Clinical trial • Phase III • Oncology
ELRANATAMAB for Multiple myeloma
Phase III trial of ELRANATAMAB for Multiple myeloma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Other antibody|Small molecule|Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 04-03-2024
- First CTIS Authorization Date
- 10-04-2024
Trial design
Randomised, open-label, lenalidomide (zelvina 5 mg / 10 mg / 15 mg hard capsules) — oral comparator product(s) listed (max daily dose specified as 15 mg in product data); scheduling/dosing regimen not specified in the supplied ctis data.-controlled Phase III trial across 84 sites in Germany, Greece, Norway and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Lenalidomide (Zelvina 5 mg / 10 mg / 15 mg hard capsules) — oral comparator product(s) listed (max daily dose specified as 15 mg in product data); scheduling/dosing regimen not specified in the supplied CTIS data.
- Target Sample Size
- 383
Eligibility
Recruits 383 The record indicates 'isVulnerablePopulationSelected': true. Participants must be ≥18 years and 'Capable of giving signed informed consent' (principal inclusion criterion 13). Consent must be provided by the participant (no assent provisions for minors are provided). No further details on other vulnerable groups or assent/consent handling were specified in the supplied sources..
- Vulnerable Population
- The record indicates 'isVulnerablePopulationSelected': true. Participants must be ≥18 years and 'Capable of giving signed informed consent' (principal inclusion criterion 13). Consent must be provided by the participant (no assent provisions for minors are provided). No further details on other vulnerable groups or assent/consent handling were specified in the supplied sources.
Inclusion criteria
- {"criterion_text":"- 1. Participant’s age ≥18 years (or the minimum country specific age of consent if >18) at Visit 1 (Screening), or at the pre-screening visit, as applicable. - Male participants and female participants of childbearing potential must agree to use contraception\n- 10. Adequate post-ASCT recovery of BM function at screening and randomization as characterized by the following: - Absolute neutrophil count (ANC) ≥1.0 × 109/L (use of granulocyte colonystimulating factor [G-CSF] is permitted if completed at least 7 days prior to planned start of dosing; G-CSF should not be used to reach this level); - Platelets ≥75 × 109/L (transfusion support is permitted if completed at least 7 days prior to planned start of dosing); and - Hemoglobin ≥8 g/dL (transfusion support is permitted if completed at least 14 days prior to planned start of dosing).\n- 11. Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L).\n- 12. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.\n- 13. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.\n- 2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n- 3. Diagnosis of MM as defined according to IMWG criteria1 with measurable disease at diagnosis as defined by serum M-protein ≥0.5 g/dL (5 g/L), by urine M-protein ≥200 mg/24 hours, or by serum free light chain (FLC) assay with involved FLC level ≥10 mg/dL, provided serum FLC ratio is abnormal.\n- 4. PR or better according to IMWG criteria at the time of randomization.\n- 5. Identification of the dominant malignant (index) clone as assessed by central laboratory NGS test (Adaptive Biotechnologies clonoSEQ® assay.\n- 6. ECOG performance status ≤1.\n- 7. Left ventricular ejection fraction (LVEF) ≥40% as determined by a multigated acquisition (MUGA) scan or echocardiogram (ECHO).\n- 8. Adequate hepatic function characterized by the following: - Total bilirubin ≤2 × upper limit of normal (≤3 × ULN if documented Gilbert’s syndrome and direct bilirubin ≤ ULN); - Aspartate aminotransferase (AST) ≤2.5 × ULN; and - Alanine aminotransferase (ALT) ≤2.5 × ULN.\n- 9. Adequate renal function defined according to local institutional standard method: estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 equation or estimated creatinine clearance (CrCl) ≥30 mL/min using Cockcroft Gault formula. If both formulae are calculated, the higher of the 2 values may be used. A 24-hour urine collection for CrCl may also be used in equivocal cases where amyloidosis is suspected."}
Exclusion criteria
- {"criterion_text":"- 1. Plasma cell leukemia defined as more than 20% circulating plasma cells and an absolute count >2 × 109/L plasma cells in peripheral blood)\n- 10. Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.\n- 2. Amyloidosis, Waldenström’s macroglobulinemia, or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome.\n- 3. Known active central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement\n- 4. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment: - Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion); - Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia); - Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism); Prolonged time from the beginning of the Q wave to the end of the T wave (QT) syndrome or QT corrected using Friderica’s formula (QTcF) >470 msec at screening.\n- 5. Ongoing Grade ≥3 peripheral sensory or motor neuropathy.\n- 6. History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n- 7. Live attenuated vaccine within 4 weeks of the first dose.\n- 8. Known or suspected hypersensitivity to the study interventions or any of its excipients.\n- 9. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per the investigator."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free survival (PFS) by Blinded Independent Central Review (BICR) per International Myeloma Working Group (IMWG)","definition_or_measurement_approach":"PFS assessed by Blinded Independent Central Review (BICR) according to International Myeloma Working Group (IMWG) criteria."}
