrios.mougiakakos@med.ovgu.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
- Principal Investigator Name
- Annamaria Brioli
- Principal Investigator Email
- brioli.annamaria@mh-hannover.de
- Contact Person Name
- Annamaria Brioli
- Contact Person Email
- brioli.annamaria@mh-hannover.de
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Hematology and Oncology
- Principal Investigator Name
- Mathias Haenel
- Principal Investigator Email
- m.haenel@skc.de
- Contact Person Name
- Mathias Haenel
- Contact Person Email
- m.haenel@skc.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinik für Hämatologie, Onkologie, Rheumatologie
- Principal Investigator Name
- Marc-Steffen Raab
- Principal Investigator Email
- marc.raab@med.uni-heidelberg.de
- Contact Person Name
- Marc-Steffen Raab
- Contact Person Email
- marc.raab@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für innere Medizin II
- Principal Investigator Name
- Natalie Schub
- Principal Investigator Email
- Natalie.Schub@uksh.de
- Contact Person Name
- Natalie Schub
- Contact Person Email
- Natalie.Schub@uksh.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Medizinische Klinik 5
- 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
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Klinik und Poliklinik für Innere Medizin III
- Principal Investigator Name
- Judith Hecker
- Principal Investigator Email
- judith.hecker@mri.tum.de
- Contact Person Name
- Judith Hecker
- Contact Person Email
- judith.hecker@mri.tum.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
- Principal Investigator Name
- Vladan Vucinic
- Principal Investigator Email
- vladan.vucinic@medizin.uni-leipzig.de
- Contact Person Name
- Vladan Vucinic
- Contact Person Email
- vladan.vucinic@medizin.uni-leipzig.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 31-03-2025
- Processing Time Days
- 17
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- 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
- Cliniques Universitaires Saint-Luc
- Department Name
- Hematology
- Principal Investigator Name
- Marie-Christiane Vekemans
- Principal Investigator Email
- marie-christiane.vekemans@saintluc.uclouvain
- Contact Person Name
- Marie-Christiane Vekemans
- Contact Person Email
- marie-christiane.vekemans@saintluc.uclouvain
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Hematology
- Principal Investigator Name
- Sebastien Anguille
- Principal Investigator Email
- sebastien.anguille@uza.be
- Contact Person Name
- Sebastien Anguille
- Contact Person Email
- sebastien.anguille@uza.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Hematology
- Principal Investigator Name
- Gilles Crochet
- Principal Investigator Email
- Gilles.crochet@chuuclnamur.uclouvain.be
- Contact Person Name
- Gilles Crochet
- Contact Person Email
- Gilles.crochet@chuuclnamur.uclouvain.be
Sweden
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 24-04-2025
- Processing Time Days
- 49
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Department of Hematology Bruna Stråket 5 413 45 Göteborg
- Principal Investigator Name
- Markus Hansson
- Principal Investigator Email
- markus.hansson.2@gu.se
- Contact Person Name
- Markus Hansson
- Contact Person Email
- markus.hansson.2@gu.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- VO Hematologi, Onkologi & Strålningsfysik
- Principal Investigator Name
- Stina Wichert
- Principal Investigator Email
- stina.wichert@skane.se
- Contact Person Name
- Stina Wichert
- Contact Person Email
- stina.wichert@skane.se
- Site Name
- Karolinska University Hospital
- Department Name
- ME CAST (Medicinska enheten för Cellterapi och Allogen StamcellsTransplantation)
- Principal Investigator Name
- Johan Torlen
- Principal Investigator Email
- johan.karlsson-torlen@regionstockholm.se
- Contact Person Name
- Johan Torlen
- Contact Person Email
- johan.karlsson-torlen@regionstockholm.se
Norway
- Earliest CTIS Part Ii Submission Date
- 04-03-2025
- Latest Decision Or Authorization Date
- 24-04-2025
- Processing Time Days
- 51
- Number Of Sites
- 1
- Number Of Participants
- 11
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Haematology
- Principal Investigator Name
- Ingerid Weum Abrahamsen
- Principal Investigator Email
- inabra@ous-hf.no
- Contact Person Name
- Ingerid Weum Abrahamsen
- Contact Person Email
- inabra@ous-hf.no
Finland
- Earliest CTIS Part Ii Submission Date
- 03-03-2025
