Clinical trial • Phase III • Oncology

LINVOSELTAMAB for Multiple myeloma | Newly diagnosed transplant-ineligible multiple myeloma

Phase III trial of LINVOSELTAMAB for Multiple myeloma | Newly diagnosed transplant-ineligible multiple myeloma.

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Multiple myeloma | Newly diagnosed transplant-ineligible multiple myeloma
Trial Stage: Phase III
Drug Modality: Bispecific antibody | Monoclonal antibody | Small molecule
Orphan Drug: Yes

Key dates

Initial CTIS Submission Date: 09-05-2025
First CTIS Authorization Date: 01-09-2025

Trial design

Randomised, open-label, daratumumab + lenalidomide + dexamethasone induction followed by linvoseltamab versus continued daratumumab + lenalidomide + dexamethasone (no schedules/doses specified in ctis record).-controlled Phase III trial in Croatia, Czechia, Estonia and others.

Randomised: Yes
Open Label: Yes
Comparator: Daratumumab + Lenalidomide + Dexamethasone induction followed by Linvoseltamab versus continued Daratumumab + Lenalidomide + Dexamethasone (no schedules/doses specified in CTIS record).
Target Sample Size: 217

Eligibility

Recruits 217 Only adults (Age 18 years or older or legal adult age in country) are eligible. Informed consent must be provided by the study patient ("Provide informed consent signed by study patient."). The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Country-specific informed consent documents are provided (local ICFs per country files) and participation requires a signed ICF from the adult participant; no paediatric assent procedures are included..

Pregnancy Exclusion: "Pregnant or breastfeeding females."
Vulnerable Population: Only adults (Age 18 years or older or legal adult age in country) are eligible. Informed consent must be provided by the study patient ("Provide informed consent signed by study patient."). The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Country-specific informed consent documents are provided (local ICFs per country files) and participation requires a signed ICF from the adult participant; no paediatric assent procedures are included.

Inclusion criteria

{"criterion_text":"- Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria (Appendix 1)."}
{"criterion_text":"- Provide informed consent signed by study patient."}
{"criterion_text":"- Able to understand and complete study-related questionnaires."}
{"criterion_text":"- Age 18 years (or legal adult age in the country) or older at the time of informed consent."}
{"criterion_text":"- Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT due to: advanced age with or without comorbidities or for patients aged 18-69 the presence of significant comorbidities that are likely to have a negative impact on tolerability of HDT-ASCT The reason(s) for transplant ineligibility must be provided by the investigator."}
{"criterion_text":"- Participants must have measurable disease, as defined by at least 1 of the following (according to the 2016 IMWG response criteria): Serum monoclonal protein level ≥1 g/dL Quantitative immunoglobulin levels of ≥1 g/dL (Immunoglobulin A [IgA] and immunoglobulin D [IgD] myeloma only). Note: for IgA and IgD myelomas, quantitative immunoglobulin measurements are preferred for disease assessments (Visram et al., 2021). Urinary M-protein level of ≥200 mg over a 24-hour period Involved serum FLC level ≥10 mg/dL, along with an abnormal FLC ratio in patients with FLC only measurable myeloma NOTE: All attempts should be made to establish measurable disease at screening based on blood or urine central laboratory results. Under exceptional circumstances and with the sponsor’s approval, local laboratory results of blood, urine M-protein measurements, and sFLC may be used to determine measurable disease if the results are ≥25% above the thresholds for measurability. Central laboratory results are still to be obtained prior to the start of administration of study treatment as a reference for response assessment."}
{"criterion_text":"- ECOG performance status of 0, 1, or 2."}
{"criterion_text":"- Participants must have clinical laboratory values meeting the below criteria. These laboratory values must be evaluated during screening and be re-evaluated within 72 hours prior to the first dose and the patient must meet all criteria at both assessments. If one or more criteria are not met 72 hours prior to dosing, 1 repeat of laboratory testing is permitted. ANC ≥1,000 cells/mm3 (1 x 109 cells/L) without growth factor support within 7 days for G-CSF and within 14 days for pegylated-G-CSF of the lab assessment. Hemoglobin ≥7.5 g/dL (≥4.65 mmol/L) without red blood cell transfusions within 7 days of the lab assessment. Platelet counts of ≥75,000 cells/mm3 for participants who have bone marrow plasmacytosis of <50%, or ≥50,000 cells/mm3 for participants who have bone marrow plasmacytosis of ≥50%. A participant may not have received a platelet transfusion or thrombopoietin receptor agonist within 7 days of the lab assessment. Serum creatinine clearance by MDRD (Modification of Diet in Renal Disease) ≥30 mL/min. A participant with a creatinine clearance by MDRD who does not meet eligibility criteria may be considered for enrollment if a measured creatinine clearance, based on 24-hour urine collection or another reliable method is ≥30 mL/min. Total bilirubin ≤2 times the institutional upper limit of the normal values (IULN), with the exception of participants that have known or suspected Gilbert’s syndrome, (in which case direct bilirubin ≤2.0 x ULN is required). Total AST and ALT ≤3 X ULN. Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)."}
{"criterion_text":"- Be willing and able to comply with clinic visits and study-related procedures, including serial bone marrow evaluations."}
{"criterion_text":"- Be willing to be hospitalized or remain in close proximity (within 30 minutes) to the hospital at minimum after step-up dose 1 if randomized to the experimental arm."}
{"criterion_text":"- Due to the embryo-fetal risk associated with IMiDs, all participants must adhere to the global PPP or local PPP/REMS program for lenalidomide."}

