Clinical trial • Phase III • Oncology
belantamab mafodotin for Multiple myeloma
Phase III trial of belantamab mafodotin for Multiple myeloma. 54 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 19-01-2024
- First CTIS Authorization Date
- 26-02-2024
Trial design
Phase III trial across 14 sites in Italy, Spain, France and others.
- Target Sample Size
- 54
Eligibility
Recruits 54 Vulnerable population selected (isVulnerablePopulationSelected = true) in CTIS record; no details on consent or assent handling are provided in the source JSON..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true) in CTIS record; no details on consent or assent handling are provided in the source JSON.
Recruitment
- Planned Sample Size
- 54
- Recruitment Window Months
- 79
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 67
Italy
- Earliest CTIS Part Ii Submission Date
- 07-02-2024
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Divisione di Ematologia
- 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
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Istituto di Ematologia Seragnoli
- Principal Investigator Name
- Michele Cavo
- Principal Investigator Email
- michele.cavo@gmail.com
- Contact Person Name
- Michele Cavo
- Contact Person Email
- michele.cavo@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 07-02-2024
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 19
- Number Of Sites
- 7
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hematología
- Principal Investigator Name
- Enrique María Ocio San Miguel
- Principal Investigator Email
- enriquem.ocio@unican.es
- Contact Person Name
- Enrique María Ocio San Miguel
- Contact Person Email
- enriquem.ocio@unican.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematología
- Principal Investigator Name
- Paula Rodríguez Otero
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodríguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematología
- Principal Investigator Name
- Albert Oriol Rocafiguera
- Principal Investigator Email
- aoriol@iconcologia.net
- Contact Person Name
- Albert Oriol Rocafiguera
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematología
- Principal Investigator Name
- Laura Rosiñol Dachs
- Principal Investigator Email
- ENSAYOSHEMATOLOGIA@clinic.cat
- Contact Person Name
- Laura Rosiñol Dachs
- Contact Person Email
- ENSAYOSHEMATOLOGIA@clinic.cat
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematología
- Principal Investigator Name
- Aranzazu Alonso Alonso
- Principal Investigator Email
- aranzazu.alonso@quironsalud.es
- Contact Person Name
- Aranzazu Alonso Alonso
- Contact Person Email
- aranzazu.alonso@quironsalud.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Hematología
- Principal Investigator Name
- Ricarda García Sánchez
- Principal Investigator Email
- ricarda_g@yahoo.es
- Contact Person Name
- Ricarda García Sánchez
- Contact Person Email
- ricarda_g@yahoo.es
- Site Name
- Hospital Universitario Virgen De La Victoria (additional entry in record)
- Department Name
- Hematología
France
- Earliest CTIS Part Ii Submission Date
- 07-02-2024
- Latest Decision Or Authorization Date
- 27-02-2024
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d’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
Germany
- Earliest CTIS Part Ii Submission Date
- 07-02-2024
- Latest Decision Or Authorization Date
- 27-02-2024
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Gemeinschaftspraxis Haematologie Onkologie
- Principal Investigator Name
- Thomas Illmer
- Principal Investigator Email
- illmer@onkologie-dresden.net
- Contact Person Name
- Thomas Illmer
- Contact Person Email
- illmer@onkologie-dresden.net
- 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
Poland
- Earliest CTIS Part Ii Submission Date
- 07-02-2024
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 26
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Oddział Hematologii, Transplantacji Szpiku i Chemioterapii
- Principal Investigator Name
- Marek Hus
- Principal Investigator Email
- hematoonkologia@spsk1.lublin.pl
- Contact Person Name
- Marek Hus
- Contact Person Email
- hematoonkologia@spsk1.lublin.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Dominik Dytfeld
- Principal Investigator Email
- badania.hematologia@usk.poznan.pl
- Contact Person Name
- Dominik Dytfeld
- Contact Person Email
- badania.hematologia@usk.poznan.pl
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- GSK2857916 (belantamab mafodotin)
- Active Substance
- belantamab mafodotin
- Modality
- ADC
- Combination Treatment
- Yes
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