Clinical trial • Phase III • Oncology

LINVOSELTAMAB for Relapsed/refractory multiple myeloma

Phase III trial of LINVOSELTAMAB for Relapsed/refractory multiple myeloma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed/refractory multiple myeloma
Trial Stage
Phase III
Drug Modality
Bispecific antibody | Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
03-10-2025
First CTIS Authorization Date
10-02-2026

Trial design

Randomised, open-label, standard-of-care combination regimens (comparator products listed in ctis include darzalex (daratumumab), velcade (bortezomib), dexamethasone, imnovid (pomalidomide) and other local standard agents). no specific doses or schedules for comparator arms are specified in the ctis data.-controlled, adaptive Phase III trial in Austria, Belgium, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard-of-care combination regimens (comparator products listed in CTIS include DARZALEX (daratumumab), VELCADE (bortezomib), Dexamethasone, Imnovid (pomalidomide) and other local standard agents). No specific doses or schedules for comparator arms are specified in the CTIS data.
Adaptive
True, Part 1 includes condensed step-up dosing for linvoseltamab and linvoseltamab + carfilzomib to evaluate safety/tolerability and select the recommended Phase 3 regimens (RP3Rs) for Arms A and B, i.e. dose selection/condensed step-up dosing in an early part followed by randomized Part 2.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
551

Eligibility

Recruits 551 No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial population is adult participants; consent is obtained from adult participants (no paediatric consent/assent procedures described in the CTIS data)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial population is adult participants; consent is obtained from adult participants (no paediatric consent/assent procedures described in the CTIS data).

Inclusion criteria

  • {"criterion_text":"- Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody\n- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2\n- Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy\n- NOTE: Other protocol defined inclusion criteria apply"}

Exclusion criteria

  • {"criterion_text":"- Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded\n- Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n- Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement\n- History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder\n- NOTE: Other protocol defined exclusion criteria apply"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)\n- Part 1 - Severity of TEAEs\n- Part 1 - Occurrence of Adverse Events of Special Interest (AESI)\n- Part 1 - Severity of AESIs\n- Part 1 - Occurrence of Serious Adverse Events (SAEs)\n- Part 1 - Severity of SAEs\n- Part 2 - Minimal Residual Disease (MRD) -negative Complete response (CR)\n- Part 2 - Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC","definition_or_measurement_approach":"Part 1 safety endpoints measured as occurrence and severity of TEAEs/AESIs/SAEs (treatment-emergent adverse events and predefined events of special interest); Part 2 efficacy endpoints: MRD-negative CR assessed per IMWG criteria; PFS assessed per IMWG response criteria as determined by blinded independent review committee (BIRC)."}

Secondary endpoints

  • {"endpoint_text":"- Part 1 - Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)\n- Part 1 - Timing of grade ≥2 CRS\n- Part 2 - Overall Survival (OS)\n- Part 2 - Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC\n- Part 2 - Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC\n- Part 2 - Achievement of CR or better per IMWG response criteria as determined by BIRC\n- Part 2 - Duration Of Response (DOR) as per IMWG response criteria\n- Part 2 - Time To Progression (TTP) as per IMWG response criteria\n- Part 2 - Time To Next Treatment (TTNT)\n- Part 2 - Second PFS\n- Part 2 - MRD-negative CR criteria at any time\n- Part 2 - Time to PR IMWG response category\n- Part 2 - Time to VGPR IMWG response category\n- Part 2 - Time to CR IMWG response category\n- Part 2 - Time to stringent Complete Response (sCR) IMWG response category\n- Part 2 - Sustained of MRD-negative CR\n- Part 2 - Duration of MRD-negative CR\n- Part2 - Occurrence of TEAEs\n- Part 2 - Severity of TEAEs\n- Part 2 - Occurrence of AESIs\n- Part 2 - Severity of AESIs\n- Part 2 - Occurrence of SAEs\n- Part 2 - Severity of SAEs\n- Part 2 - Concentrations of linvoseltamab in serum over time\n- Part 2 - Incidence of Antidrug Antibodies (ADAs) to linvoseltamab\n- Part 2 - Magnitude of ADAs to linvoseltamab\n- Part 2 - Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time\n- Part 2 - Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30)\n- Part 2 - Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30\n- Part 2 - Change from baseline in Role Functioning (RF), per EORTC QLQ-C30\n- Part 2 - Change from baseline in pain, per EORTC QLQ-C30\n- Part 2 - Change from baseline in fatigue, per EORTC QLQ-C30\n- Part 2 - Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])\n- Part 2 - Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20\n- Part 2 - Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)\n- Part 2 - Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5","definition_or_measurement_approach":"Where specified: many efficacy endpoints are defined per IMWG response criteria and/or determined by BIRC (e.g. PR, VGPR, CR, PFS, TTP, TTNT, DOR). Safety endpoints measured as occurrence and severity of TEAEs/AESIs/SAEs; immunogenicity endpoints (ADA incidence/magnitude) and PK endpoints (linvoseltamab serum concentrations) assessed over time per protocol-specified assays; QoL endpoints measured using EORTC QLQ-C30, QLQ-MY20, EQ-5D-5L VAS, and FACIT item GP5."}

