Clinical trial • Phase I • Haematology
Teclistamab for Relapsed/refractory multiple myeloma
Phase I trial of Teclistamab for Relapsed/refractory multiple myeloma.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Relapsed/refractory multiple myeloma
- Trial Stage
- Phase I
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 09-02-2024
- First CTIS Authorization Date
- 03-06-2024
Trial design
Randomised, open-label, pre-change teclistamab vs post-change teclistamab (no dose or schedule specified in the provided data)-controlled Phase I trial across 29 sites in Spain, France, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Pre-change teclistamab vs post-change teclistamab (no dose or schedule specified in the provided data)
- Target Sample Size
- 52
Eligibility
Recruits 52 Vulnerable population selected; no information on consent or assent handling provided in the available documents..
- Vulnerable Population
- Vulnerable population selected; no information on consent or assent handling provided in the available documents.
Recruitment
- Planned Sample Size
- 52
- Recruitment Window Months
- 31
- Consent Approach
- No informed consent or assent process details provided in the available documents. Vulnerable population is selected but consent/assent handling is not described.
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 48
Spain
- Earliest CTIS Part Ii Submission Date
- 28-02-2024
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 709
- Number Of Sites
- 8
- Number Of Participants
- 9
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Anna Sureda
- Principal Investigator Email
- asureda@iconcologia.net
- Contact Person Name
- Anna Sureda
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Joaquin Martinez
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquin Martinez
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematology
- Principal Investigator Name
- Carmen Martinez-Chamorro
- Principal Investigator Email
- carmenmartinezchamorro@hotmail.com
- Contact Person Name
- Carmen Martinez-Chamorro
- Contact Person Email
- carmenmartinezchamorro@hotmail.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- Maria Victoria Mateos
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- Maria Victoria Mateos
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Carlos Fernandez de Larrea
- Principal Investigator Email
- cfernan1@clinic.cat
- Contact Person Name
- Carlos Fernandez de Larrea
- Contact Person Email
- cfernan1@clinic.cat
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Paula Rodriguez
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodriguez
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hematology
- Principal Investigator Name
- Enrique Ocio
- Principal Investigator Email
- ocioem@unican.es
- Contact Person Name
- Enrique Ocio
- Contact Person Email
- ocioem@unican.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology
- Principal Investigator Name
- Daniel Morillo
- Principal Investigator Email
- dmorillo@startmadrid.com
- Contact Person Name
- Daniel Morillo
- Contact Person Email
- dmorillo@startmadrid.com
France
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 637
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hematology Department
- 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
- Hospices Civils De Lyon
- Department Name
- Hematology Department
- 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
- Blood diseases service
- Principal Investigator Name
- Salomon MANIER
- Principal Investigator Email
- salomon.manier@chu-lille.fr
- Contact Person Name
- Salomon MANIER
- Contact Person Email
- salomon.manier@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hematology Department
- 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
Germany
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 657
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Poliklinik gGmbH Chemnitz
- Department Name
- Klinik für Innere Medizin III
- 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
- 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
- Leo Rasche
- Principal Investigator Email
- rasche_l@ukw.de
- Contact Person Name
- Leo Rasche
- Contact Person Email
- rasche_l@ukw.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Innere Medizin V, Haematologie, Onkologie und Rheumatologie
- Principal Investigator Name
- Marc Raab
- Principal Investigator Email
- marc.raab@uni-heidelberg.de
- Contact Person Name
- Marc Raab
- Contact Person Email
- marc.raab@uni-heidelberg.de
Poland
- Earliest CTIS Part Ii Submission Date
- 30-04-2024
- Latest Decision Or Authorization Date
- 08-02-2026
- Processing Time Days
- 649
- Number Of Sites
- 7
- Number Of Participants
- 9
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
- legiec.wojciech@gmail.com
- Contact Person Name
- Wojciech Legieć
- Contact Person Email
- legiec.wojciech@gmail.com
- Site Name
- Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
- Department Name
- Oddział Hematologii
- Principal Investigator Name
- Piotr Centkowski
- Principal Investigator Email
- pcentek@wp.pl
- Contact Person Name
- Piotr Centkowski
- Contact Person Email
- pcentek@wp.pl
- Site Name
- Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
- Department Name
- Centrum Hematologiczno-Transplantacyjne
- Principal Investigator Name
- Jarosław Dybko
- Principal Investigator Email
- jaroslaw.dybko@dcopih.pl
- Contact Person Name
- Jarosław Dybko
- Contact Person Email
- jaroslaw.dybko@dcopih.pl
- Site Name
- Medical University Of Warsaw
- Department Name
- Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
- Principal Investigator Name
- Krzysztof Jamroziak
- Principal Investigator Email
- krzysztof.jamroziak@wum.edu.pl
- Contact Person Name
- Krzysztof Jamroziak
- Contact Person Email
- krzysztof.jamroziak@wum.edu.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Agata Tyczyńska
- Principal Investigator Email
- atyczynska@uck.gda.pl
- Contact Person Name
- Agata Tyczyńska
- Contact Person Email
- atyczynska@uck.gda.pl
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Klinika Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Paweł Steckiewicz
- Principal Investigator Email
- badania.kliniczne@onkol.kielce.pl
- Contact Person Name
- Paweł Steckiewicz
- Contact Person Email
- badania.kliniczne@onkol.kielce.pl
- 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
Italy
- Earliest CTIS Part Ii Submission Date
- 23-04-2024
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 652
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- UO 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
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD Clinica Ematologica
- Principal Investigator Name
- Massimo Offidani
- Principal Investigator Email
- massimo.offidani@ospedaliriuniti.marche.it
- Contact Person Name
- Massimo Offidani
- Contact Person Email
- massimo.offidani@ospedaliriuniti.marche.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Ematologia
- Principal Investigator Name
- Gabriele Buda
- Principal Investigator Email
- g.buda@ao-pisa.toscana.it
- Contact Person Name
- Gabriele Buda
- Contact Person Email
- g.buda@ao-pisa.toscana.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UO Ematologia
- Principal Investigator Name
- Valerio De Stefano
- Principal Investigator Email
- valerio.destefano@unicatt.it
- Contact Person Name
- Valerio De Stefano
- Contact Person Email
- valerio.destefano@unicatt.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- UO Ematologia
- Principal Investigator Name
- Angelo Belotti
- Principal Investigator Email
- angelo.belotti@asst-spedalicivili.it
- Contact Person Name
- Angelo Belotti
- Contact Person Email
- angelo.belotti@asst-spedalicivili.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- UO Oncoematologia
- Principal Investigator Name
- Claudio Cerchione
- Principal Investigator Email
- claudio.cerchione@irst.emr.it
- Contact Person Name
- Claudio Cerchione
- Contact Person Email
- claudio.cerchione@irst.emr.it
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Teclistamab
- Active Substance
- Teclistamab
- Modality
- Bispecific antibody
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