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
Bispecific antibody|Monoclonal antibody|Small molecule|Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
28-06-2024
First CTIS Authorization Date
31-07-2024

Trial design

Randomised, open-label, arm a (edr): elranatamab (elranatamab) subcutaneous (max reported dose 76 mg) + daratumumab (darzalex 1800 mg, subcutaneous) + lenalidomide (zelvina up to 25 mg oral). arm b (d-vrd): daratumumab (darzalex 1800 mg, subcutaneous) + bortezomib (velcade 1.3 mg/m2, subcutaneous) + lenalidomide (zelvina up to 25 mg oral) + dexamethasone (various licensed tablet formulations, up to 40 mg oral). dose schedules not fully specified in the available ctis fields.-controlled, adaptive Phase III trial in Greece, France, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A (EDR): Elranatamab (ELRANATAMAB) subcutaneous (max reported dose 76 mg) + Daratumumab (DARZALEX 1800 mg, subcutaneous) + Lenalidomide (Zelvina up to 25 mg oral). Arm B (D-VRd): Daratumumab (DARZALEX 1800 mg, subcutaneous) + Bortezomib (VELCADE 1.3 mg/m2, subcutaneous) + Lenalidomide (Zelvina up to 25 mg oral) + Dexamethasone (various licensed tablet formulations, up to 40 mg oral). Dose schedules not fully specified in the available CTIS fields.
Adaptive
True, Part 1 is a dose-escalation assessment to select an RP3D based on dose-limiting toxicities (DLTs); protocol references priming/two-step up doses and a specified DLT observation window (including a specific DL F full dose at 76 mg).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
616

Eligibility

Recruits 616 Vulnerable population flag selected in CTIS (isVulnerablePopulationSelected = true). Participants are adults (age ≥18 years) and consent is obtained via subject information and informed consent forms (Main ICD / ICF documents and country-specific ICFs listed in the submission). Country-specific informed consent and prescreening consent documents are provided; no paediatric assent procedures are described in the available documentation..

Vulnerable Population
Vulnerable population flag selected in CTIS (isVulnerablePopulationSelected = true). Participants are adults (age ≥18 years) and consent is obtained via subject information and informed consent forms (Main ICD / ICF documents and country-specific ICFs listed in the submission). Country-specific informed consent and prescreening consent documents are provided; no paediatric assent procedures are described in the available documentation.

Inclusion criteria

  • {"criterion_text":"- Participants must meet the following inclusion criteria to be eligible for enrollment into the study. Criteria are for both Part 1 and Part 2 unless otherwise specified: Age and Sex:Participant's age ≥18 years (or the minimum country specific age of consent if >18) at Visit 1 (Screening)."}
  • {"criterion_text":"- •\tPart 2 only: Participant has NDMM and is transplant-ineligible. In Part 2, transplant-ineligible is defined as: •\tParticipants not considered candidates for high-dose chemotherapy and ASCT due to age or •\tParticipants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status ≤2."}
  • {"criterion_text":"- Adequate hepatic, renal, and bone marrow (BM) function (absolute neutrophil count [ANC], platelet count, hemoglobin)."}
  • {"criterion_text":"- Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)."}
  • {"criterion_text":"- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1."}
  • {"criterion_text":"- Type of Participant and Disease Characteristics: Diagnosis of multiple myeloma (MM) as defined according to IMWG criteria."}
  • {"criterion_text":"- Measurable disease based on IMWG criteria as defined by at least 1 of the following (as assessed by the central laboratory for Part 2)"}
  • {"criterion_text":"- Serum M-protein ≥0.5 g/dL (Part 1) and ≥1g/dL (Part 2)"}
  • {"criterion_text":"- Involved free light chain (FLC) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)."}
  • {"criterion_text":"- Part 1 only: Participant with NDMM or RRMM. NDMM participant must be transplant-ineligible. In Part 1 transplant-ineligible is defined by age ≥65 years or by age <65 years with comorbidities impacting the possibility of transplant. Participants with RRMM must have received 1-2 prior lines of MM therapy including at least one immunomodulatory drug (IMiD) and one proteasome inhibitor (PI)."}