- Latest Decision Or Authorization Date
- 08-04-2025
- Processing Time Days
- 36
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Comprehensive cancer center, Clinical Trial Unit
- Principal Investigator Name
- Mikko Keränen
- Principal Investigator Email
- mikko.keranen@hus.fi
- Contact Person Name
- Mikko Keränen
- Contact Person Email
- mikko.keranen@hus.fi
- Site Name
- Oulu University Hospital
- Department Name
- Clinical Hematology
- Principal Investigator Name
- Marjaana Säily
- Principal Investigator Email
- marjaana.saily@pohde.fi
- Contact Person Name
- Marjaana Säily
- Contact Person Email
- marjaana.saily@pohde.fi
- Site Name
- Turku University Hospital
- Department Name
- Hematology
- Principal Investigator Name
- Juha Ranti
- Principal Investigator Email
- juha.ranti@varha.fi
- Contact Person Name
- Juha Ranti
- Contact Person Email
- juha.ranti@varha.fi
Portugal
- Earliest CTIS Part Ii Submission Date
- 24-02-2025
- Latest Decision Or Authorization Date
- 24-04-2025
- Processing Time Days
- 59
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Hematology and Bone Marrow Transplant Department
- Principal Investigator Name
- José Mário Mariz
- Principal Investigator Email
- mariz@ipoporto.min-saude.pt
- Contact Person Name
- José Mário Mariz
- Contact Person Email
- mariz@ipoporto.min-saude.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 11-02-2025
- Latest Decision Or Authorization Date
- 02-04-2025
- Processing Time Days
- 50
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- Site Name
- University Hospital Son Espases
- Department Name
- Hematology
- Principal Investigator Name
- Antonia Sampol
- Principal Investigator Email
- antonia.sampolm@ssib.es
- Contact Person Name
- Antonia Sampol
- Contact Person Email
- antonia.sampolm@ssib.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Paula Rodriguez Otero
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodriguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- 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 Universitario Virgen De Las Nieves
- Department Name
- Hematology
- Principal Investigator Name
- Maria Esther Clavero
- Principal Investigator Email
- mariae.clavero@juntadeandalucia.es
- Contact Person Name
- Maria Esther Clavero
- Contact Person Email
- mariae.clavero@juntadeandalucia.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematolgy
- Principal Investigator Name
- Laura Abril
- Principal Investigator Email
- labril@iconcologia.net
- Contact Person Name
- Laura Abril
- Contact Person Email
- labril@iconcologia.net
- Site Name
- Clinica Universidad De Navarra (Madrid site)
- Department Name
- Hematology
- Principal Investigator Name
- Paula Rodriguez Otero
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodriguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Hematology
- Principal Investigator Name
- Marta Sonia Gonzalez Perez
- Principal Investigator Email
- marta.sonia.gonzalez.perez@sergas.es
- Contact Person Name
- Marta Sonia Gonzalez Perez
- Contact Person Email
- marta.sonia.gonzalez.perez@sergas.es
- Site Name
- University Hospital Son Espases (additional site listed)
- Department Name
- Hematology
- Principal Investigator Name
- Antonia Sampol
- Principal Investigator Email
- antonia.sampolm@ssib.es
- Contact Person Name
- Antonia Sampol
- Contact Person Email
- antonia.sampolm@ssib.es
Netherlands
- Earliest CTIS Part Ii Submission Date
- 24-03-2025
- Latest Decision Or Authorization Date
- 03-04-2025
- Processing Time Days
- 10
- Number Of Sites
- 4
- Number Of Participants
- 22
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Hematalogy
- Principal Investigator Name
- Rimke Oostvogels
- Principal Investigator Email
- hemat-research@umcutrecht.nl
- Contact Person Name
- Rimke Oostvogels
- Contact Person Email
- hemat-research@umcutrecht.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Hematalogy
- Principal Investigator Name
- Elizabeth de Kort
- Principal Investigator Email
- studies.hemat@radboudumc.nl
- Contact Person Name
- Elizabeth de Kort
- Contact Person Email
- studies.hemat@radboudumc.nl
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Hematalogy
- Principal Investigator Name
- Janine van Elssen
- Principal Investigator Email
- poli.oncologie@mumc.nl
- Contact Person Name
- Janine van Elssen
- Contact Person Email
- poli.oncologie@mumc.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Hematalogy
- Principal Investigator Name
