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
- 12-08-2024
- First CTIS Authorization Date
- 05-09-2024
Trial design
Randomised, open-label, elranatamab monotherapy (arm a) and elranatamab + daratumumab (arm b) versus daratumumab + pomalidomide + dexamethasone (comparator arm). comparator products in the study include daratumumab (darzalex 1800 mg sc), pomalidomide (imnovid capsules; product strengths 1 mg, 2 mg, 3 mg, 4 mg; max daily amount listed 4 mg) and dexamethasone (neofordex 40 mg tablets; max daily amount listed 40 mg).-controlled, adaptive Phase III trial across 77 sites in Germany, Greece, Belgium and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Elranatamab monotherapy (Arm A) and Elranatamab + Daratumumab (Arm B) versus Daratumumab + Pomalidomide + Dexamethasone (comparator arm). Comparator products in the study include Daratumumab (Darzalex 1800 mg SC), Pomalidomide (Imnovid capsules; product strengths 1 mg, 2 mg, 3 mg, 4 mg; max daily amount listed 4 mg) and Dexamethasone (Neofordex 40 mg tablets; max daily amount listed 40 mg).
- Adaptive
- True, Part 1 includes dose-escalation elements to assess DLTs and select a recommended phase 3 dose (RP3D) for the elranatamab + daratumumab combination; 2-step priming regimen and DLT observation windows are used.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 500
Eligibility
Recruits 500 adults.
- Pregnancy Exclusion
- 20. For women of childbearing potential: Pregnancy test positive at screening.
Inclusion criteria
- {"criterion_text":"- 1. Participants age ≥18 years (or the minimum country-specific age of consent if >18)."}
- {"criterion_text":"- 2. Prior diagnosis of multiple myeloma (MM) as defined according to IMWG criteria (Rajkumar et al, 2014)."}
- {"criterion_text":"- 3. Measurable disease based on IMWG criteria as defined by at least 1 of the following: Serum M-protein ≥0.5 g/dL; Urinary M-protein excretion ≥200 mg/24 hours; Serum immunoglobulin 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":"- 4. Prior anti-MM therapy: Part 1: At least 3 prior lines of anti-MM therapy including treatment with lenalidomide and a PI. Part 2: At least 1, but not more than 3, prior lines of anti-MM therapy including treatment with lenalidomide and a PI. Part 3 Arm D: At least 1, but not more than 3, prior lines of anti-MM therapy including treatment with lenalidomide and an anti-CD38-directed therapy. Part 3 Arm E: At least 1, but not more than 3, prior lines of anti-MM therapy including treatment with lenalidomide."}
- {"criterion_text":"- 5. Eastern Cooperative Oncology Group (ECOG) performance status <2."}
- {"criterion_text":"- 6. Left ventricular ejection fraction (LVEF) ≥40% as determined by a multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)."}
- {"criterion_text":"- 7. Adequate hepatic, renal and bone marrow (BM) function."}
- {"criterion_text":"- 8. Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)."}
- {"criterion_text":"- 9. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1."}
Exclusion criteria
- {"criterion_text":"- 1. Smoldering MM."}
- {"criterion_text":"- 7. Ongoing Grade 3 or higher peripheral sensory or motor neuropathy."}
- {"criterion_text":"- 10. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 malignancy with minimal risk of recurrence per investigator."}
- {"criterion_text":"- 8. History of Guillain-Barrė syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy."}
- {"criterion_text":"- 9. Active hepatitis B virus (HBV), hepatitis C virus (HCV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), human immunodeficiency virus (HIV), or any active, uncontrolled bacterial, fungal, or viral infection."}
- {"criterion_text":"- 15. Part 3 Arm E: Refractory to prior anti-CD38-directed therapy (disease progression while on or within 60 days of the last dose of any anti-CD38-directed therapy)."}
- {"criterion_text":"- 11. Participants with known or suspected hypersensitivity to the study interventions or any of their excipients."}
- {"criterion_text":"- 12. Previous treatment with a BCMA-directed therapy or a CD3-redirecting therapy."}
- {"criterion_text":"- 13. Parts 1 and 2: Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study."}
- {"criterion_text":"- 14. Part 2: Refractory to prior anti-CD38-directed therapy (disease progression while on or within 60 days of the last dose of any anti-CD38-directed therapy or failure to achieve at least MR)."}
- {"criterion_text":"- 16. Part 2: Previous pomalidomide therapy."}
- {"criterion_text":"- 19. Administration with an investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study. A participant may be eligible if they are in the follow-up phase of an investigational study if they meet the criterion for time elapsed from previous administration of investigational product. Cases must be discussed with sponsor’s medical monitor to judge eligibility."}
- {"criterion_text":"- 17. Part 3: Any anti-myeloma drug therapy within 14 days of the first dose of study intervention (includes dexamethasone)."}