Exclusion criteria

{"criterion_text":"- IMWG Frailty Index of ≥2 (i.e. frail patients) with the exception of participants who have a score of 2 and are frail based on age alone (Palumbo et al., 2015). Participants who have a frailty score of 2 based on age alone will be capped at 10% of the total study population."}
{"criterion_text":"- History of severe allergic reaction attributed to any study drug or excipient (ie, monoclonal antibodies and/or their excipients) used to treat indications other than MM. A “severe allergic reaction” is defined for this purpose as requiring hospitalization and/or treatment with epinephrine. Prior infusion reactions with monoclonal antibody-based therapeutics will not be considered evidence of an allergic reaction."}
{"criterion_text":"- Known contraindications to the use of daratumumab or lenalidomide per local prescribing information."}
{"criterion_text":"- Known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of lenalidomide (eg, gastric bypass, lap band, or other gastric procedures that would alter absorption); delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed."}
{"criterion_text":"- Participants who required plasmapheresis within 4 weeks from C1D1."}
{"criterion_text":"- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or another uncontrolled infection (such as cytomegalovirus [CMV])."}
{"criterion_text":"- Participants will be excluded if they have any of the following malignancies: Myelodysplastic syndrome or B cell malignancy (other than multiple myeloma) Any history of malignancy that is considered at high risk of recurrence requiring systemic therapy, other than multiple myeloma, • Prior or concurrent malignancy within 24 months prior to the date of randomization (other than multiple myeloma) The only allowed exceptions are malignancies adequately treated within the last 24 months that are considered cured: Non-muscle invasive bladder cancer (solitary Ta-papillary urothelial neoplasm of low malignancy or low grade, <3 cm, no carcinoma in situ) Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone Noninvasive cervical cancer Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (anti-hormonal therapy is permitted) Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (radical prostatectomy/radiation therapy/focal treatment) Other malignancy that is considered cured with minimal risk of recurrence are permitted following consultation with and approval by the sponsor’s medical monitor."}
{"criterion_text":"- Investigational, live or live attenuated, or replication-competent viral vector vaccine within 28 days prior to first study treatment."}
{"criterion_text":"- History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time."}
{"criterion_text":"- Known hypersensitivity to both allopurinol and rasburicase."}
{"criterion_text":"- Unable or unwilling to undergo antithrombotic prophylactic treatment as determined by investigator."}
{"criterion_text":"- Participants who defer transplant due to personal preference (who would otherwise be candidates for transplant based on age and absence of comorbid conditions that would preclude transplant candidacy)."}
{"criterion_text":"- Members of the clinical site study team and/or his/her immediate family, unless prior approval granted by the Sponsor."}
{"criterion_text":"- Pregnant or breastfeeding females."}
{"criterion_text":"- Females of childbearing potential (FOCBP)* or sexually active males who are unwilling to practice highly effective contraception prior C1D1, during the study, and for at least 6 months after the last dose. ... (full contraception/FOCBP policy as per protocol)."}
{"criterion_text":"- Participants with non-secretory MM, active plasma cell leukemia defined as either having 5% of peripheral white blood cells comprised of CD138+ plasma cells, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)."}
{"criterion_text":"- Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of allowed localized or short emergency/palliative treatments as specified in the protocol."}
{"criterion_text":"- Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM (or another plasma cell disorder), or those whose AEs due to agents administered earlier (such as radiation and/or corticosteroids) have not recovered to a severity of grade 0 or grade 1."}
{"criterion_text":"- Participants who have undergone any major surgery within 4 weeks prior to C1D1, with listed exceptions."}
{"criterion_text":"- Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1."}
{"criterion_text":"- Participants who have uncontrolled intercurrent illness including, but not limited to: ongoing or active viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy; active autoimmune disease (with listed exceptions); symptomatic congestive heart failure (e.g., NYHA Class III or IV); cardiac dysfunction with EF <40%; angina pectoris; uncontrolled hypertension; clinically significant arrhythmia; COPD with FEV1 <50% predicted; moderate/severe persistent or uncontrolled asthma; diabetes (HbA1c >8% in prior 6 months); significant psychiatric conditions or social situations limiting compliance."}
{"criterion_text":"- History of myocardial infarction within the previous 12 months prior to C1D1."}