Exclusion criteria

  • {"criterion_text":"- Medical Conditions: Smoldering MM."}
  • {"criterion_text":"- 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 investigator."}
  • {"criterion_text":"- Participants with known or suspected hypersensitivity to the study interventions or any of their excipients."}
  • {"criterion_text":"- Participants with known or suspected central nervous system (CNS) or clinical signs of myelomatous meningeal involvement."}
  • {"criterion_text":"- Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study."}
  • {"criterion_text":"- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery that may significantly alter the absorption of oral drugs. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed (assuming no drug interaction potential)."}
  • {"criterion_text":"- Monoclonal gammopathy of undetermined significance (MGUS)."}
  • {"criterion_text":"- Plasma cell leukemia."}
  • {"criterion_text":"- Waldenström`s Macroglobulinemia."}
  • {"criterion_text":"- Systemic light chain amyloidosis."}
  • {"criterion_text":"- Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin abnormalities (POEMS) Syndrome."}
  • {"criterion_text":"- Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment."}
  • {"criterion_text":"- •\tOngoing Grade 3 (Part 1)/Grade 2 (Part 2) or higher peripheral sensory or motor neuropathy, history of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade >3 (Part 1)/Grade >2 (Part 2) peripheral motor polyneuropathy."}
  • {"criterion_text":"- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) coronavirus disease 2019 (COVID-19)/severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. Active infections must be resolved at least 21 days prior to enrollment. Participants treated with systemic therapeutic anti-infective agents within 28 days prior to enrollment are not eligible. Prophylactic use of systemic anti-infective agents is permitted."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part 1: DLTs during the DLT observation period:For all dose levels (DLs) except DL F: From the first priming dose of elranatamab in the 2 Step-up Priming Dose Period until 28 days (± visit windows) from the first administration of the EDR combination.","definition_or_measurement_approach":"Dose-limiting toxicities (DLTs) observed during the specified DLT observation period (timeframe defined from first priming dose through 28 days ± visit windows)."}
  • {"endpoint_text":"- For DL F: 28 days (± visit windows) from the day of the first full dose of elranatamab (76 mg) in combination with daratumumab (D) and lenalidomide (R.).","definition_or_measurement_approach":"DLT observation window for dose level F: 28 days ± visit windows from the first full dose (76 mg) of elranatamab in combination with D and R."}
  • {"endpoint_text":"- Part 2: MRD negative CR rate (central lab) at 12 months after randomization per IMWG as assessed via next generation sequencing (NGS)","definition_or_measurement_approach":"Rate of complete responses that are MRD-negative as assessed by central laboratory using next generation sequencing (NGS) at 12 months post-randomization according to IMWG criteria."}
  • {"endpoint_text":"- PFS per IMWG","definition_or_measurement_approach":"Progression-free survival assessed per International Myeloma Working Group (IMWG) criteria."}