Secondary endpoints
- {"endpoint_text":"- Minimal residual disease (MRD)-negative rate at 12 months after randomization per IMWG as assessed via next-generation sequencing (NGS)","definition_or_measurement_approach":"MRD-negativity assessed at 12 months after randomization per IMWG using next-generation sequencing (NGS; Adaptive Biotechnologies clonoSEQ® assay)."}
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomization to death (no further specification provided in the supplied record)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 383
- Recruitment Window Months
- 90
- Consent Approach
- Informed consent must be provided as signed consent by the participant (inclusion criterion: 'Capable of giving signed informed consent'). Participants are adults (≥18 years). Country-specific subject information and informed consent forms (ICD/ICF) and pre-screening consent documents are available in multiple languages (document titles indicate EN, DE, GR, NO, FR, PL, ES, IT, SE, FI, HU, CZ, NL versions). Electronic consent/eCOA capability is referenced via a third-party role (Signant Health Global LLC responsible for eCOA/electronic consent). No assent procedures for minors are provided (trial limited to adults).
Methods
- Program-level brochure (MagnetisMM) — patient-facing printed material (country-specific versions documented e.g. DE, AT).
- Clinic posters and study flyers — site-based printed recruitment materials (multiple country versions present).
- Patient Study Intro Letters and Physician Letters — outreach via clinicians (country-specific templates present).
- Referral outreach PowerPoint — materials for referral networks and clinicians.
- Homepage / ProgramStudyPage / ClinicalTrialTiles — online/digital study webpages and program pages (country-specific versions documented).
- General FAQs and Privacy notices — online information and privacy statements for prospective participants.
- Patient-facing cards (e.g. Infection Risk Management card) — handouts for participants.
- Pre-screening and prescreen ICD forms and PPRIF documents — pre-screen consent/information materials (country-specific).
- Materials exist in country/language-specific packages (e.g., DE, AT, GR, NO, BE, ES, PL, FR, IT, SE, FI, HU, CZ, NL).
Geography
- Total Number Of Sites
- 84
- Total Number Of Participants
- 383
Germany
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 17-04-2024
- Processing Time Days
- 30
- Number Of Sites
- 7
- Number Of Participants
- 25
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Hämatologie-Onkologie-Tumorimmunologie CC14 Campus Benjamin Franklin
- Principal Investigator Name
- Stephan Bohl
- Principal Investigator Email
- Stephan.Bohl@charite.de
- Contact Person Name
- Stephan Bohl
- Contact Person Email
- Stephan.Bohl@charite.de
- Site Name
- Poliklinik gGmbH Chemnitz
- Department Name
- Klinik für Innere Medizin III
- Principal Investigator Name
- Mathias Hänel
- Principal Investigator Email
- m.haenel@skc.de
- Contact Person Name
- Mathias Hänel
- Contact Person Email
- m.haenel@skc.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Zentrum für klinische Studien der Klinik und Poliklinik für Innere Medizin III
- Principal Investigator Name
- Florian Bassermann
- Principal Investigator Email
- florian.bassermann@tum.de
- Contact Person Name
- Florian Bassermann
- Contact Person Email
- florian.bassermann@tum.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- III. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Christian Michel
- Principal Investigator Email
- christian.michel@unimedizin-mainz.de
- Contact Person Name
- Christian Michel
- Contact Person Email
- christian.michel@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Hämatologie und Stammzelltransplantation
- Principal Investigator Name
- Amelie Boquoi
- Principal Investigator Email
- Amelie.boquoi@uk-essen.de
- Contact Person Name
- Amelie Boquoi
- Contact Person Email
- Amelie.boquoi@uk-essen.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
- Principal Investigator Name
- Simone Heyn
- Principal Investigator Email
- simone.heyn@medizin.uni-leipzig.de
- Contact Person Name
- Simone Heyn
- Contact Person Email
- simone.heyn@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Martin Kortüm
- Principal Investigator Email
- kortuem_m@ukw.de
- Contact Person Name
- Martin Kortüm
- Contact Person Email
- kortuem_m@ukw.de
Greece