Endpoints

Primary endpoints

{"endpoint_text":"- MRD negative CR status at 10-5 (as measured in BM by clonoSEQ assay) per IMWG criteria (S. Kumar et al., 2016) as determined by BICR","definition_or_measurement_approach":"MRD negative CR status measured in bone marrow using the clonoSEQ assay with sensitivity of at least 10^-5, assessed per IMWG criteria and determined by blinded independent central review (BICR)."}
{"endpoint_text":"- PFS per IMWG response criteria (S. Kumar et al., 2016) as determined by BICR, defined as the time from the date of randomization to the date of first documented evidence of progressive disease or death, whichever occurs first","definition_or_measurement_approach":"Progression-free survival (PFS) defined as time from randomization to first documented progressive disease or death per IMWG response criteria, adjudicated by blinded independent central review (BICR)."}

Secondary endpoints

{"endpoint_text":"- • The key secondary endpoint is overall survival (OS) from time of randomization.","definition_or_measurement_approach":"Overall survival (OS) measured from time of randomization to death from any cause."}

Recruitment

Planned Sample Size: 217
Recruitment Window Months: 121
Consent Approach: Informed consent must be provided in writing by the study participant ("Provide informed consent signed by study patient."). Only adults (≥18 years or legal adult age in country) are eligible. Country-specific informed consent documents and addenda are provided (local ICFs in each participating country/language as per document list), and pregnancy/contraception information and partner/withdrawal ICFs are included where applicable.

Geography

Total Number Of Sites: 62
Total Number Of Participants: 713

Croatia

Earliest CTIS Part Ii Submission Date: 25-08-2025
Latest Decision Or Authorization Date: 02-03-2026
Processing Time Days: 189
Number Of Sites: 1
Number Of Participants: 12

Sites

Site Name: University Hospital Centre Zagreb
Department Name: 191001: Hematology
Principal Investigator Name: Sandra Basic-Kinda
Principal Investigator Email: sandra.kinda@gmail.com
Contact Person Name: Sandra Basic-Kinda
Contact Person Email: sandra.kinda@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date: 21-08-2025
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 188
Number Of Sites: 5
Number Of Participants: 55

Sites

Site Name: Fakultni Nemocnice Ostrava
Department Name: 203004; Klinika hematoonkologie
Principal Investigator Name: Roman Hajek
Principal Investigator Email: roman.hajek@fno.cz
Contact Person Name: Roman Hajek
Contact Person Email: roman.hajek@fno.cz

Site Name: Fakultni Nemocnice Brno
Department Name: 203001; Int. hemat. a onkol. klinika
Principal Investigator Name: Ludek Pour
Principal Investigator Email: pour.ludek@fnbrno.cz
Contact Person Name: Ludek Pour
Contact Person Email: pour.ludek@fnbrno.cz

Site Name: University Hospital Olomouc
Department Name: 203003; Hemato-onkologicka klinika
Principal Investigator Name: Jiri Minarik
Principal Investigator Email: abretina@email.cz
Contact Person Name: Jiri Minarik
Contact Person Email: abretina@email.cz

Site Name: Fakultni Nemocnice Hradec Kralove
Department Name: 203002; IV. interni hematologicka klinika
Principal Investigator Name: Jakub Radocha
Principal Investigator Email: jakub.radocha@centrum.cz
Contact Person Name: Jakub Radocha
Contact Person Email: jakub.radocha@centrum.cz

Site Name: Fakultni Nemocnice Plzen
Department Name: 203005; Hematologicko-onkologicke odd.
Principal Investigator Name: Alexandra Jungova
Principal Investigator Email: jungovaa@fnplzen.cz
Contact Person Name: Alexandra Jungova
Contact Person Email: jungovaa@fnplzen.cz

Estonia

Earliest CTIS Part Ii Submission Date: 14-08-2025
Latest Decision Or Authorization Date: 02-03-2026
Processing Time Days: 200
Number Of Sites: 2
Number Of Participants: 28

