Clinical trial • Phase III • Oncology
Etentamig (ABBV-383) for Relapsed/Refractory Multiple Myeloma
Phase III trial of Etentamig (ABBV-383) for Relapsed/Refractory Multiple Myeloma. 254 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed/Refractory Multiple Myeloma
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 20-11-2023
- First CTIS Authorization Date
- 10-01-2024
Trial design
Phase III trial across 22 sites in Germany, Spain, Italy and others.
- Target Sample Size
- 254
Recruitment
- Planned Sample Size
- 254
- Recruitment Window Months
- 79
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 196
Germany
- Earliest CTIS Part Ii Submission Date
- 12-12-2023
- Latest Decision Or Authorization Date
- 10-01-2024
- Processing Time Days
- 29
- Number Of Sites
- 5
- Number Of Participants
- 50
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Contact Person Name
- Katja Weisel
- Contact Person Email
- Onko-Studienzentrum@uke.de
- Site Name
- Universitaetsklinikum Regensburg
- Contact Person Name
- Sabine Gaerditz
- Contact Person Email
- Ectu.Ukr@klinik.uni-regensburg.de
- Site Name
- Universitaetsklinikum Essen AöR
- Contact Person Name
- Christine Hanoun
- Contact Person Email
- studienzentrum-haemaSZT@uk-essen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Contact Person Name
- Britta Besemer
- Contact Person Email
- Britta.Besemer@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Contact Person Name
- Martin Kortuem
- Contact Person Email
- Kortuem_M@ukw.de
Spain
- Earliest CTIS Part Ii Submission Date
- 12-12-2023
- Latest Decision Or Authorization Date
- 15-01-2024
- Processing Time Days
- 34
- Number Of Sites
- 8
- Number Of Participants
- 48
Sites
- Site Name
- Clinica Universidad De Navarra
- Contact Person Name
- Paula Rodriguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Institut Catala D'oncologia
- Contact Person Name
- Anna Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Contact Person Name
- Mercedes Gironella Mesa
- Contact Person Email
- mgironella@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Contact Person Name
- Laura Rosinol Dachs
- Contact Person Email
- lrosinol@clinic.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Contact Person Name
- Joaquín Martinez Lopez
- Contact Person Email
- jmartinezlo1967@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Contact Person Name
- Estrella Carrillo Cruz
- Contact Person Email
- estrellacarrillocruz@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Contact Person Name
- Paula Rodriguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Contact Person Name
- Paula Rodriguez Otero
- Contact Person Email
- paurodriguez@unav.es
Italy
- Earliest CTIS Part Ii Submission Date
- 12-12-2023
- Latest Decision Or Authorization Date
- 12-01-2024
- Processing Time Days
- 31
- Number Of Sites
- 5
- Number Of Participants
- 49
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Haematology
- Contact Person Name
- Elena Zamagni
- Contact Person Email
- elena.zamagni@aosp.bo.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Haematology
- Contact Person Name
- Claudio Cerchione
- Contact Person Email
- claudio.cerchione@irst.emr.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Haematology
- Contact Person Name
- Matteo Claudio Da Vià
- Contact Person Email
- matteo.davia@policlinico.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Haematology
- Contact Person Name
- Valerio De Stefano
- Contact Person Email
- valerio.destefano@unicatt.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Haematology
- Contact Person Name
- Fabio Ciceri
- Contact Person Email
- fabio.ciceri@hsr.it
Poland
- Earliest CTIS Part Ii Submission Date
- 12-12-2023
- Latest Decision Or Authorization Date
- 15-03-2024
- Processing Time Days
- 94
- Number Of Sites
- 4
- Number Of Participants
- 49
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Department of Hematology, Cell Therapies and Internal Diseases
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- tomasz_wrobel@wp.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Department of Hematology and Transplantology
- Contact Person Name
- Monika Szarejko
- Contact Person Email
- monasza1@gumed.edu.pl
- Site Name
- Szpital Wojewodzki W Opolu Sp. z o.o.
- Department Name
- Department of Hematology, Hematological Oncology and Internal Medicine
- Contact Person Name
- Dariusz Woszczyk
- Contact Person Email
- dariusz.s.woszczyk@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Department of Hematooncology and Bone Marrow Transplantation
- Contact Person Name
- Marek Hus
- Contact Person Email
- markhus@o2.pl
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Etentamig (ABBV-383)
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Combination Treatment
- Yes
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