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 28-06-2024
- Processing Time Days
- 7
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Alexandra Hospital
- Department Name
- GENERAL HOSPITAL OF ATHENS ALEXANDRA Therapeutic Clinic
- Principal Investigator Name
- Meletios Dimopoulos
- Principal Investigator Email
- mdimop@med.uoa.gr
- Contact Person Name
- Meletios Dimopoulos
- Contact Person Email
- mdimop@med.uoa.gr
- Site Name
- Theageneio Cancer Hospital
- Department Name
- THEAGENIO Cancer Hospital of Thessaloniki, Hematology 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 Ioannina
- Department Name
- Department of Haematology, University General Hospital of Ioannina, Ioannina, hematologyDepartment
- Principal Investigator Name
- Eleftheria Hatzimichael
- Principal Investigator Email
- ehatzim@uoi.gr
- Contact Person Name
- Eleftheria Hatzimichael
- Contact Person Email
- ehatzim@uoi.gr
Norway
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 24
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Oslo myelomatosesenter
- 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
- Principal Investigator Name
- Kari Lenita Falck Moore
- Principal Investigator Email
- kari.lenita.falck.moore@sus.no
- Contact Person Name
- Kari Lenita Falck Moore
- Contact Person Email
- kari.lenita.falck.moore@sus.no
Belgium
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 18-04-2024
- Processing Time Days
- 31
- Number Of Sites
- 6
- Number Of Participants
- 22
Sites
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Oncology & Hematology
- Principal Investigator Name
- Geraldine Verstraete
- Principal Investigator Email
- geraldine.verstraete@ghdc.be
- Contact Person Name
- Geraldine Verstraete
- Contact Person Email
- geraldine.verstraete@ghdc.be
- Site Name
- UZ Brussel
- Department Name
- Medical Oncology and Hematology
- Principal Investigator Name
- Henri Schots
- Principal Investigator Email
- rik.schots@uzbrussel.be
- Contact Person Name
- Henri Schots
- Contact Person Email
- rik.schots@uzbrussel.be
- Site Name
- Universiteit Gent
- Department Name
- Hematology
- Principal Investigator Name
- Nicolas Kint
- Principal Investigator Email
- nicolas.kint@uzgent.be
- Contact Person Name
- Nicolas Kint
- Contact Person Email
- nicolas.kint@uzgent.be
- Site Name
- Institut Jules Bordet
- Department Name
- Hematology
- Principal Investigator Name
- Julie Dallemagne
- Principal Investigator Email
- julie.dallemagne@erasme.ulb.ac.be
- Contact Person Name
- Julie Dallemagne
- Contact Person Email
- julie.dallemagne@erasme.ulb.ac.be
- Site Name
- Het Ziekenhuisnetwerk Antwerpen
- Principal Investigator Name
- Ka Lung Wu
- Principal Investigator Email
- kalung.wu@zna.be
- Contact Person Name
- Ka Lung Wu
- Contact Person Email
- kalung.wu@zna.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Hematology
- Principal Investigator Name
- Julien Depaus
- Principal Investigator Email
- julien.depaus@uclouvain.be
- Contact Person Name
- Julien Depaus
- Contact Person Email
- julien.depaus@uclouvain.be
Spain
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 10-04-2024
- Processing Time Days
- 23
- Number Of Sites
- 17
- Number Of Participants
- 70
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Principal Investigator Name
- Cristina Encinas Rodriguez
- Principal Investigator Email
- crisenro@hotmail.com
- Contact Person Name
- Cristina Encinas Rodriguez
- Contact Person Email
- crisenro@hotmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Servicio de Hematología
- Principal Investigator Name
- Adrian Alegre Amor
- Principal Investigator Email
- adrian.alegre@telefonica.net
- Contact Person Name
- Adrian Alegre Amor
- Contact Person Email
- adrian.alegre@telefonica.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Servicio de Hematologia
- Principal Investigator Name
- Luis Felipe Casado Montero
- Principal Investigator Email
- lfcasado@hmhospitales.com
- Contact Person Name
- Luis Felipe Casado Montero
- Contact Person Email
- lfcasado@hmhospitales.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- ICHMO- Clinic Institut of Haematological and Oncological diseases
- Principal Investigator Name
- Carlos José Fernández de Larrea Rodríguez
- Principal Investigator Email
- cfernan1@clinic.cat
- Contact Person Name
- Carlos José Fernández de Larrea Rodríguez
- Contact Person Email
- cfernan1@clinic.cat
- Site Name
- Institut Catala D'oncologia
- Department Name
- Servicio de Hematología
- 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
- Ed Consultas Externas planta 8. Serv Hematologia
- 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
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Hematología Clínica
- Principal Investigator Name
- Yolanda Gonzalez Montes
- Principal Investigator Email
- ygonzalez@iconcologia.net
- Contact Person Name
- Yolanda Gonzalez Montes
- Contact Person Email
- ygonzalez@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hemathology and hemotherapy
- 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 San Pedro de Alcantara
- Department Name
- Servicio de Hematología. Ensayos Clínicos.
