Clinical trial • Phase III • Oncology
Linvoseltamab for Relapsed/Refractory Multiple Myeloma | Multiple myeloma
Phase III trial of Linvoseltamab for Relapsed/Refractory Multiple Myeloma | Multiple myeloma. 309 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed/Refractory Multiple Myeloma | Multiple myeloma
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 22-05-2024
- First CTIS Authorization Date
- 27-06-2024
Trial design
Phase III trial across 27 sites in Spain, Greece, France and others.
- Target Sample Size
- 309
Eligibility
Recruits 309 Vulnerable population selected; no details on consent or assent available..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent available.
Recruitment
- Planned Sample Size
- 309
- Recruitment Window Months
- 145
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 309
Spain
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 27-06-2024
- Processing Time Days
- 23
- Number Of Sites
- 13
- Number Of Participants
- 111
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Hematology
- Principal Investigator Name
- Marta Sonia Gonzalez Perez
- Principal Investigator Email
- marta.sonia.gonzalez.perez@sergas.es
- Contact Person Name
- Marta Sonia Gonzalez Perez
- Contact Person Email
- marta.sonia.gonzalez.perez@sergas.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Ana Maria Sureda Balari
- Principal Investigator Email
- asureda@iconcologia.net
- Contact Person Name
- Ana Maria Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Paula Rodriguez Otero
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodriguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- 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 Universitario Ramon Y Cajal
- Department Name
- Hematology
- Principal Investigator Name
- Maria Jesús Blanchard Rodriguez
- Principal Investigator Email
- mariajesus.blanchard@salud.madrid.org
- Contact Person Name
- Maria Jesús Blanchard Rodriguez
- Contact Person Email
- mariajesus.blanchard@salud.madrid.org
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematology
- Principal Investigator Name
- Maria del Carmen Martinez Chamorro
- Principal Investigator Email
- mcarmen.chamorro@quironsalud.es
- Contact Person Name
- Maria del Carmen Martinez Chamorro
- Contact Person Email
- mcarmen.chamorro@quironsalud.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Mercedes Gironella Mesa
- Principal Investigator Email
- mgironella@vhio.net
- Contact Person Name
- Mercedes Gironella Mesa
- Contact Person Email
- mgironella@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Carlos Fernandez de Larrea Rodriguez
- Principal Investigator Email
- CFERNAN1@clinic.cat
- Contact Person Name
- Carlos Fernandez de Larrea Rodriguez
- Contact Person Email
- CFERNAN1@clinic.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Joaquin Martinez Lopez
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquin Martinez Lopez
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- Maria Victoria Mateos Manteca
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- Maria Victoria Mateos Manteca
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Hematology
- Principal Investigator Name
- Damián Cubillas Garcia de la Torres
- Principal Investigator Email
- damian.cubillas@startresearch.com
- Contact Person Name
- Damián Cubillas Garcia de la Torres
- Contact Person Email
- damian.cubillas@startresearch.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hematology
- Principal Investigator Name
- Enrique Maria Ocio San Miguel
- Principal Investigator Email
- enriquem.ocio@unican.es
- Contact Person Name
- Enrique Maria Ocio San Miguel
- Contact Person Email
- enriquem.ocio@unican.es
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Hematology
- Principal Investigator Name
- Adrián Alegre Amor
- Principal Investigator Email
- aalegre.hlpr@salud.madrid.org
- Contact Person Name
- Adrián Alegre Amor
- Contact Person Email
- aalegre.hlpr@salud.madrid.org
Greece
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 07-08-2024
- Processing Time Days
- 64
- Number Of Sites
- 2
- Number Of Participants
- 70
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Oncology and Hematology Unit, Department of Clinical
- Principal Investigator Name
- Athanasios Meletios Dimopoulos
- Principal Investigator Email
- mdimop@med.uoa.gr
- Contact Person Name
- Athanasios Meletios Dimopoulos
- Contact Person Email
- mdimop@med.uoa.gr
- Site Name
- Evaggelismos Hospital
- Department Name
- Hematology and Lymphoma Clinic – Bone Marrow Transplantation Unit
- Principal Investigator Name
- Sosana Delimpasi
- Principal Investigator Email
- sodeli@yahoo.com
- Contact Person Name
- Sosana Delimpasi
- Contact Person Email
- sodeli@yahoo.com
France
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 02-07-2024
- Processing Time Days
- 28
- Number Of Sites
- 10
- Number Of Participants
- 88
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hematologie clinique
- Principal Investigator Name
- Laure Vincent
- Principal Investigator Email
- l-vincent@chu-montpellier.fr
- Contact Person Name
- Laure Vincent
- Contact Person Email
- l-vincent@chu-montpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Département d'hématologie
- Principal Investigator Name
- Laurent Frenzel
- Principal Investigator Email
- laurent.frenzel@aphp.fr
- Contact Person Name
- Laurent Frenzel
- Contact Person Email
- laurent.frenzel@aphp.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Service Maladies du Sang
- Principal Investigator Name
- Mamoun Dib
- Principal Investigator Email
- Madib@chu-angers.fr
- Contact Person Name
- Mamoun Dib
- Contact Person Email
- Madib@chu-angers.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hématologie Clinique et thérapie cellulaire
- Principal Investigator Name
- Mohamad Mothy
- Principal Investigator Email
- Mohamad.mohty@inserm.fr
- Contact Person Name
- Mohamad Mothy
- Contact Person Email
- Mohamad.mohty@inserm.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service Immuno-hématologie
- Principal Investigator Name
- Bertrand Arnulf
- Principal Investigator Email
- Bertrand.arnulf@aphp.fr
- Contact Person Name
- Bertrand Arnulf
- Contact Person Email
- Bertrand.arnulf@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hémopathies Lymphoïdes
- Principal Investigator Name
- Karim Belhadj
- Principal Investigator Email
- Karim.belhadj@aphp.fr
- Contact Person Name
- Karim Belhadj
- Contact Person Email
- Karim.belhadj@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d’hématologie et Thérapie Cellulaire Pôle Régional de Cancérologie
- 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
- Site Name
- Institut Gustave Roussy
- Department Name
- Hématologie
- Principal Investigator Name
- Jean – Marie Michot
- Principal Investigator Email
- jean-marie.michot@gustaveroussy.fr
- Contact Person Name
- Jean – Marie Michot
- Contact Person Email
- jean-marie.michot@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Département d’hématologie
- Principal Investigator Name
- Salomon Manier
- Principal Investigator Email
- salomon.manier@chru-lille.fr
- Contact Person Name
- Salomon Manier
- Contact Person Email
- salomon.manier@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Département d'hématologie
- Principal Investigator Name
- Cyrille Touzeau
- Principal Investigator Email
- Cyrille.touzeau@chu-nantes.fr
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- Cyrille.touzeau@chu-nantes.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-02-2026
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 23
- Number Of Sites
- 2
- Number Of Participants
- 40
Sites
- Site Name
- VUMC 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
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Hematology
- Principal Investigator Name
- Wouter Plattel
- Principal Investigator Email
- w.j.plattel@umcg.nl
- Contact Person Name
- Wouter Plattel
- Contact Person Email
- w.j.plattel@umcg.nl
Sponsor
Primary sponsor
- Full Name
- Regeneron Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Linvoseltamab
- Combination Treatment
- Yes
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