Secondary endpoints

  • {"endpoint_text":"- Part 1: Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), timing, seriousness, and relationship to study treatment. Severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.","definition_or_measurement_approach":"Adverse events characterised by type, frequency, severity (NCI CTCAE v5.0), timing, seriousness and relationship to study treatment; CRS and ICANS graded per ASTCT criteria."}
  • {"endpoint_text":"- Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing.","definition_or_measurement_approach":"Laboratory test abnormalities classified by type, frequency, timing and severity graded per NCI CTCAE v5.0."}
  • {"endpoint_text":"- Objective response rate (ORR) and complete response rate (CRR,), per International Myeloma Working Group (IMWG) response criteria as determined by investigator.","definition_or_measurement_approach":"ORR and CRR assessed per IMWG response criteria as determined by investigator."}
  • {"endpoint_text":"- Time to event endpoints: time to response (TTR, ), duration of response (DOR, ), duration of complete response (DOCR) and progression-free survival (PFS) per IMWG response criteria as determined by investigator, and overall survival (OS;);","definition_or_measurement_approach":"Time-to-event endpoints (TTR, DOR, DOCR, PFS) per IMWG criteria as determined by investigator; overall survival measured from randomization to death."}
  • {"endpoint_text":"- •\tMinimal residual disease (MRD) negative CR rate (central laboratory) per IMWG sequencing criteria.","definition_or_measurement_approach":"MRD-negative complete response rate assessed in central laboratory using IMWG sequencing criteria."}
  • {"endpoint_text":"- Predose and post dose concentrations of elranatamab against elranatamab","definition_or_measurement_approach":"Pharmacokinetic measurements: predose and post-dose serum concentrations of elranatamab."}
  • {"endpoint_text":"- Anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against elranatamab","definition_or_measurement_approach":"Assessment of immunogenicity: presence of ADAs and NAbs to elranatamab."}
  • {"endpoint_text":"- Predose concentrations of daratumumab and lenalidomide","definition_or_measurement_approach":"Predose (trough) concentration measurements for daratumumab and lenalidomide."}
  • {"endpoint_text":"- Part 2 Key Secondary: OS","definition_or_measurement_approach":"Overall survival measured in Part 2 (time from randomization to death from any cause)."}
  • {"endpoint_text":"- Secondary: Overall MRD negative CR rate per IMWG","definition_or_measurement_approach":"Overall MRD-negative CR rate according to IMWG criteria."}
  • {"endpoint_text":"- Duration of MRD negative CR per IMWG","definition_or_measurement_approach":"Duration of MRD-negative complete response per IMWG criteria."}
  • {"endpoint_text":"- PFS and progression-free survival on next line of therapy (PFS2) by investigator per IMWG","definition_or_measurement_approach":"PFS and PFS2 assessed by investigator using IMWG criteria."}
  • {"endpoint_text":"- ORR, CRR, TTR, DOR, and DOCR per IMWG","definition_or_measurement_approach":"Objective and timing/ duration response endpoints (ORR, CRR, TTR, DOR, DOCR) per IMWG criteria."}
  • {"endpoint_text":"- AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study treatment. The severity of CRS and ICANS will be graded according to ASTCT criteria (Lee, 2019).","definition_or_measurement_approach":"Adverse events characterised as above; CRS and ICANS graded per ASTCT criteria."}
  • {"endpoint_text":"- Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing.","definition_or_measurement_approach":"Laboratory abnormalities characterised by type, frequency, severity (NCI CTCAE v5.0) and timing."}
  • {"endpoint_text":"- Predose and post dose concentrations of elranatamab.","definition_or_measurement_approach":"PK sampling for elranatamab predose and post-dose concentrations."}
  • {"endpoint_text":"- ADAs and NAbs against elranatamab.","definition_or_measurement_approach":"Assessment of anti-drug antibodies and neutralizing antibodies to elranatamab."}
  • {"endpoint_text":"- EORTC QLQ-C30 and MY20European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC30) and Myeloma Module 20 (MY20).","definition_or_measurement_approach":"Patient-reported outcomes measured using EORTC QLQ-C30 and myeloma-specific MY20 module."}

Recruitment

Digital Remote Recruitment
True, materials and procedures include website/homepage program pages, digital video postcards, digital brochure inserts, and pre-screening activities via third parties (e.g. Massive Bio pre-screening) and references to digital platforms (e.g. materials referencing ThreeWire/use of platforms in recruitment documents).
Planned Sample Size
616
Recruitment Window Months
108
Consent Approach
Informed consent is obtained from participants (age ≥18) via subject information and informed consent forms (Main ICD/ICF Part 1 and Part 2 and numerous country-specific ICF/ICD documents). Multiple country/language ICFs are included in the submission (examples: EN, GR, FR, PL, IT, NL, DE, ES, CZ, FI among others). Prescreening consent forms (prescreen ICDs, PPRIF) and optional-procedure/ICD addenda are provided as separate documents.

Methods

  • Clinic posters (country-specific clinic poster documents listed)
  • Study flyers (country-specific study flyer materials)
  • Program-level brochures and brochure inserts (country-specific)
  • Video postcards / digital video materials (Video Postcard ME / BLT documents)
  • Website/homepage materials (program study page / homepage materials listed)
  • Referral letters and study visit guides (country-specific recruitment docs)
  • Pre-screening and prescreen consent processes (Massive Bio / prescreening ICD and PPRIF documents available)