- Principal Investigator Name
- Ignacio Casas Aviles
- Principal Investigator Email
- javier.moriano@salud-juntaex.es
- Contact Person Name
- Ignacio Casas Aviles
- Contact Person Email
- javier.moriano@salud-juntaex.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematología y Hemoterapia
- Principal Investigator Name
- Javier De La Rubia
- Principal Investigator Email
- delarubia_jav@gva.es
- Contact Person Name
- Javier De La Rubia
- Contact Person Email
- delarubia_jav@gva.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- 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
- Hospital Universitario La Paz
- Department Name
- Servicio de Hematología. Ensayos Clínicos.
- Principal Investigator Name
- Teresa de Soto Alvarez
- Principal Investigator Email
- teresa.desoto@salud.madrid.org
- Contact Person Name
- Teresa de Soto Alvarez
- Contact Person Email
- teresa.desoto@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Principal Investigator Name
- Mercedes Gironella
- Principal Investigator Email
- mgironel@vhebron.net
- Contact Person Name
- Mercedes Gironella
- Contact Person Email
- mgironel@vhebron.net
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Servicio de Hematología
- 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
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Principal Investigator Name
- Josep Maria Marti Tutusaus
- Principal Investigator Email
- jmarti@mutuaterrassa.es
- Contact Person Name
- Josep Maria Marti Tutusaus
- Contact Person Email
- jmarti@mutuaterrassa.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Planta Primera - Institut Josep Carreras
- 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 Quironsalud Madrid
- Principal Investigator Name
- Aranzazu Alonso Alonso
- Principal Investigator Email
- arancha.alonso.alonso@gmail.com
- Contact Person Name
- Aranzazu Alonso Alonso
- Contact Person Email
- arancha.alonso.alonso@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 12-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 7
- Number Of Participants
- 29
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Monika Szarejko
- Principal Investigator Email
- monasza1@gumed.edu.pl
- Contact Person Name
- Monika Szarejko
- Contact Person Email
- monasza1@gumed.edu.pl
- Site Name
- Pratia Hematologia Sp. z o.o.
- Principal Investigator Name
- Sebastian Grosicki
- Principal Investigator Email
- sgrosicki@wp.pl
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- sgrosicki@wp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Dominik Dytfeld
- Principal Investigator Email
- dytfeld@me.com
- Contact Person Name
- Dominik Dytfeld
- Contact Person Email
- dytfeld@me.com
- 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
- wrobeltw@gmail.com
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- wrobeltw@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
- Principal Investigator Name
- Krzysztof Jamroziak
- Principal Investigator Email
- k.m.jamroziak@gmail.com
- Contact Person Name
- Krzysztof Jamroziak
- Contact Person Email
- k.m.jamroziak@gmail.com
- Site Name
- Pratia S.A.