Recruitment

Planned Sample Size
551
Recruitment Window Months
102
Consent Approach
Informed consent obtained from adult participants. Subject information and informed consent forms (SIS-ICF) are provided for each participating country; documents available in multiple languages as submitted (e.g. German, Dutch, French, Spanish, Italian, Polish, Czech, Greek, English variants shown in CTIS document list). Additional participant materials include partner/pregnant-partner information forms and data protection notices where applicable.

Methods

  • Site-based recruitment using site recruitment materials (Clariness GmbH listed with responsibility: Site Recruitment Materials).
  • eCOA implementation for patient-facing data capture (Yprime LLC listed with duty: eCOA).
  • Targeted site outreach and site support (WCG Clinical Inc. listed with responsibilities: site service, targeted site outreach and clinical research coordinator site support).
  • Central and local site-based recruitment supported by CRO/partner organisations (ICON Clinical Research Limited, PRA Hellas CRO A.E., IQVIA RDS Inc. involved in trial operations and central services).

Geography

Total Number Of Sites
70
Total Number Of Participants
315

Austria

Earliest CTIS Part Ii Submission Date
22-12-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
56
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Johannes Kepler University Linz
Department Name
Med Campus 3 - Hematology and Oncology
Principal Investigator Name
Clemens Schmitt
Principal Investigator Email
c.schmitt@kepleruniklinikum.at
Contact Person Name
Clemens Schmitt
Contact Person Email
c.schmitt@kepleruniklinikum.at
Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
Hematology
Principal Investigator Name
Agnes List
Principal Investigator Email
agnes.list@oegk.at
Contact Person Name
Agnes List
Contact Person Email
agnes.list@oegk.at
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Oncology
Principal Investigator Name
Sonja Heibl
Principal Investigator Email
Interne4.studienzentrum@klinikum-wegr.at
Contact Person Name
Sonja Heibl
Site Name
Medizinische Universitaet Innsbruck
Department Name
Hematology and Oncology
Principal Investigator Name
Eberhard Gunsilius
Principal Investigator Email
eberhard.gunsilius@tirolkliniken.at
Contact Person Name
Eberhard Gunsilius
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Internal Medicine 1
Principal Investigator Name
Petra Pichler- Izmir
Principal Investigator Email
petra.pichlerizmir@stpoelten.lknoe.at
Contact Person Name
Petra Pichler- Izmir