- {"criterion_text":"- 18. Live attenuated vaccine must not be administered within 4 weeks of the first dose of study intervention. Refer to Section 6.8 Concomitant Therapy."}
- {"criterion_text":"- 2. Plasma cell leukemia."}
- {"criterion_text":"- 20. For women of childbearing potential: Pregnancy test positive at screening."}
- {"criterion_text":"- 21. Part 2: Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed (assuming no drug interaction potential)."}
- {"criterion_text":"- 3. Amyloidosis, Waldenström’s macroglobulinemia, or POEMS Syndrome."}
- {"criterion_text":"- 4. Known active CNS involvement or clinical signs of myelomatous meningeal involvement."}
- {"criterion_text":"- 5. Stem cell transplant within 12 weeks prior to enrollment, active GVHD (other than Grade 1 skin involvement), or GVHD requiring treatment."}
- {"criterion_text":"- 6. Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Part 1: DLTs during the DLT observation period (14 days from first elranatamab dose + first 28 days following first dose of elranatamab + daratumumab).","definition_or_measurement_approach":"Dose-limiting toxicities (DLTs) assessed during the specified DLT observation period: 14 days from first elranatamab dose plus the first 28 days following first dose of elranatamab + daratumumab (as stated)."}
- {"endpoint_text":"- Part 2: PFS by blinded independent central review (BICR) per IMWG","definition_or_measurement_approach":"Progression-free survival (PFS) assessed by blinded independent central review (BICR) according to IMWG criteria."}
- {"endpoint_text":"- Part 3: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, and seriousness, and relationship to study treatment during the first 84 days following first elranatamab dose. Severity of CRS and ICANS will be assessed according to ASTCT criteria","definition_or_measurement_approach":"Adverse events characterized by type, frequency, severity (NCI CTCAE v5.0), timing, seriousness and relationship to treatment during first 84 days after first elranatamab dose. Cytokine release syndrome (CRS) and ICANS severity assessed per ASTCT criteria."}
Secondary endpoints
- {"endpoint_text":"- Part 1: Grade ≥2 CRS rate during the 28 days following the first dose of elranatamab.","definition_or_measurement_approach":"Rate of cytokine release syndrome (CRS) of Grade ≥2 within 28 days after first elranatamab dose (graded per CTCAE/Astct definitions as specified)."}
- {"endpoint_text":"- Part 1: Adverse events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to elranatamab in combination with daratumumab. Severity of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) will be assessed according to ASTCT criteria; •Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing.","definition_or_measurement_approach":"AEs and laboratory abnormalities characterized as per NCI CTCAE v5.0; CRS and ICANS severity per ASTCT criteria."}
- {"endpoint_text":"- Part1: ORR and CRR, per IMWG (International Myeloma Working Group) response criteria as determined by investigator; • Time to event endpoints: TTR, DOR, DOCR and PFS per IMWG response criteria as determined by investigator, and OS; • MRD negativity rate (central lab) per IMWG sequencing criteria.","definition_or_measurement_approach":"Objective response rate (ORR), complete response rate (CRR) per IMWG by investigator; time-to-event endpoints (TTR, DOR, DOCR, PFS) per IMWG; overall survival (OS); MRD negativity assessed centrally per IMWG sequencing criteria."}
- {"endpoint_text":"- Part 1: Predose and postdose concentrations of elranatamab","definition_or_measurement_approach":"Pharmacokinetic measurement of elranatamab concentrations pre-dose and post-dose."}
- {"endpoint_text":"- Part 1: Anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against elranatamab.","definition_or_measurement_approach":"Assessment of immunogenicity by measuring ADAs and NAbs to elranatamab."}
- {"endpoint_text":"- Part 1: Predose concentrations of daratumumab.","definition_or_measurement_approach":"Measurement of daratumumab trough (predose) concentrations."}
- {"endpoint_text":"- Part 2 Key secondary: OS.","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomization to death from any cause."}
- {"endpoint_text":"- Part 2: •PFS and PFS2 by Investigator per IMWG •ORR by BICR per IMWG •DOR by BICR per IMWG •CRR by BICR per IMWG •DOCR by BICR per IMWG •TTR by BICR per IMWG •MRD negativity rate (central lab) per IMWG •Sustained MRD negativity rate (central lab) per IMWG","definition_or_measurement_approach":"Multiple efficacy endpoints for Part 2 measured per IMWG: investigator-assessed PFS/PFS2; ORR, DOR, CRR, DOCR, TTR by BICR; MRD and sustained MRD by central laboratory per IMWG."}
- {"endpoint_text":"- Part 2: • 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 assessed according to ASTCT criteria. • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing.","definition_or_measurement_approach":"Safety endpoints characterized per NCI CTCAE v5.0; CRS/ICANS severity per ASTCT; laboratory abnormalities described by type/frequency/severity/timing."}
