Clinical trial • Oncology

Etentamig (ABBV-383) for Light chain amyloidosis

Clinical trial of Etentamig (ABBV-383) for Light chain amyloidosis. None/Not specified-controlled. 60 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Light chain amyloidosis

Key dates

Initial CTIS Submission Date
15-01-2024
First CTIS Authorization Date
06-05-2024

Trial design

None/Not specified-controlled trial across 5 sites in France, Greece, Italy.

Comparator
None/Not specified
Target Sample Size
60

Recruitment

Planned Sample Size
60
Recruitment Window Months
85

Geography

Total Number Of Sites
5
Total Number Of Participants
60

France

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
06-05-2024
Processing Time Days
19
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Département de néphrologie et transplantation d'organes
Principal Investigator Name
Antoine Huart
Principal Investigator Email
huart.a@chu-toulouse.fr
Contact Person Name
Antoine Huart
Contact Person Email
huart.a@chu-toulouse.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service d'Hématologie Clinique et Thérapie Cellulaire
Principal Investigator Name
Arnaud Jaccard
Principal Investigator Email
arnaud.jaccard@chu-limoges.fr
Contact Person Name
Arnaud Jaccard
Contact Person Email
arnaud.jaccard@chu-limoges.fr

Greece

Earliest CTIS Part Ii Submission Date
04-04-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
39
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Alexandra Hospital
Department Name
Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics
Principal Investigator Name
Efstathios Kastritis
Principal Investigator Email
ekastritis@med.uoa.gr
Contact Person Name
Efstathios Kastritis
Contact Person Email
ekastritis@med.uoa.gr

Italy

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
08-05-2024
Processing Time Days
41
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
General Medicine 2
Principal Investigator Name
Giovanni Palladini
Principal Investigator Email
Giovanni.palladini@unipv.it
Contact Person Name
Giovanni Palladini
Contact Person Email
Giovanni.palladini@unipv.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Department of Oncological and Hematological Diseases
Principal Investigator Name
Elena Zamagni
Principal Investigator Email
e.zamagni@unibo.it
Contact Person Name
Elena Zamagni
Contact Person Email
e.zamagni@unibo.it

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)

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