Sites

Site Name: Tartu University Hospital
Department Name: 233001; Hematology-Oncology Clinic
Principal Investigator Name: Maris Parnat
Principal Investigator Email: Maris.Parnat@kliinikum.ee
Contact Person Name: Maris Parnat
Contact Person Email: Maris.Parnat@kliinikum.ee

Site Name: North Estonia Medical Centre Foundation
Department Name: 233002
Principal Investigator Name: Diana Loigom
Principal Investigator Email: Diana.Loigom@regionaalhaigla.ee
Contact Person Name: Diana Loigom
Contact Person Email: Diana.Loigom@regionaalhaigla.ee

Ireland

Earliest CTIS Part Ii Submission Date: 11-08-2025
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 197
Number Of Sites: 4
Number Of Participants: 60

Sites

Site Name: Beaumont Hospital
Department Name: 372004: Department of Haematology
Principal Investigator Name: John Quinn
Principal Investigator Email: johnquinn@beaumont.ie
Contact Person Name: John Quinn
Contact Person Email: johnquinn@beaumont.ie

Site Name: University Hospital Galway
Department Name: 372001: Department of Haematology
Principal Investigator Name: Jannusz Krawczyk
Principal Investigator Email: janusz.krawczyk@hse.ie
Contact Person Name: Jannusz Krawczyk
Contact Person Email: janusz.krawczyk@hse.ie

Site Name: University Hospital Limerick
Department Name: 372005: Department of Haematology
Principal Investigator Name: Ruth Clifford
Principal Investigator Email: Ruth.Clifford@ul.ie
Contact Person Name: Ruth Clifford
Contact Person Email: Ruth.Clifford@ul.ie

Site Name: Cork University Hospital
Department Name: 372002: Hematology y hemoterapy
Principal Investigator Name: Vitaliy Mykytiv
Principal Investigator Email: Vitaliy.Mykytiv@hse.ie
Contact Person Name: Vitaliy Mykytiv
Contact Person Email: Vitaliy.Mykytiv@hse.ie

Netherlands

Earliest CTIS Part Ii Submission Date: 20-08-2025
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 188
Number Of Sites: 1
Number Of Participants: 5

Sites

Site Name: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name: 528001; Hematology, Transfusion Medicine
Principal Investigator Name: Claudia Antoinette Maria Stege
Principal Investigator Email: c.stege@erasmusmc.nl
Contact Person Name: Claudia Antoinette Maria Stege
Contact Person Email: c.stege@erasmusmc.nl

Norway

Earliest CTIS Part Ii Submission Date: 19-08-2025
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 190
Number Of Sites: 4
Number Of Participants: 46

Sites

Site Name: St. Olavs Hospital HF
Department Name: 578003: Department of Blood Diseases
Principal Investigator Name: Tobias Slordahl
Principal Investigator Email: tobias.s.slordahl@ntnu.no
Contact Person Name: Tobias Slordahl
Contact Person Email: tobias.s.slordahl@ntnu.no

Site Name: Sykehuset I Vestfold HF
Department Name: 578001: Oncology
Principal Investigator Name: Magnus Moksnes
Principal Investigator Email: magmok@siv.no
Contact Person Name: Magnus Moksnes
Contact Person Email: magmok@siv.no

Site Name: Oslo University Hospital HF
Department Name: 578004: Oslo Myeloma Center
Principal Investigator Name: Fredrik Schjesvold
Principal Investigator Email: fredrikschjesvold@gmail.com
Contact Person Name: Fredrik Schjesvold
Contact Person Email: fredrikschjesvold@gmail.com

Site Name: Helse Stavanger HF
Department Name: 578002: Hematology
Principal Investigator Name: Einar Haukås
Principal Investigator Email: einar.haukas@sus.no
Contact Person Name: Einar Haukås
Contact Person Email: einar.haukas@sus.no

Denmark

Earliest CTIS Part Ii Submission Date: 14-08-2025
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 194
Number Of Sites: 2
Number Of Participants: 10

Sites

Site Name: Region Sjaelland
Department Name: #208002 : Department of Hematology
Principal Investigator Name: Trung Do
Principal Investigator Email: trhd@regionsjaelland.dk
Contact Person Name: Trung Do
Contact Person Email: trhd@regionsjaelland.dk

Site Name: Region Midtjylland
Department Name: #208001: Blodsygdomme Klinisk Forskning
Principal Investigator Name: Maja Vase
Principal Investigator Email: majavase@rm.dk
Contact Person Name: Maja Vase
Contact Person Email: majavase@rm.dk