Belgium

Earliest CTIS Part Ii Submission Date
27-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
14
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
CHC MontLegia
Department Name
Hemato Oncology
Principal Investigator Name
Quentin Perlot
Principal Investigator Email
Quentin.perlot@chc.be
Contact Person Name
Quentin Perlot
Contact Person Email
Quentin.perlot@chc.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Hematology
Principal Investigator Name
Ka Lung Wu
Principal Investigator Email
Kalung.wu@zas.be
Contact Person Name
Ka Lung Wu
Contact Person Email
Kalung.wu@zas.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Principal Investigator Name
Wivine Bernard
Principal Investigator Email
Wivine.bernard@chuuclnamur.be
Contact Person Name
Wivine Bernard
Contact Person Email
Wivine.bernard@chuuclnamur.be
Site Name
UZ Brussel
Department Name
Hematology
Principal Investigator Name
Sylvia Faict
Principal Investigator Email
Sylvia.faict@uzbrussel.be
Contact Person Name
Sylvia Faict
Contact Person Email
Sylvia.faict@uzbrussel.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Hematology
Principal Investigator Name
Natalie Put
Principal Investigator Email
Natalie.put@zol.be
Contact Person Name
Natalie Put
Contact Person Email
Natalie.put@zol.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematology
Principal Investigator Name
Jan Van Droogenbroeck
Principal Investigator Email
Jan.vandroogenbroeck@azsintjan.be
Contact Person Name
Jan Van Droogenbroeck
Site Name
Unknown (site listed with id 188956X)

France

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
18
Number Of Sites
12
Number Of Participants
47

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Adult Hematology Department
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
CHRU De Nancy
Department Name
Hematology Department
Principal Investigator Name
Caroline JACQUET
Principal Investigator Email
jacquet@chru-nancy.fr
Contact Person Name
Caroline JACQUET
Contact Person Email
jacquet@chru-nancy.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology and cell therapy
Principal Investigator Name
Thomas CHALOPIN
Principal Investigator Email
t.chalopin@chu-tours.fr
Contact Person Name
Thomas CHALOPIN
Contact Person Email
t.chalopin@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology Department
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
Site Name
Hospices Civils De Lyon
Department Name
Hematology Department
Principal Investigator Name
Lionel KARLIN
Principal Investigator Email
lionel.karlin@chu-lyon.fr
Contact Person Name
Lionel KARLIN
Contact Person Email
lionel.karlin@chu-lyon.fr
Site Name
Centre Hospitalier Metropole Savoie
Department Name
Hematology Department
Principal Investigator Name
Arthur DONY
Principal Investigator Email
arthur.dony@ch-metropole-savoie.fr
Contact Person Name
Arthur DONY
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology and Cellular Therapy Department
Principal Investigator Name
Xavier LELEU
Principal Investigator Email
xavier.leuleu@chu-poitiers.fr
Contact Person Name
Xavier LELEU
Contact Person Email
xavier.leuleu@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology
Principal Investigator Name
Aurore PERROT
Principal Investigator Email
perrot.aurore@iuct-oncopole.fr
Contact Person Name
Aurore PERROT
Contact Person Email
perrot.aurore@iuct-oncopole.fr
Site Name
Centre Hospitalier Victor Dupouy
Department Name
Hematology Department
Principal Investigator Name
Driss CHAOUI
Principal Investigator Email
driss.chaoui@ch-argenteuil.fr
Contact Person Name
Driss CHAOUI
Contact Person Email
driss.chaoui@ch-argenteuil.fr
Site Name
Institut Gustave Roussy
Department Name
DITEP
Principal Investigator Name
Jean-Marie MICHOT
Principal Investigator Email
jean-marie.michot@gustaveroussy.fr
Contact Person Name
Jean-Marie MICHOT
Site Name
Centre Leon Berard
Department Name
Service of Medical Oncology
Principal Investigator Name
Philippe REY
Principal Investigator Email
philippe.rey@lyon.unicancer.fr
Contact Person Name
Philippe REY
Contact Person Email
philippe.rey@lyon.unicancer.fr
Site Name
Unknown (site listed with id 189572X)