Geography

Total Number Of Sites
82
Total Number Of Participants
444

Greece

Latest Decision Or Authorization Date
18-10-2024
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
Evaggelismos Hospital
Department Name
Hematology and Lymphoma Clinic - Bone Marrow Transplantation Unit
Principal Investigator Name
Sosana Delimpasi
Principal Investigator Email
sodeli@yahoo.com
Contact Person Name
Sosana Delimpasi
Contact Person Email
sodeli@yahoo.com
Site Name
Alexandra Hospital
Department Name
Oncology
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
University General Hospital Of Ioannina
Department Name
Haematology
Principal Investigator Name
Eleftheria Hatzimichael
Principal Investigator Email
ehatzim@uoi.gr
Contact Person Name
Eleftheria Hatzimichael
Contact Person Email
ehatzim@uoi.gr
Site Name
Theageneio Cancer Hospital
Department Name
Hematlogy/Oncology
Principal Investigator Name
Eirini Katroditou
Principal Investigator Email
eirinikatodritou@gmail.com
Contact Person Name
Eirini Katroditou
Contact Person Email
eirinikatodritou@gmail.com

France

Latest Decision Or Authorization Date
05-08-2024
Number Of Sites
7
Number Of Participants
61

Sites

Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology
Principal Investigator Name
Xavier Leleu
Principal Investigator Email
xavier.leleu@chu-poitiers.fr
Contact Person Name
Xavier Leleu
Contact Person Email
xavier.leleu@chu-poitiers.fr
Site Name
Institut Gustave Roussy
Department Name
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
Centre Hospitalier Universitaire De Nice
Department Name
Hematology
Principal Investigator Name
Valentine RICHEZ-OLIVIER
Principal Investigator Email
richez-olivier.v@chu-nice.fr
Contact Person Name
Valentine RICHEZ-OLIVIER
Contact Person Email
richez-olivier.v@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology
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
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
Hopital Saint Antoine
Department Name
Hematology and Cellular Therapy
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
CHU Bretonneau
Department Name
Hematology
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

Poland

Latest Decision Or Authorization Date
04-08-2024
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
"Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku"
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
tomasz_wrobel@wp.pl
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz_wrobel@wp.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Agata Tyczynska
Principal Investigator Email
atyczynska@uck.gda.pl
Contact Person Name
Agata Tyczynska
Contact Person Email
atyczynska@uck.gda.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

Italy

Latest Decision Or Authorization Date
06-08-2024
Number Of Sites
14
Number Of Participants
110

Sites

Site Name
Casa Sollievo Della Sofferenza
Department Name
U.O.C. di 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
ASL PESCARA-Presidio Ospedaliero Pescara
Department Name
Dipartimento Oncologico Ematologico
Principal Investigator Name
Mauro Di Ianni
Principal Investigator Email
mauro.diianni@asl.pe.it
Contact Person Name
Mauro Di Ianni
Contact Person Email
mauro.diianni@asl.pe.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Ematologia Adulti
Principal Investigator Name
Carlo Gambacorti- Passerini
Principal Investigator Email
carlo.gambacorti@unimib.it
Contact Person Name
Carlo Gambacorti- Passerini
Contact Person Email
carlo.gambacorti@unimib.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Ematologia
Principal Investigator Name
Sara Galimberti
Principal Investigator Email
sara.galimberti@med.unipi.it
Contact Person Name
Sara Galimberti
Contact Person Email
sara.galimberti@med.unipi.it
Site Name
Azienda Ospedaliera Universitaria Senese - (ITT) - Center for Immuno-Oncology (CIO)
Department Name
U.O.C. Ematologia
Principal Investigator Name
Alessandro Gozzetti
Principal Investigator Email
gozzetti@unisi.it
Contact Person Name
Alessandro Gozzetti
Contact Person Email
gozzetti@unisi.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
U.O. Ematologia
Principal Investigator Name
Sergio Siragusa
Principal Investigator Email
sergio.siragusa@unipa.it
Contact Person Name
Sergio Siragusa
Contact Person Email
sergio.siragusa@unipa.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
UOC Ematologia
Principal Investigator Name
Monica Galli
Principal Investigator Email
monicagalli@asst-pg23.it
Contact Person Name
Monica Galli
Contact Person Email
monicagalli@asst-pg23.it
Site Name
Azienda Ospedaliera G. Brotzu
Department Name
S.C. Ematologia e CTMO
Principal Investigator Name
Daniele Derudas
Principal Investigator Email
daniele.derudas@aob.it
Contact Person Name
Daniele Derudas
Contact Person Email
daniele.derudas@aob.it
Site Name
AOU Policlinico Umberto I -Università degli studi di Roma "La Sapienza"
Department Name
Dipartimento di medicina traslazionale e di precisione
Principal Investigator Name
Maurizio Martelli
Contact Person Name
Maurizio Martelli
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
Oncologia ed Ematologia
Principal Investigator Name
Lucia Morello
Principal Investigator Email
l.morello@ausl.pc.it
Contact Person Name
Lucia Morello
Contact Person Email
l.morello@ausl.pc.it
Site Name
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino- Presidio Molinette
Department Name
Hematology U Division / SSD Clinical Trial in Oncohematology and Multiple Myeloma
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
Ospedale Santa Maria delle Croci
Department Name
Dipartimento di Oncologia ed Ematologia
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
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncologia Medica
Principal Investigator Name
Mariagrazia Michieli
Principal Investigator Email
mmichieli@cro.it
Contact Person Name
Mariagrazia Michieli
Contact Person Email
mmichieli@cro.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncoematologia
Principal Investigator Name
Enrico Derenzini
Principal Investigator Email
enrico.derenzini@ieo.it
Contact Person Name
Enrico Derenzini
Contact Person Email
enrico.derenzini@ieo.it