- Sonja Zweegman
- Principal Investigator Email
- ctis@amsterdamumc.nl
- Contact Person Name
- Sonja Zweegman
- Contact Person Email
- ctis@amsterdamumc.nl
Denmark
- Earliest CTIS Part Ii Submission Date
- 05-03-2025
- Latest Decision Or Authorization Date
- 31-03-2025
- Processing Time Days
- 26
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Region Sjaelland
- Department Name
- Department of Hematology
- Principal Investigator Name
- Nicolai Grønne Jørgensen
- Principal Investigator Email
- ngje@regsj.dk
- Contact Person Name
- Nicolai Grønne Jørgensen
- Contact Person Email
- ngje@regsj.dk
- Site Name
- Region Midtjylland
- Department Name
- Department of Hematology
- Principal Investigator Name
- Maja Vase
- Principal Investigator Email
- majavase@rm.dk
- Contact Person Name
- Maja Vase
- Contact Person Email
- majavase@rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Hematology
- Principal Investigator Name
- Anne Kærsgaard Mylin
- Principal Investigator Email
- anne.kaersgaard.mylin@regionh.dk
- Contact Person Name
- Anne Kærsgaard Mylin
- Contact Person Email
- anne.kaersgaard.mylin@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Ida Bruun Kristensen
- Principal Investigator Email
- ida.bruun.kristensen@rsyd.dk
- Contact Person Name
- Ida Bruun Kristensen
- Contact Person Email
- ida.bruun.kristensen@rsyd.dk
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-02-2025
- Latest Decision Or Authorization Date
- 04-04-2025
- Processing Time Days
- 60
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Haematology & Stem Cell Transplantation
- Principal Investigator Name
- Laszlo Zsolt Gopcsa
- Principal Investigator Email
- dpckorhaz@dpckorhaz.hu
- Contact Person Name
- Laszlo Zsolt Gopcsa
- Contact Person Email
- dpckorhaz@dpckorhaz.hu
- Site Name
- University Of Debrecen
- Department Name
- Department of Hematology
- Principal Investigator Name
- Arpad Illes
- Principal Investigator Email
- illes.arpad@med.unideb.hu
- Contact Person Name
- Arpad Illes
- Contact Person Email
- illes.arpad@med.unideb.hu
Greece
- Earliest CTIS Part Ii Submission Date
- 04-12-2024
- Latest Decision Or Authorization Date
- 31-03-2025
- Processing Time Days
- 117
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Evaggelismos Hospital
- Department Name
- Hematology Clinic, Bοne Marrow Tranplanation Unit
- Principal Investigator Name
- Ioannis Baltadakis
- Principal Investigator Email
- ibaltadakis@icloud.com
- Contact Person Name
- Ioannis Baltadakis
- Contact Person Email
- ibaltadakis@icloud.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Bone Marrow Transplantation Unit
- Principal Investigator Name
- Alexandros Spyridonidis
- Principal Investigator Email
- spyridonidis@upatras.gr
- Contact Person Name
- Alexandros Spyridonidis
- Contact Person Email
- spyridonidis@upatras.gr
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Dept of Internal Medicine Division of Hematology
- Principal Investigator Name
- Evangelos Terpos
- Principal Investigator Email
- eterpos@hotmail.com
- Contact Person Name
- Evangelos Terpos
- Contact Person Email
- eterpos@hotmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 03-03-2025
- Latest Decision Or Authorization Date
- 01-04-2025
- Processing Time Days
- 29
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV. interni hematologicka klinika FN Hradec Kralove
- Principal Investigator Name
- Jakub Radocha
- Principal Investigator Email
- jakub.radocha@fnhk.cz
- Contact Person Name
- Jakub Radocha
- Contact Person Email
- jakub.radocha@fnhk.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. interni klinika - klinika hematologie 1.LF a VFN
- Principal Investigator Name
- Jan Straub
- Principal Investigator Email
- jan.straub@vfn.cz
- Contact Person Name
- Jan Straub
- Contact Person Email
- jan.straub@vfn.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Principal Investigator Name
- Jana Mihalyova
- Principal Investigator Email
- jana.mihalyova@fno.cz
- Contact Person Name
- Jana Mihalyova
- Contact Person Email
- jana.mihalyova@fno.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interni hematologicka a onkologicka klinika FN Brno
- Principal Investigator Name
- Ludek Pour
- Principal Investigator Email
- pour.ludek@fnbrno.cz
- Contact Person Name
- Ludek Pour
- Contact Person Email
- pour.ludek@fnbrno.cz
Sponsor
Primary sponsor
- Full Name
- Celgene Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Inc.