- Department Name
- Centrum Medyczne Pratia Poznań
- Principal Investigator Name
- Łukasz Pruchniewski
- Principal Investigator Email
- lukasz.pruchniewski@partia.com
- Contact Person Name
- Łukasz Pruchniewski
- Contact Person Email
- lukasz.pruchniewski@partia.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworow Ukladu Chlonnego
- Principal Investigator Name
- Joanna Romejko-Jarosińska
- Principal Investigator Email
- joanna.romejko-jarosinska@pib-nio.pl
- Contact Person Name
- Joanna Romejko-Jarosińska
- Contact Person Email
- joanna.romejko-jarosinska@pib-nio.pl
France
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 10-04-2024
- Processing Time Days
- 23
- Number Of Sites
- 9
- Number Of Participants
- 33
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Department of Hematology
- Principal Investigator Name
- Alina Danu
- Principal Investigator Email
- alina.danu@gustaveroussy.fr
- Contact Person Name
- Alina Danu
- Contact Person Email
- alina.danu@gustaveroussy.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Service d'hématologie et de thérapie cellulaire
- Principal Investigator Name
- Mohamad MOHTY
- Principal Investigator Email
- mohamad.mohty@inserm.fr
- Contact Person Name
- Mohamad MOHTY
- Contact Person Email
- mohamad.mohty@inserm.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Centre régional de Cancérologie Henry Kaplan – Service d'hématologie et thérapie cellulaire
- 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 Lille
- Department Name
- Service Maladies du sang
- 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 Lyon Sud
- Department Name
- Service d'Hématologie Clinique
- 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 Universitaire De Poitiers
- Department Name
- Pôle régional de Cancérologie, Service d'hématologie et thérapie cellulaire
- 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
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Department of Hematology
- Principal Investigator Name
- Clara Mariette
- Principal Investigator Email
- cmariette@chu-grenoble.fr
- Contact Person Name
- Clara Mariette
- Contact Person Email
- cmariette@chu-grenoble.fr
- Site Name
- Hopital Universitaire Pitie Salpetriere
- Department Name
- Service d'hématologie
- Principal Investigator Name
- Laurent GARDERET
- Principal Investigator Email
- Laurent.garderet@aphp.fr
- Contact Person Name
- Laurent GARDERET
- Contact Person Email
- Laurent.garderet@aphp.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Service d'hématologie
- 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
Italy
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 22-04-2024
- Processing Time Days
- 35
- Number Of Sites
- 8
- Number Of Participants
- 35
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- U.O.C Ematologia
- Principal Investigator Name
- Matteo Claudio Da Via'
- Principal Investigator Email
- matteo.davia@policlinico.mi.it
- Contact Person Name
- Matteo Claudio Da Via'
- Contact Person Email
- matteo.davia@policlinico.mi.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Medica
- 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 Universitaria Senese
- Department Name
- UOC Ematologia
- Principal Investigator Name
- Monica Bocchia
- Principal Investigator Email
- monica.bocchia@unisi.it
- Contact Person Name
- Monica Bocchia
- Contact Person Email
- monica.bocchia@unisi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia
- Principal Investigator Name
- Valerio De stefano
- Principal Investigator Email
- valerio.destefano@unicatt.it
- Contact Person Name
- Valerio De stefano
- Contact Person Email
- valerio.destefano@unicatt.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Clinica Ematologica
- 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 Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- UOC Ematologia
- Principal Investigator Name
- Francesco Di Raimondo
- Principal Investigator Email
- diraimon@unict.it
- Contact Person Name
- Francesco Di Raimondo
- Contact Person Email
- diraimon@unict.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Istituto di Ematologia "L. e A. Seragnoli"
- Principal Investigator Name
- Elena Zamagni
- Principal Investigator Email
- e.zamagni@unibo.it
- Contact Person Name
- Elena Zamagni
- Contact Person Email
- e.zamagni@unibo.it
- Site Name
- Universita' Degli Studi Di Roma La Sapienza
- Department Name
- Dipartimento di medicina traslazionale e di precisione
- Principal Investigator Name
- Maurizio Martelli
- Principal Investigator Email
- principalinvestigatormartelli.dmtp@uniroma1.it
- Contact Person Name