Belgium

Earliest CTIS Part Ii Submission Date: 01-08-2025
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 207
Number Of Sites: 4
Number Of Participants: 22

Sites

Site Name: UZ Leuven
Department Name: 056001-Hematologie
Principal Investigator Name: Michel Delforge
Principal Investigator Email: Michel.delforge@uzleuven.be
Contact Person Name: Michel Delforge
Contact Person Email: Michel.delforge@uzleuven.be

Site Name: Ziekenhuis Aan De Stroom
Department Name: 056003-Hematologie
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: Ziekenhuis Aan De Stroom
Department Name: 056003-Hematologie
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: CHU Helora
Department Name: 056002-Hématologie
Principal Investigator Name: Alain Kentos
Principal Investigator Email: alain.kentos@helora.be
Contact Person Name: Alain Kentos
Contact Person Email: alain.kentos@helora.be

Finland

Earliest CTIS Part Ii Submission Date: 05-08-2025
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 203
Number Of Sites: 2
Number Of Participants: 11

Sites

Site Name: HUS-Yhtymae
Department Name: 246002-Department of hematology
Principal Investigator Name: Hannah Söderholm
Principal Investigator Email: hannah.soderholm@hus.fi
Contact Person Name: Hannah Söderholm
Contact Person Email: hannah.soderholm@hus.fi

Site Name: Kuopio University Hospital
Department Name: 246001-Oncology
Principal Investigator Name: Anu Partanen
Principal Investigator Email: anu.partanen@pshyvinvointialue.fi
Contact Person Name: Anu Partanen
Contact Person Email: anu.partanen@pshyvinvointialue.fi

Greece

Earliest CTIS Part Ii Submission Date: 29-05-2025
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 272
Number Of Sites: 4
Number Of Participants: 66

Sites

Site Name: Evangelismos S.A.
Department Name: 300003: Heamatology
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: 300002: Hematology/ Oncology Department
Principal Investigator Name: Eirini Katodritou
Principal Investigator Email: eirinikatodritou@gmail.com
Contact Person Name: Eirini Katodritou
Contact Person Email: eirinikatodritou@gmail.com

Site Name: University General Hospital Of Alexandroupoli
Department Name: 300004: Hematology
Principal Investigator Name: Emmanouil Spanoudakis
Principal Investigator Email: emmanouilspanoudakis@yahoo.com
Contact Person Name: Emmanouil Spanoudakis
Contact Person Email: emmanouilspanoudakis@yahoo.com

Site Name: Alexandra Hospital
Department Name: 300001: Clinical Therapeutics
Principal Investigator Name: Evangelos Terpos
Principal Investigator Email: eterpos@med.uoa.gr
Contact Person Name: Evangelos Terpos
Contact Person Email: eterpos@med.uoa.gr

Portugal

Earliest CTIS Part Ii Submission Date: 29-05-2025
Latest Decision Or Authorization Date: 27-02-2026
Processing Time Days: 274
Number Of Sites: 2
Number Of Participants: 45

Sites

Site Name: Unidade Local De Saude De Santo Antonio E.P.E.
Department Name: 620005; Hematologia Clinica
Principal Investigator Name: Claudia Pedrosa
Principal Investigator Email: claudiapedrosa.hematologia@chporto.min-saude.pt
Contact Person Name: Claudia Pedrosa
Contact Person Email: claudiapedrosa.hematologia@chporto.min-saude.pt

Site Name: Unidade Local De Saude De Coimbra E.P.E.
Department Name: 620001; Hematologia Clinica
Principal Investigator Name: Adriana Roque
Principal Investigator Email: 13574@ulscoimbra.min-saude.pt
Contact Person Name: Adriana Roque
Contact Person Email: 13574@ulscoimbra.min-saude.pt

Sweden

Earliest CTIS Part Ii Submission Date: 04-08-2025
Latest Decision Or Authorization Date: 27-02-2026
Processing Time Days: 207
Number Of Sites: 2
Number Of Participants: 10

Sites

Site Name: Region Oestergoetland
Department Name: 752001: Hematologiska Kliniken
Principal Investigator Name: Love Tätting
Principal Investigator Email: Love.Tatting@regionostergotland.se
Contact Person Name: Love Tätting
Contact Person Email: Love.Tatting@regionostergotland.se