- Responsibilities
- Site
- Name
- Medidata Solutions Inc.
- Responsibilities
- 6
- Name
- Signant Health Global LLC
- Responsibilities
- eCOA
- Name
- Clincierge
- Responsibilities
- Patient Reimbursement
Third parties
- {"country":"United States","full_name":"Clincierge","duties_or_roles":"Patient Reimbursement","organisation_type":"Industry"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cellcarta Fremont LLC","duties_or_roles":"Myeloid Derived Suppressor Cells (MDSCs) analysi","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Specialty Biomarker Lab; Proteomic Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"ProtaGene CGT GmbH","duties_or_roles":"RCL","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Flow cytometry, BioA, Smpl mgmt, Kit building, Storage-distrib of smpl to other vendors for analysis","organisation_type":"Health care"}
- {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"Speciality Biomarker Laboratory, IHC Biomarker expression analysis (PD-L1)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Genomic Analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Australia","full_name":"Cellcarta Pty Limited","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Histopatholog, Analytical chemistry","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"Histopathology","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"SME"}
- {"country":"United Kingdom","full_name":"Q2 Solutions (UK address)","duties_or_roles":"Routine clin.pathology testing,Clin.chemistry,Clin.haematology,Clin.microbiology,Histopath,Serology/endocrinology,Analytical chem,ECG analysis/review,Flow cytometry,Smpl mgmt,Kit building,Storage and distrib. of smpls to other vendors for analysis","organisation_type":"Health care"}
- {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Patient Location","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Bioanalytical","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Q2 Solutions, 2 Squared Solutions LLC","duties_or_roles":"Routine clin pathology testing, Clin chemistry, Clin haematology, Clin microbiology, Histopathology, Serology/endocrinology, Analytical chemistry, Flow cytometry, Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis","organisation_type":"Industry"}
- {"country":"United States","full_name":"Adaptive","duties_or_roles":"Genomics","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- GPRC5D-TARGETED CAR T
- Active Substance
- ARLOCABTAGENE AUTOLEUCEL
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous infusion
- Investigational Product Name
- DARATUMUMAB
- Active Substance
- DARATUMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Orphan Designation
- Yes
- Investigational Product Name
- POMALIDOMIDE
- Active Substance
- POMALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Investigational Product Name
- CARFILZOMIB
- Active Substance
- CARFILZOMIB
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Orphan Designation
- Yes
- Investigational Product Name
- DEXAMETHASONE
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS | ORAL
- Route
- Intravenous or Oral
- Investigational Product Name
- CYCLOPHOSPHAMIDE
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- Intravenous injection
- Investigational Product Name
- FLUDARABINE PHOSPHATE
- Active Substance
- FLUDARABINE PHOSPHATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Investigational Product Name
- TOCILIZUMAB
- Active Substance
- TOCILIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Combination Treatment
- Yes
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