Germany

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
122
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Internal Medicine and Hematology and Oncology
Principal Investigator Name
Katja Weisel
Principal Investigator Email
k.weisel@uke.de
Contact Person Name
Katja Weisel
Contact Person Email
k.weisel@uke.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Internal Medicine and Hematology and Oncology
Principal Investigator Name
Christian Michel
Principal Investigator Email
christian.michel@unimedizinmainz.de
Contact Person Name
Christian Michel
Site Name
Technische Universitaet Dresden
Department Name
Internal Medicine and Hematology and Oncology
Principal Investigator Name
Raphael Teipel
Principal Investigator Email
Raphael.Teipel@ukdd.de
Contact Person Name
Raphael Teipel
Contact Person Email
Raphael.Teipel@ukdd.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Clinic of Hematology and Oncology
Principal Investigator Name
Cyrus Khandanpour
Principal Investigator Email
Cyrus.Khandanpour@uksh.de
Contact Person Name
Cyrus Khandanpour
Contact Person Email
Cyrus.Khandanpour@uksh.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Department of Hematology and Oncology
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 Regensburg AöR
Department Name
Multiples Myelom, Palliativmedizin
Principal Investigator Name
Sabine Gaerditz
Principal Investigator Email
sabine.gaerditz@ukr.de
Contact Person Name
Sabine Gaerditz
Contact Person Email
sabine.gaerditz@ukr.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
Internal Medicine and Hematology and Oncology
Principal Investigator Name
Thomas Illmer
Principal Investigator Email
illmer@onkologie-dresden.net
Contact Person Name
Thomas Illmer
Contact Person Email
illmer@onkologie-dresden.net
Site Name
Kliniken Ostalb
Department Name
Internal Medicine and Hematology
Principal Investigator Name
Holger Hebart
Principal Investigator Email
Holger.Hebart@klinikenostalb.de
Contact Person Name
Holger Hebart

Greece

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
118
Number Of Sites
6
Number Of Participants
41

Sites

Site Name
General Hospital Of Athens Alexandra
Department Name
Department of Clinical Therapeutics, National & Kapodistrian University of Athens
Principal Investigator Name
Meletios Athanasios Dimopoulos
Principal Investigator Email
mdimop@med.uoa.gr
Contact Person Name
Meletios Athanasios Dimopoulos
Contact Person Email
mdimop@med.uoa.gr
Site Name
Olympion Therapeftirio General Clinic Of Patras S.A.
Department Name
Hematology and Oncology Department
Principal Investigator Name
Anargyros (Argiris) Symeonidis
Principal Investigator Email
Argiris.symeonidis@yahoo.gr
Contact Person Name
Anargyros (Argiris) Symeonidis
Contact Person Email
Argiris.symeonidis@yahoo.gr
Site Name
Evangelismos S.A.
Department Name
Hematology and Lymphoma Clinc – 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
Site Name
Theageneio Cancer Hospital
Department Name
Hematology and Oncology Department
Principal Investigator Name
Eirini Katodritou
Principal Investigator Email
Eirini.katodritou@gmail.com
Contact Person Name
Eirini Katodritou
Contact Person Email
Eirini.katodritou@gmail.com
Site Name
University General Hospital Of Ioannina
Department Name
Department of Hematology
Principal Investigator Name
Eleftheria Hatzimichael
Principal Investigator Email
ehatzim@uoi.gr
Contact Person Name
Eleftheria Hatzimichael
Contact Person Email
ehatzim@uoi.gr
Site Name
University General Hospital Of Alexandroupoli
Department Name
Hematology Department
Principal Investigator Name
Emmanouil Spanoudakis
Principal Investigator Email
emmanouilspanoudakis@yahoo.com
Contact Person Name
Emmanouil Spanoudakis
Contact Person Email
emmanouilspanoudakis@yahoo.com

Italy

Earliest CTIS Part Ii Submission Date
28-01-2026
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
16
Number Of Sites
12
Number Of Participants
75

