Clinical trial • Phase III • Oncology
daratumumab for Multiple myeloma
Phase III trial of daratumumab for Multiple myeloma. 179 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 25-04-2024
- First CTIS Authorization Date
- 07-06-2024
Trial design
Phase III trial across 12 sites in Germany, Spain, Netherlands.
- Target Sample Size
- 179
Eligibility
Recruits 179 Vulnerable population selected; consent/assent handling not specified in provided data..
- Vulnerable Population
- Vulnerable population selected; consent/assent handling not specified in provided data.
Recruitment
- Planned Sample Size
- 179
- Recruitment Window Months
- 85
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 111
Germany
- Earliest CTIS Part Ii Submission Date
- 16-05-2024
- Latest Decision Or Authorization Date
- 14-11-2025
- Processing Time Days
- 547
- Number Of Sites
- 4
- Number Of Participants
- 29
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Innere Medizin I, Hämatologie/Onkologie,
- Principal Investigator Name
- Ralph Waesch
- Principal Investigator Email
- ralph.waesch@uniklinik-freiburg.de
- Contact Person Name
- Ralph Waesch
- Contact Person Email
- ralph.waesch@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II; Abt. für Onkologie/Hämatologie
- 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
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Innere Medizin V Hämatologie/Onkologie
- Principal Investigator Name
- Hartmut Goldschmidt
- Principal Investigator Email
- hartmut.goldschmidt@med.uni-heidelberg.de
- Contact Person Name
- Hartmut Goldschmidt
- Contact Person Email
- hartmut.goldschmidt@med.uni-heidelberg.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Medizinische Klinik und Poliklinik 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
Spain
- Earliest CTIS Part Ii Submission Date
- 16-05-2024
- Latest Decision Or Authorization Date
- 14-11-2025
- Processing Time Days
- 547
- Number Of Sites
- 7
- Number Of Participants
- 70
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Daniel Morillo
- Principal Investigator Email
- dmorillo@startmadrid.com
- Contact Person Name
- Daniel Morillo
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Medical Oncology
- Principal Investigator Name
- Albert Oriol
- Principal Investigator Email
- aoriol@iconcologia.net
- Contact Person Name
- Albert Oriol
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Anna Sureda
- Principal Investigator Email
- asureda@iconcologia.net
- Contact Person Name
- Anna Sureda
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jesus San Miguel
- Principal Investigator Email
- sanmiguel@unav.es
- Contact Person Name
- Jesus San Miguel
- Contact Person Email
- sanmiguel@unav.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Medical Oncology
- Principal Investigator Name
- María Victoria Mateos
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- María Victoria Mateos
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laura Rosiñol
- Principal Investigator Email
- lrosinol@clinic.cat
- Contact Person Name
- Laura Rosiñol
- Contact Person Email
- lrosinol@clinic.cat
- Site Name
- Institut Catala D'oncologia (duplicate entry as per source)
- Department Name
- Medical Oncology
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-05-2024
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 548
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Hematology
- 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
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Daratumumab (subcutaneous)
- Active Substance
- daratumumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Investigational Product Name
- Bispecific T cell redirection antibodies
- Modality
- Bispecific antibody
- Combination Treatment
- Yes
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