- Maurizio Martelli
- Contact Person Email
- principalinvestigatormartelli.dmtp@uniroma1.it
Sweden
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 24
- Number Of Sites
- 7
- Number Of Participants
- 25
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Hematologi
- Principal Investigator Name
- Katarina Uttervall
- Principal Investigator Email
- katarina.uttervall@regionstockholm.se
- Contact Person Name
- Katarina Uttervall
- Contact Person Email
- katarina.uttervall@regionstockholm.se
- Site Name
- Linkoping University Hospital Region Ostergotland
- Department Name
- Hematologi
- 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 Helsingborg Hospital
- Department Name
- Hematologimottagningen
- Principal Investigator Name
- Per Axelsson
- Principal Investigator Email
- per.axelsson@skane.se
- Contact Person Name
- Per Axelsson
- Contact Person Email
- per.axelsson@skane.se
- Site Name
- Region Dalarna
- Department Name
- Hematologi
- Principal Investigator Name
- Max Flogegård
- Principal Investigator Email
- Max.Flogegard@regiondalarna.se
- Contact Person Name
- Max Flogegård
- Contact Person Email
- Max.Flogegard@regiondalarna.se
- Site Name
- Sodra Alvsborg Hospital-Vastra Gotalandsregionen
- Department Name
- Hematologsektionen
- Principal Investigator Name
- Ulf Henrik Mellqvist
- Principal Investigator Email
- ulf-henrik.mellqvist@vgregion.se
- Contact Person Name
- Ulf Henrik Mellqvist
- Contact Person Email
- ulf-henrik.mellqvist@vgregion.se
- Site Name
- Region Oerebro Laen
- Department Name
- Medicinska kliniken
- Principal Investigator Name
- Jacob Crafoord
- Principal Investigator Email
- jacob.crafoord@regionorebrolan.se
- Contact Person Name
- Jacob Crafoord
- Contact Person Email
- jacob.crafoord@regionorebrolan.se
- Site Name
- Region Skane (another site listed)
- Department Name
- Hematologimottagningen
- Principal Investigator Name
- Per Axelsson
- Principal Investigator Email
- per.axelsson@skane.se
- Contact Person Name
- Per Axelsson
- Contact Person Email
- per.axelsson@skane.se
Austria
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 15-04-2024
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Medical University of Vienna
- Department Name
- University Department of Internal Medicine I, Division of Hematology and Hemostaseology
- Principal Investigator Name
- Maria-Theresa Krauth
- Principal Investigator Email
- maria.krauth@meduniwien.ac.at
- Contact Person Name
- Maria-Theresa Krauth
- Contact Person Email
- maria.krauth@meduniwien.ac.at
- Site Name
- Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
- Department Name
- Medical department
- Principal Investigator Name
- Michael Fillitz
- Principal Investigator Email
- michael.fillitz@oegk.at
- Contact Person Name
- Michael Fillitz
- Contact Person Email
- michael.fillitz@oegk.at
Netherlands
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 12-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Haga Hospital
- Department Name
- Hematology
- Principal Investigator Name
- Paula frouke Ypma
- Principal Investigator Email
- p.ypma@hagaziekenhuis.n
- Contact Person Name
- Paula frouke Ypma
- Contact Person Email
- p.ypma@hagaziekenhuis.n
- Site Name
- Isala Klinieken Stichting
- Department Name
- Oncology
- Principal Investigator Name
- Paul Geerts
- Principal Investigator Email
- p.a.f.geerts@isala.nl
- Contact Person Name
- Paul Geerts
- Contact Person Email
- p.a.f.geerts@isala.nl
- Site Name
- Universiteit Maastricht
- Principal Investigator Name
- Janine Van Elssen
- Principal Investigator Email
- janine.van.elssen@mumc.n
- Contact Person Name
- Janine Van Elssen
- Contact Person Email
- janine.van.elssen@mumc.n
Finland
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 24
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Oulu University Hospital
- Department Name
- Hematology
- Principal Investigator Name
- Marjaana Saily
- Principal Investigator Email
- marjaana.saily@pohde.fi
- Contact Person Name
- Marjaana Saily
- Contact Person Email
- marjaana.saily@pohde.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Comprehensive Cancer Center
- Principal Investigator Name
- Juha Lievonen
- Principal Investigator Email
- juha.lievonen@hus.fi
- Contact Person Name
- Juha Lievonen
- Contact Person Email
- juha.lievonen@hus.fi
- Site Name
- Turku University Hospital
- Department Name
- Hematology
- Principal Investigator Name
- Mervi Putkonen
- Principal Investigator Email
- mervi.putkonen@varha.fi
- Contact Person Name
- Mervi Putkonen
- Contact Person Email
- mervi.putkonen@varha.fi
Hungary
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 86