Site Name: Region Skane Skanes Universitetssjukhus
Department Name: 752002: Hematologiska Kliniken
Principal Investigator Name: Konstantinos Lemonakis
Principal Investigator Email: konstantinos.lemonakis@skane.se
Contact Person Name: Konstantinos Lemonakis
Contact Person Email: konstantinos.lemonakis@skane.se

Italy

Earliest CTIS Part Ii Submission Date: 29-05-2025
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 272
Number Of Sites: 18
Number Of Participants: 270

Sites

Site Name: ASST Grande Ospedale Metropolitano Niguarda
Department Name: 380014: Ematologia
Principal Investigator Name: Anna Maria Cafro
Principal Investigator Email: annamaria.cafro@ospedaleniguarda.it
Contact Person Name: Anna Maria Cafro
Contact Person Email: annamaria.cafro@ospedaleniguarda.it

Site Name: Fondazione IRCCS Policlinico San Matteo
Department Name: 380010: SC Ematologia I
Principal Investigator Name: Silvia Mangiacavalli
Principal Investigator Email: S.Mangiacavalli@smatteo.pv.it
Contact Person Name: Silvia Mangiacavalli
Contact Person Email: S.Mangiacavalli@smatteo.pv.it

Site Name: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name: 380015: UOC di Oncoematologia
Principal Investigator Name: Fabrizio Accardi
Principal Investigator Email: accardi.fabrizio@gmail.com
Contact Person Name: Fabrizio Accardi
Contact Person Email: accardi.fabrizio@gmail.com

Site Name: Azienda Ospedaliero Universitaria Delle Marche
Department Name: 380007: Clinica di Ematologia
Principal Investigator Name: Massimo Offidani
Principal Investigator Email: massimo.offidani@ospedaliriuniti.marche.it
Contact Person Name: Massimo Offidani
Contact Person Email: massimo.offidani@ospedaliriuniti.marche.it

Site Name: Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name: 380001: SSD Clinical Trial in Oncoematologia e Mieloma Multiplo
Principal Investigator Name: Alessandra Larocca
Principal Investigator Email: alessandra.larocca@unito.it
Contact Person Name: Alessandra Larocca
Contact Person Email: alessandra.larocca@unito.it

Site Name: Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name: 380011: U.O.C. Medicina Interna Universitaria ''G. Baccelli''
Principal Investigator Name: Roberto Ria
Principal Investigator Email: Roberto.ria@uniba.it
Contact Person Name: Roberto Ria
Contact Person Email: Roberto.ria@uniba.it

Site Name: Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name: 380018: S.C. Ematologia
Principal Investigator Name: Federico Monaco
Principal Investigator Email: federico.monaco@ospedale.al.it
Contact Person Name: Federico Monaco
Contact Person Email: federico.monaco@ospedale.al.it

Site Name: IRCCS Ospedale Policlinico San Martino
Department Name: 380013: Ematologia e Terapie Cellulari
Principal Investigator Name: Sara Aquino
Principal Investigator Email: sara.aquino@hsanmartino.it
Contact Person Name: Sara Aquino
Contact Person Email: sara.aquino@hsanmartino.it

Site Name: Azienda Socio Sanitaria Territoriale Ovest Milanese
Department Name: 380019: Ematologia
Principal Investigator Name: Francesca Rezzonico
Principal Investigator Email: francesca.rezzonico@asst-ovestmi.it
Contact Person Name: Francesca Rezzonico
Contact Person Email: francesca.rezzonico@asst-ovestmi.it

Site Name: Casa Sollievo Della Sofferenza
Department Name: 380005: U.O.C. Ematologia e Centro Trapianto Cellule Staminali
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 Unita Sanitaria Locale Della Romagna
Department Name: 380021: U.O. Ematologia
Principal Investigator Name: Francesco Rotondo
Principal Investigator Email: francesco.rotondo@auslromagna.it
Contact Person Name: Francesco Rotondo
Contact Person Email: francesco.rotondo@auslromagna.it

Site Name: Azienda Sanitaria Universitaria Friuli Centrale
Department Name: 380008: Clinica Ematologica
Principal Investigator Name: Francesca Patriarca
Principal Investigator Email: francesca.patriarca@asufc.sanita.fvg.it
Contact Person Name: Francesca Patriarca
Contact Person Email: francesca.patriarca@asufc.sanita.fvg.it

Site Name: Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name: 380006: UO di Ematologia con TMO V
Principal Investigator Name: Concetta Conticello
Principal Investigator Email: ettaconticello@gmail.com
Contact Person Name: Concetta Conticello
Contact Person Email: ettaconticello@gmail.com