Finland

Latest Decision Or Authorization Date
05-08-2024
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Oulu University Hospital
Department Name
Department of Oncology and Hematology
Principal Investigator Name
Marjaana Säily
Principal Investigator Email
Marjaana.saily@pohde.fi
Contact Person Name
Marjaana Säily
Contact Person Email
Marjaana.saily@pohde.fi
Site Name
Kuopio University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Anu Partanen
Principal Investigator Email
anu.partanen@pshyvinvointialue.fi
Contact Person Name
Anu Partanen
Site Name
HUS-Yhtymae
Department Name
Department of Hematology
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
Kymenlaakson keskussairaala
Principal Investigator Name
Varmavuo Ville
Principal Investigator Email
ville.varmavuo@kymenhva.fi
Contact Person Name
Varmavuo Ville
Contact Person Email
ville.varmavuo@kymenhva.fi
Site Name
Turku University Hospital
Principal Investigator Name
Mervi Putkonen
Principal Investigator Email
mervi.putkonen@tyks.fi
Contact Person Name
Mervi Putkonen
Contact Person Email
mervi.putkonen@tyks.fi

Austria

Latest Decision Or Authorization Date
05-08-2024
Number Of Sites
10
Number Of Participants
24

Sites

Site Name
Universitatsklinikum St. Polten
Department Name
Klinische Abteilung für Innere Medizin 1
Principal Investigator Name
Petra Pichler
Principal Investigator Email
petra.pichler@stpoelten.lknoe.at
Contact Person Name
Petra Pichler
Site Name
Medizinische Universitaet Innsbruck
Department Name
Abteilung für Innere Medizin
Principal Investigator Name
Wolfgang Willenbacher
Principal Investigator Email
wolfgang.willenbacher@tirol-kliniken.at
Contact Person Name
Wolfgang Willenbacher
Site Name
Landeskrankenhaus Feldkirch
Department Name
Abteilung für Interne E
Principal Investigator Name
Bernd Hartmann
Principal Investigator Email
bernd.hartmann@lkhf.at
Contact Person Name
Bernd Hartmann
Contact Person Email
bernd.hartmann@lkhf.at
Site Name
Universitätsklinik für Innere Medizin III Salzburg
Department Name
Hämatologie
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
Medizinische Abteilung Zentrum für Onkologie und Hämatologie
Principal Investigator Name
Martin Schreder
Principal Investigator Email
martin.schreder@gesundheitsverbund.at
Contact Person Name
Martin Schreder
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Abteilung für Innere Medizin IV
Principal Investigator Name
Sonja Heibl
Principal Investigator Email
sonja.heibl@klinikum-wegr.at
Contact Person Name
Sonja Heibl
Contact Person Email
sonja.heibl@klinikum-wegr.at
Site Name
Universitatsklinikum Graz
Department Name
Abteilung für Innere Medizin
Principal Investigator Name
Siegfried Sormann
Principal Investigator Email
s.sormann@medunigraz.at
Contact Person Name
Siegfried Sormann
Contact Person Email
s.sormann@medunigraz.at
Site Name
Krankenhaus Der Barmherzigen Schwestern Wien
Department Name
Klinik für Hämatologie und Onkologie
Principal Investigator Name
Eva-Maria Autzinger
Principal Investigator Email
evamaria.autzinger@bhs.at
Contact Person Name
Eva-Maria Autzinger
Contact Person Email
evamaria.autzinger@bhs.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Abteilung für Medizinische Hämatologie und Onkologie
Principal Investigator Name
Manuel Orlinger
Principal Investigator Email
manuel.orlinger@ordensklinikum.at
Contact Person Name
Manuel Orlinger
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