Sites

Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Uoc Ematologia e Trapianto di midoll
Principal Investigator Name
Fabrizio Pane
Principal Investigator Email
Fabrizio.pane@unina.it
Contact Person Name
Fabrizio Pane
Contact Person Email
Fabrizio.pane@unina.it
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
U.O.C. Ematologia eCentro Trapianti di Cellule Staminali Emopoietiche
Principal Investigator Name
Carmine Selleri
Principal Investigator Email
cselleri@unisa.it
Contact Person Name
Carmine Selleri
Contact Person Email
cselleri@unisa.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Onco-hematology
Principal Investigator Name
Claudia Cellini
Principal Investigator Email
Claudia.cellini@auslromagna.it
Contact Person Name
Claudia Cellini
Contact Person Email
Claudia.cellini@auslromagna.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Day Hospital Oncologico
Principal Investigator Name
Delia Rota Scalabrini
Principal Investigator Email
delia.rotascalabrini@ircc.it
Contact Person Name
Delia Rota Scalabrini
Contact Person Email
delia.rotascalabrini@ircc.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
UOC Ematologia e Trapianto di Cellule Staminali Emopoietiche
Principal Investigator Name
Angelo Michele Carella
Principal Investigator Email
Am.carella@operapadrepio.it
Contact Person Name
Angelo Michele Carella
Contact Person Email
Am.carella@operapadrepio.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Hematology
Principal Investigator Name
Francesca Gay
Principal Investigator Email
Francesca.gay@unito.it
Contact Person Name
Francesca Gay
Contact Person Email
Francesca.gay@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Hematology
Principal Investigator Name
Marta Coscia
Principal Investigator Email
Marta.coscia@asst-settelaghi.it
Contact Person Name
Marta Coscia
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
UO Ematologia con Trapianto
Principal Investigator Name
Pellegrino Musto
Principal Investigator Email
Pellegrino.musto@uniba.it
Contact Person Name
Pellegrino Musto
Contact Person Email
Pellegrino.musto@uniba.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Uoc Ematologia
Principal Investigator Name
Angelo Belotti
Principal Investigator Email
angelo.belotti@asst-spedalicivili.it
Contact Person Name
Angelo Belotti
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Ematologia 1
Principal Investigator Name
Silvia Mangiacavalli
Principal Investigator Email
s.mangiacavalli@sanmatteo.pv.it
Contact Person Name
Silvia Mangiacavalli
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Hematology
Principal Investigator Name
Claudio Cerchione
Principal Investigator Email
Claudio.cerchione@irst.emr.it
Contact Person Name
Claudio Cerchione
Contact Person Email
Claudio.cerchione@irst.emr.it
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
SC Hematology
Principal Investigator Name
Vittorio Montefusco
Principal Investigator Email
Vittorio.montefusco@asstsantipaolocarlo.it
Contact Person Name
Vittorio Montefusco

Spain

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
80
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Hospital General Universitario Dr. Balmis
Department Name
Hematology
Principal Investigator Name
Pascual Fernández Abellán
Principal Investigator Email
fernandez_pas@gva.es
Contact Person Name
Pascual Fernández Abellán
Contact Person Email
fernandez_pas@gva.es
Site Name
Hospital Universitario De Cabuenes
Department Name
Hematology
Principal Investigator Name
Maria Esther Gonzalez Garcia
Principal Investigator Email
mariaesther.gonzalez@sespa.es
Contact Person Name
Maria Esther Gonzalez Garcia
Contact Person Email
mariaesther.gonzalez@sespa.es
Site Name
Hospital Universitari Mutua Terrassa
Department Name
Hematology
Principal Investigator Name
Josep María Martí Tutusaus
Principal Investigator Email
jmarti@mutuaterrassa.es
Contact Person Name
Josep María Martí Tutusaus
Contact Person Email
jmarti@mutuaterrassa.es
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
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Hematology
Principal Investigator Name
Paz Ribas Garcia
Principal Investigator Email
ribas_paz@gva.es
Contact Person Name
Paz Ribas Garcia
Contact Person Email
ribas_paz@gva.es

Netherlands

Earliest CTIS Part Ii Submission Date
30-01-2026
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
13
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hematology
Principal Investigator Name
Ruth Wester
Principal Investigator Email
r.wester@erasmusmc.nl
Contact Person Name
Ruth Wester
Contact Person Email
r.wester@erasmusmc.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Hematology
Principal Investigator Name
Aart Beeker
Principal Investigator Email
researchinterne@spaarnegasthuis.nl
Contact Person Name
Aart Beeker
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Hematology
Principal Investigator Name
Paulien van Hauten
Principal Investigator Email
studies.hemat@radboudumc.nl
Contact Person Name
Paulien van Hauten
Contact Person Email
studies.hemat@radboudumc.nl
Site Name
Amphia Hospital
Department Name
Internal medicine – oncology hematology
Principal Investigator Name
Marjolein van der Klift
Principal Investigator Email
researchhematologie@amphia.nl
Contact Person Name
Marjolein van der Klift
Contact Person Email
researchhematologie@amphia.nl