Site Name: Azienda Ospedaliero-Universitaria Di Padova
Department Name: 380009: UOC Ematologia
Principal Investigator Name: Renato Zambello
Principal Investigator Email: r.zambello@unipd.it
Contact Person Name: Renato Zambello
Contact Person Email: r.zambello@unipd.it

Site Name: Azienda Ospedaliero-Universitaria Careggi
Department Name: 380004: U.O.C Ematologia
Principal Investigator Name: Elisabetta Antonioli
Principal Investigator Email: antoniolie@aou-careggi.toscana.it
Contact Person Name: Elisabetta Antonioli
Contact Person Email: antoniolie@aou-careggi.toscana.it

Site Name: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name: 380017: Ematologia
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 Ospedaliera Santa Croce E Carle
Department Name: 380016: Ematologia
Principal Investigator Name: Ivana Celeghini
Principal Investigator Email: celeghini.i@ospedale.cuneo.it
Contact Person Name: Ivana Celeghini
Contact Person Email: celeghini.i@ospedale.cuneo.it

Site Name: Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name: 380002: Ematologia
Principal Investigator Name: Maria Teresa Petrucci
Principal Investigator Email: petrucci@bce.uniroma1.it
Contact Person Name: Maria Teresa Petrucci
Contact Person Email: petrucci@bce.uniroma1.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: 380003: U.O.C Ematologia
Principal Investigator Name: Elena Zamagni
Principal Investigator Email: e.zamagni@unibo.it
Contact Person Name: Elena Zamagni
Contact Person Email: e.zamagni@unibo.it

Spain

Earliest CTIS Part Ii Submission Date: 25-08-2025
Latest Decision Or Authorization Date: 02-03-2026
Processing Time Days: 190
Number Of Sites: 5
Number Of Participants: 33

Sites

Site Name: Hospital Clinic De Barcelona
Department Name: 724001; Hematología
Principal Investigator Name: Laura Rosiñol Dachs
Principal Investigator Email: lrosinol@clinic.cat
Contact Person Name: Laura Rosiñol Dachs
Contact Person Email: lrosinol@clinic.cat

Site Name: Institut Catala D'oncologia
Department Name: 724002; Hematología
Principal Investigator Name: Gladys Ibarra Fernández
Principal Investigator Email: uicico_badalona@iconcologia.net
Contact Person Name: Gladys Ibarra Fernández
Contact Person Email: uicico_badalona@iconcologia.net

Site Name: Hospital Universitario Marques De Valdecilla
Department Name: 724003; Hematología
Principal Investigator Name: Enrique María Ocio San Miguel
Principal Investigator Email: ocioem@unican.es
Contact Person Name: Enrique María Ocio San Miguel
Contact Person Email: ocioem@unican.es

Site Name: Hospital Universitario Y Politecnico La Fe
Department Name: 724004; Hematología y Hemoterapia
Principal Investigator Name: Javier De la Rubia Comos
Principal Investigator Email: delarubia_jav@gva.es
Contact Person Name: Javier De la Rubia Comos
Contact Person Email: delarubia_jav@gva.es

Site Name: Hospital Universitario 12 De Octubre
Department Name: 724005; Hematología y Hemoterapia
Principal Investigator Name: Joaquín Martínez López
Principal Investigator Email: jmarti01@med.ucm.es
Contact Person Name: Joaquín Martínez López
Contact Person Email: jmarti01@med.ucm.es

Austria

Earliest CTIS Part Ii Submission Date: 25-08-2025
Latest Decision Or Authorization Date: 26-02-2026
Processing Time Days: 186
Number Of Sites: 3
Number Of Participants: 10

Sites

Site Name: Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name: 040002: NA
Principal Investigator Name: Thomas Melchardt
Principal Investigator Email: t.melchardt@salk.at
Contact Person Name: Thomas Melchardt
Contact Person Email: t.melchardt@salk.at

Site Name: Stadt Wien Wiener Gesundheitsverbund
Department Name: 040003: Klinik Ottakring, 1. Medizinische Abteilung
Principal Investigator Name: Martin Schreder
Principal Investigator Email: Martin.schreder@gesundheitsverbund.at
Contact Person Name: Martin Schreder
Contact Person Email: Martin.schreder@gesundheitsverbund.at

Site Name: Ordensklinikum Linz GmbH
Department Name: 040001: Elisabethinen - Hämatologie, Hämostaseologie, medizinische Onkologie
Principal Investigator Name: Irene Strassl
Principal Investigator Email: Irene.strassl@ordensklinikum.at
Contact Person Name: Irene Strassl
Contact Person Email: Irene.strassl@ordensklinikum.at

