Clinical trial • Phase III • Oncology
Etentamig (ABBV-383) for Relapsed or refractory multiple myeloma
Phase III trial of Etentamig (ABBV-383) for Relapsed or refractory multiple myeloma. 25 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory multiple myeloma
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 17-01-2024
- First CTIS Authorization Date
- 13-05-2024
Trial design
Phase III trial across 8 sites in France, Germany.
- Target Sample Size
- 25
Eligibility
Recruits 25 Vulnerable population selected; no further details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 25
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 30
France
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 14-05-2024
- Processing Time Days
- 26
- Number Of Sites
- 6
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d'Hématologie et Thérapie Cellulaire
- Contact Person Name
- Xavier Leleu
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Département Hématologie Clinique
- Contact Person Name
- Laure Vincent
- Contact Person Email
- l-vincent@chu-montpellier.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Département Hématologie
- Contact Person Name
- Lionel Karlin
- Contact Person Email
- lionel.karlin@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Département Hématologie Clinique
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- cyrille.touzeau@chu-nantes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Unité Hémopathies Lymphoïdes
- Contact Person Name
- Karim Belhadj
- Contact Person Email
- karim.belhadj@aphp.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Département Oncologie Médicale - Unité de phase précoce
- Contact Person Name
- Pierre Bories
- Contact Person Email
- bories.pierre@iuct-oncopole.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 733
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Contact Person Name
- Katja Weisel
- Contact Person Email
- Onko-Studienzentrum@uke.de
- Site Name
- Goethe University Frankfurt
- Contact Person Name
- Ivana von Metzler
- Contact Person Email
- studienservice@med.uni-frankfurt.de
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
- Subcutaneous
- Route
- Subcutaneous
Related trials
Other published trials that may interest you.