Czechia

Earliest CTIS Part Ii Submission Date
13-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
28
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Principal Investigator Name
Roman Hájek
Principal Investigator Email
roman.hajek@fno.cz
Contact Person Name
Roman Hájek
Contact Person Email
roman.hajek@fno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Hematologická klinika
Principal Investigator Name
Petr Pavlíček
Principal Investigator Email
petr.pavlicek@fnkv.cz
Contact Person Name
Petr Pavlíček
Contact Person Email
petr.pavlicek@fnkv.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interní hematologická klinika
Principal Investigator Name
Jakub Radocha
Principal Investigator Email
radochaj@lfhk.cuni.cz
Contact Person Name
Jakub Radocha
Contact Person Email
radochaj@lfhk.cuni.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Principal Investigator Name
Luděk Pour
Principal Investigator Email
pour.ludek@fnbrno.cz
Contact Person Name
Luděk Pour
Contact Person Email
pour.ludek@fnbrno.cz

Poland

Earliest CTIS Part Ii Submission Date
12-01-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
87
Number Of Sites
7
Number Of Participants
42

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii, Transplantologii i Terapii Komórkowych
Principal Investigator Name
Agata Tyczyńska
Principal Investigator Email
hematologia@uck.gda.pl
Contact Person Name
Agata Tyczyńska
Contact Person Email
hematologia@uck.gda.pl
Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name
Oddział Hematologiczny
Principal Investigator Name
Aleksandra Butrym
Principal Investigator Email
onkocwbk@zdrowie.walbrzych.pl
Contact Person Name
Aleksandra Butrym
Contact Person Email
onkocwbk@zdrowie.walbrzych.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
sgrosicki@wp.pl
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Ukladu Chlonnego
Principal Investigator Name
Joanna Romejko- Jarosińska
Principal Investigator Email
joanna.romejko-jarosinska@pib-nio.pl
Contact Person Name
Joanna Romejko- Jarosińska
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Oddział Wieloprofilowy Zachowawczy
Principal Investigator Name
Krzysztof Giannopoulos
Principal Investigator Email
cit@usk4.lublin.pl
Contact Person Name
Krzysztof Giannopoulos
Contact Person Email
cit@usk4.lublin.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Principal Investigator Name
Tomasz Wróbel
Principal Investigator Email
khn@usk.wroc.pl
Contact Person Name
Tomasz Wróbel
Contact Person Email
khn@usk.wroc.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematoonkologii i Chorób Wewnętrznych z Pododdziałem Chemioterapii Dziennej
Principal Investigator Name
Paweł Robak
Principal Investigator Email
badania.kliniczne@kopernik.lodz.pl
Contact Person Name
Paweł Robak

Sponsor

Primary sponsor

Full Name
Regeneron Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Name
PRA Hellas CRO A.E.
Responsibilities
legal entity in Greece
Name
IQVIA (Iqvia Rds Inc.)

Third parties

  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Site Recruitment Materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Millmount Healthcare Limited","duties_or_roles":"Drug Supply and Logistics","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"specialty Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"site service, targeted site outreach and clinical research coordinator site support","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"legal entity in Greece","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"IDMC Management","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Lab","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Portfolio Manager","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"translations","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LYNOZYFIC 5 mg concentrate for solution for infusion / LYNOZYFIC 200 mg concentrate for solution for infusion
Active Substance
LINVOSELTAMAB
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation number EU/1/25/1917/001 and EU/1/25/1917/002 (prodAuthStatus: 2)
Investigational Product Name
Kyprolis 60 mg / Kyprolis 30 mg / Kyprolis 10 mg powder for solution for infusion
Active Substance
CARFILZOMIB
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation numbers EU/1/15/1060/001, /002, /003 (prodAuthStatus: 2)
Combination Treatment
Yes

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