Germany

Latest Decision Or Authorization Date
02-08-2024
Number Of Sites
9
Number Of Participants
27

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Medizinische Klinik und Poliklinik für Hämatologie und Onkologie
Principal Investigator Name
Christian Sebastian Michel
Principal Investigator Email
christian.michel@unimedizin-mainz.de
Contact Person Name
Christian Sebastian Michel
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Medizinische Klinik, Abteilung III
Principal Investigator Name
Christoph Schünemann
Principal Investigator Email
c.schuenemann@skbs.de
Contact Person Name
Christoph Schünemann
Contact Person Email
c.schuenemann@skbs.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Klninik für Onkologie, Hämatologie, Palliativmedizin
Principal Investigator Name
Hans-Jürgen Salwender
Principal Investigator Email
h.salwender@asklepios.com
Contact Person Name
Hans-Jürgen Salwender
Contact Person Email
h.salwender@asklepios.com
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Zentrum für Innere Medizin III
Principal Investigator Name
Miriam Kull
Principal Investigator Email
miriam.kull@uniklinik-ulm.de
Contact Person Name
Miriam Kull
Contact Person Email
miriam.kull@uniklinik-ulm.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Innere Medizin III
Principal Investigator Name
Mathias Haenel
Principal Investigator Email
m.haenel@skc.de
Contact Person Name
Mathias Haenel
Contact Person Email
m.haenel@skc.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klninik für Onkologie, Hämatologie, Palliativmedizin,
Principal Investigator Name
Sabine Gärditz
Principal Investigator Email
sabine.gaerditz@klinik.uni-regensburg.de
Contact Person Name
Sabine Gärditz
Site Name
Medical Center - University Of Freiburg
Department Name
Kinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzellentransplantation
Principal Investigator Name
Monika Engelhardt
Principal Investigator Email
monika.engelhardt@uniklinik-freiburg.de
Contact Person Name
Monika Engelhardt
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik, Abteilung II
Principal Investigator Name
Britta Besemer
Principal Investigator Email
britta.besemer@med.uni-tuebingen.de
Contact Person Name
Britta Besemer
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Principal Investigator Name
Deniz Gezer
Principal Investigator Email
dgezer@ukaachen.de
Contact Person Name
Deniz Gezer
Contact Person Email
dgezer@ukaachen.de

Spain

Latest Decision Or Authorization Date
01-08-2024
Number Of Sites
14
Number Of Participants
93

Sites

Site Name
Institut Catala D'oncologia (Girona)
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 Universitari Mutua Terrassa
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
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Haematology Department
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
Hospital Germans Trias I Pujol
Department Name
Instituto Catalán de Oncología de Badalona
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 Marques De Valdecilla
Principal Investigator Name
Enrique Ocio San Miguel
Principal Investigator Email
ocioem@unican.es
Contact Person Name
Enrique Ocio San Miguel
Contact Person Email
ocioem@unican.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Principal Investigator Name
Elham Askari
Principal Investigator Email
easkari@quironsalud.es
Contact Person Name
Elham Askari
Contact Person Email
easkari@quironsalud.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
Site Name
Hospital Clinic De Barcelona
Principal Investigator Name
Carlos Jose Fernandez de Larrea Rodriguez
Principal Investigator Email
cfernan1@clinic.cat
Contact Person Name
Carlos Jose Fernandez de Larrea Rodriguez
Contact Person Email
cfernan1@clinic.cat
Site Name
Hospital San Pedro De Alcantara
Department Name
Hematology
Principal Investigator Name
Ignacio Casas
Principal Investigator Email
lgnacio.casas@salud-juntaex.es
Contact Person Name
Ignacio Casas
Contact Person Email
lgnacio.casas@salud-juntaex.es
Site Name
Hospital Universitario Regional De Malaga
Principal Investigator Name
Maria Magdalena Alcalá Peña
Principal Investigator Email
kikistrata@hotmail.com
Contact Person Name
Maria Magdalena Alcalá Peña
Contact Person Email
kikistrata@hotmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
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 Dr Peset Aleixandre
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
Site Name
Clinica Universidad De Navarra
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 Universitario De La Princesa
Principal Investigator Name
Adrian Alegre Amor
Principal Investigator Email
adrian.alegre@salud.madrid.org
Contact Person Name
Adrian Alegre Amor
Contact Person Email
adrian.alegre@salud.madrid.org