Germany

Earliest CTIS Part Ii Submission Date: 19-08-2025
Latest Decision Or Authorization Date: 21-04-2026
Processing Time Days: 245
Number Of Sites: 3
Number Of Participants: 30

Sites

Site Name: Universitaetsklinikum Schleswig-Holstein AöR
Department Name: 276001; Klinik fuer Haematologie und Onkologie
Principal Investigator Name: Theo Leitner
Principal Investigator Email: Theo.Leitner@uksh.de
Contact Person Name: Theo Leitner
Contact Person Email: Theo.Leitner@uksh.de

Site Name: Universitaetsklinikum Wuerzburg AöR
Department Name: 276002; Medizinische Klinik und Poliklinik 2
Principal Investigator Name: Johannes Waldschmidt
Principal Investigator Email: Waldschmid_J@ukw.de
Contact Person Name: Johannes Waldschmidt
Contact Person Email: Waldschmid_J@ukw.de

Site Name: Universitaetsmedizin Greifswald KöR
Department Name: 276003; Klinik und Poliklinik für Innere Medizin C
Principal Investigator Name: Jan Krönke
Principal Investigator Email: jan.kroenke@med.uni-greifswald.de
Contact Person Name: Jan Krönke
Contact Person Email: jan.kroenke@med.uni-greifswald.de

Sponsor

Primary sponsor

Full Name: European Myeloma Network B.V.
Organisation Type: Patient organisation/association
Country Of Registered Address: Netherlands

Contract research organisations

Name: Parexel International (IRL) Limited
Responsibilities: codes: 1,11,12,5,6,7,8,9

Name: Excelya Greece CRO Single Member S.A.
Responsibilities: codes: 1,12

Third parties

{"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"MRD negativity status","organisation_type":"Pharmaceutical company"}
{"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"codes: 1,12","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"Fish testing","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"Italy","full_name":"Emn Trial Office S.r.l. Impresa Sociale","duties_or_roles":"Correlatives: immune cell phenotyping, gene expression and immune receptor sequencing (on BM and PB), CHIP and germline sequencing (on BM and PB), CTC enumeration, biopsy for imaging , MRD by NGF","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Regeneron Pharmaceuticals Inc.","duties_or_roles":"PK, sBCMA , cytokines, ADA","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central labs , Disease evaluation, Stockaging of BM and blood for MRD by NGS, PK , cytokines, ADA, sBCMA","organisation_type":"Pharmaceutical company"}
{"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"labeling/secondary packaging activities","organisation_type":"Pharmaceutical company"}
{"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"codes: 1,11,12,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"RTSM – treatment randomization EDC - database","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}

Co-sponsors

Emn Trial Office S.r.l. Impresa Sociale

Investigational products

Investigational Product Name: LYNOZYFIC 5 mg concentrate for solution for infusion (linvoseltamab)
Active Substance: LINVOSELTAMAB
Modality: Bispecific antibody
Routes Of Administration: SOLUTION FOR INFUSION
Route: intravenous infusion (solution for infusion)
Authorisation Status: Authorised

Investigational Product Name: LYNOZYFIC 200 mg concentrate for solution for infusion (linvoseltamab)
Active Substance: LINVOSELTAMAB
Modality: Bispecific antibody
Routes Of Administration: SOLUTION FOR INFUSION
Route: intravenous infusion (solution for infusion)
Authorisation Status: Authorised

Investigational Product Name: DARZALEX 1800 mg solution for injection
Active Substance: DARATUMUMAB
Modality: Monoclonal antibody
Routes Of Administration: SOLUTION FOR INJECTION
Route: subcutaneous / injection (per product SmPC)
Authorisation Status: Authorised
Orphan Designation: Yes
Starting Dose: 1800 mg (marketing product strength listed)

Investigational Product Name: Lenalidomide (various marketed formulations e.g., Revlimid, Lenalidomid AL, Lenalidomid STADA)
Active Substance: LENALIDOMIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Authorised
Dose Levels: various strengths available (5 mg, 10 mg, 15 mg, 25 mg listed)
Maximum Dose: 25 mg (max daily dose amount per product entries)

Investigational Product Name: Dexamethason (Dexamethason CF 20 mg/ml, Dexamethason Teva 4 mg tablets)
Active Substance: DEXAMETHASONE
Modality: Small molecule
Routes Of Administration: SOLUTION FOR INJECTION / ORAL USE
Route: oral or injectable depending on formulation
Authorisation Status: Authorised
Maximum Dose: 40 mg (max daily dose amount per product entries)

Combination Treatment: Yes

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