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- University Of Debrecen
- Department Name
- Belgyógyászati Klinika (Haematológia)
- Principal Investigator Name
- Arpad Illes
- Principal Investigator Email
- illesarpaddr@gmail.com
- Contact Person Name
- Arpad Illes
- Contact Person Email
- illesarpaddr@gmail.com
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Department Name
- Haematológiai osztály
- Principal Investigator Name
- Peter Rajnics
- Principal Investigator Email
- rajnicsp@hotmail.com
- Contact Person Name
- Peter Rajnics
- Contact Person Email
- rajnicsp@hotmail.com
- Site Name
- Semmelweis University
- Department Name
- Belgyógyászati és Hematológiai Klinika
- Principal Investigator Name
- Gergely Varga
- Principal Investigator Email
- vargager@gmail.com
- Contact Person Name
- Gergely Varga
- Contact Person Email
- vargager@gmail.com
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Hematológiai és Őssejt-transzplantációs Osztály
- Principal Investigator Name
- Zsuzsanna SZEMLAKY
- Principal Investigator Email
- szemlaky.zsuzsanna@dpckorhaz.hu
- Contact Person Name
- Zsuzsanna SZEMLAKY
- Contact Person Email
- szemlaky.zsuzsanna@dpckorhaz.hu
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
- Department Name
- Haematológiai Osztály
- Principal Investigator Name
- Laszlo Rejto
- Principal Investigator Email
- dr.rejto.laszlo@szszbmk.hu
- Contact Person Name
- Laszlo Rejto
- Contact Person Email
- dr.rejto.laszlo@szszbmk.hu
Czechia
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 24
- Number Of Sites
- 5
- Number Of Participants
- 55
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Interní klinika – klinika hematologie
- Principal Investigator Name
- Ivan Špička
- Principal Investigator Email
- spicka@cesnet.cz
- Contact Person Name
- Ivan Špička
- Contact Person Email
- spicka@cesnet.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
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Principal Investigator Name
- Tereza Popkova
- Principal Investigator Email
- tereza.popkova@fno.cz
- Contact Person Name
- Tereza Popkova
- Contact Person Email
- tereza.popkova@fno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- 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
- University Hospital Olomouc
- Department Name
- Hemato-onkologická klinika
- Principal Investigator Name
- Jiří Minařík
- Principal Investigator Email
- Jiri.Minarik2@fnol.cz
- Contact Person Name
- Jiří Minařík
- Contact Person Email
- Jiri.Minarik2@fnol.cz
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Name
- Icon Clinical Research Limited
- Name
- Parexel International (IRL) Limited
- Name
- Syneos Health Ba Limited
- Name
- Premier Research Group S.L.
Third parties
- {"country":"Canada","full_name":"Clinical Logistics Inc.","duties_or_roles":"Kit supplies and sample shipment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA (electronic consent)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"CT/MRI centralization","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Syneos Health Ba Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Bulgaria","full_name":"C3i Europe EOOD","duties_or_roles":"Medical escalation and unblinding","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Premier Research Group S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Storage for Retained Research -Prep-D1 sample","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ELRANATAMAB
- Active Substance
- ELRANATAMAB
- Modality
- Other antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Investigational product / no marketing authorisation (prodAuthStatus 1)
- Orphan Designation
- Yes
- Maximum Dose
- 76 mg (maxDailyDoseAmount 76 mg)
- Investigational Product Name
- Zelvina 15 mg hard capsules
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (prodAuthStatus 2)
- Maximum Dose
- 15 mg (maxDailyDoseAmount 15 mg)
- Investigational Product Name
- Zelvina 10 mg hard capsules
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (prodAuthStatus 2)
- Maximum Dose
- 15 mg (maxDailyDoseAmount 15 mg)
- Investigational Product Name
- Zelvina 5 mg hard capsules
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (prodAuthStatus 2)
- Maximum Dose
- 15 mg (maxDailyDoseAmount 15 mg)
- Investigational Product Name
- Privigen 100 mg/ml solution for infusion
- Active Substance
- HUMAN NORMAL IMMUNOGLOBULIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Marketing authorisation (prodAuthStatus 2)
- Maximum Dose
- 4.8 ml (maxDailyDoseAmount 4.8 ml)
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