Netherlands

Latest Decision Or Authorization Date
31-07-2024
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Albert Schweitzer Ziekenhuis
Department Name
Internal Medicine
Principal Investigator Name
Mark-David Levin
Principal Investigator Email
m-d.levin@asz.nl
Contact Person Name
Mark-David Levin
Contact Person Email
m-d.levin@asz.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Principal Investigator Name
Wouter Plattel
Principal Investigator Email
w.j.plattel@umcg.nl
Contact Person Name
Wouter Plattel
Contact Person Email
w.j.plattel@umcg.nl

Belgium

Latest Decision Or Authorization Date
31-07-2024
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Clinique Saint-Pierre
Principal Investigator Name
Thierry Connerotte
Principal Investigator Email
thierry.connerotte@cspo.be
Contact Person Name
Thierry Connerotte
Contact Person Email
thierry.connerotte@cspo.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
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Principal Investigator Name
Gaspard Jadot
Principal Investigator Email
gaspard.jadot@chuuclnamur.uclouvain.be
Contact Person Name
Gaspard Jadot
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
Algemeen Ziekenhuis Delta
Principal Investigator Name
Lien Deleu
Principal Investigator Email
lien.deleu@azdelta.be
Contact Person Name
Lien Deleu
Contact Person Email
lien.deleu@azdelta.be
Site Name
Universitair Ziekenhuis 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
UZ Brussel
Principal Investigator Name
Sylvia Faict
Principal Investigator Email
sylvia.faict@uzbrussel.be
Contact Person Name
Sylvia Faict
Contact Person Email
sylvia.faict@uzbrussel.be

Denmark

Latest Decision Or Authorization Date
31-07-2024
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Lillebaelt Hospital
Principal Investigator Name
Sarah Farmer
Principal Investigator Email
sarah.farmer1@rsyd.dk
Contact Person Name
Sarah Farmer
Contact Person Email
sarah.farmer1@rsyd.dk
Site Name
Aarhus Universitetshospital
Department Name
Blodsygdomme
Principal Investigator Name
Maja Vase
Principal Investigator Email
majavase@rm.dk
Contact Person Name
Maja Vase
Contact Person Email
majavase@rm.dk
Site Name
Odense University Hospital
Department Name
Dep. of Hematology
Principal Investigator Name
Charlotte Toftmann Hansen
Principal Investigator Email
Charlotte.Toftmann.Hansen2@rsyd.dk
Contact Person Name
Charlotte Toftmann Hansen
Site Name
Rigshospitalet
Principal Investigator Name
Agoston Gyula Szabo
Principal Investigator Email
agoston.gyula.szabo@regionh.dk
Contact Person Name
Agoston Gyula Szabo
Contact Person Email
agoston.gyula.szabo@regionh.dk

Czechia

Latest Decision Or Authorization Date
01-08-2024
Number Of Sites
3
Number Of Participants
49

Sites

Site Name
University Hospital Olomouc
Department Name
Hemato-onkologická klinika
Principal Investigator Name
Jiří Minařík
Principal Investigator Email
abretina@email.cz
Contact Person Name
Jiří Minařík
Contact Person Email
abretina@email.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
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. 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

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Logistics, analysis of the disease assessment labs, cytogenetics & storage
Name
WCG Clinical Inc.
Responsibilities
Patient Recruitment and Retention
Name
Premier Research

Third parties

  • {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"Project Management","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Signant Health","duties_or_roles":"ePRO (electronic Patient Reported Outcome)","organisation_type":"Industry"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Logistics, analysis of the disease assessment labs, cytogenetics & storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive","duties_or_roles":"primary/surrogate endpoint test","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Pre-screening activities","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Patient Recruitment and Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Delve Bio, Inc.","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Premier Research","duties_or_roles":"","organisation_type":"Industry"}

Investigational products

Investigational Product Name
ELRANATAMAB
Active Substance
ELRANATAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
Not authorised
Maximum Dose
76 mg
Combination Treatment
Yes

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