- {"endpoint_text":"- Part 2: Predose and postdose concentrations of elranatamab.","definition_or_measurement_approach":"Pharmacokinetic assessment of elranatamab pre- and post-dose in Part 2."}
- {"endpoint_text":"- Part 2: ADAs and NAbs against elranatamab.","definition_or_measurement_approach":"Assessment of anti-drug antibodies and neutralizing antibodies against elranatamab."}
- {"endpoint_text":"- Part 2: of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ-C30) and myeloma quality of life questionnaire (MY20).","definition_or_measurement_approach":"Health-related quality of life measured using EORTC QLQ-C30 and myeloma-specific MY20 questionnaires."}
- {"endpoint_text":"- Part 3: • AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study treatment. Severity of CRS and ICANS will be assessed according to ASTCT criteria • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing","definition_or_measurement_approach":"Safety endpoints in Part 3 characterized per NCI CTCAE v5.0; CRS/ICANS per ASTCT; laboratory abnormalities recorded and graded per CTCAE v5.0."}
- {"endpoint_text":"- Part 3: • ORR and CRR per IMWG • Time to event endpoints: TTR, DOR, DOCR and PFS per IMWG response criteria, and OS • MRD negativity rate (central lab) per IMWG • Sustained MRD negativity rate (central lab) per IMWG","definition_or_measurement_approach":"Efficacy endpoints in Part 3 measured per IMWG: ORR/CRR, TTR, DOR, DOCR, PFS, OS; MRD and sustained MRD by central lab per IMWG."}
- {"endpoint_text":"- Part 3: Predose and postdose concentrations of elranatamab","definition_or_measurement_approach":"PK assessments of elranatamab pre- and post-dose in Part 3."}
- {"endpoint_text":"- Part 3: ADAs and NAbs against elranatamab","definition_or_measurement_approach":"Assessment of immunogenicity (ADAs and NAbs) against elranatamab in Part 3."}
- {"endpoint_text":"- Part 3: Predose concentrations of daratumumab","definition_or_measurement_approach":"Measurement of daratumumab predose concentrations in Part 3."}
Recruitment
- Planned Sample Size
- 500
- Recruitment Window Months
- 82
- Consent Approach
- Informed consent is obtained from the participant (participants must be ≥18 years old, or meet the minimum country-specific age of consent where >18). Subject information and informed consent forms are provided per country; multiple country-specific informed consent documents are available in local languages (document list includes country-specific ICDs and recruitment/informed consent procedure files in languages such as DE, EN, EL, FR, NL, PL, IT, ES, SE, NO, FI).
Geography
- Total Number Of Sites
- 77
- Total Number Of Participants
- 361
Germany
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 596
- Number Of Sites
- 6
- Number Of Participants
- 19
Sites
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Klinik für Innere Medizin III
- Principal Investigator Name
- Mathias Haenel
- Contact Person Name
- Mathias Haenel
- Contact Person Email
- m.haenel@skc.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Hämatologie-Onkologie-Tumorimmunologie CC14 - Campus Benjamin Franklin
- Principal Investigator Name
- Stephan Rainer Maximilian Bohl
- Contact Person Name
- Stephan Rainer Maximilian Bohl
- Contact Person Email
- Stephan.bohl@charite.de
- Site Name
- Staedtisches Klinikum Braunschweig gGmbH
- Department Name
- Medizinische Klinik III
- Principal Investigator Name
- Miriam Ahlborn
- Contact Person Name
- Miriam Ahlborn
- Contact Person Email
- m.ahlborn@klinikum-braunschweig.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Department of Internal Medicine III
- Principal Investigator Name
- Miriam Kull
- Contact Person Name
- Miriam Kull
- Contact Person Email
- miriam.kull@uniklinik-ulm.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
- Contact Person Name
- Florian Bassermann
- Contact Person Email
- florian.bassermann@mri.tum.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II Zentrum Innere Medizin (ZIM)
- Principal Investigator Name
- Klaus Martin Kortuem
- Contact Person Name
- Klaus Martin Kortuem
- Contact Person Email
- kortuem_m@ukw.de
Greece
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 541
- Number Of Sites
- 4
- Number Of Participants
- 14
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Clinical Therapeutics Department
- Principal Investigator Name
- Meletios Athanasios Dimopoulos
- Contact Person Name
- Meletios Athanasios Dimopoulos
- Contact Person Email
- mdimop@med.uoa.gr
- Site Name
- Theageneio Cancer Hospital
- Department Name
- Hematology Department
- Principal Investigator Name
- Eirini Katodritou
- Contact Person Name
- Eirini Katodritou
- Contact Person Email
- eirinikatodritou@gmail.com
- Site Name
- Evaggelismos Hospital
- Department Name
- Hematology Department
- Principal Investigator Name
- Sosanna Delimpasi
- Contact Person Name
- Sosanna Delimpasi
- Contact Person Email
- sodeli@yahoo.com
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Hematology Department
- Principal Investigator Name
- Eleftheria Hatzimichael
- Contact Person Name
- Eleftheria Hatzimichael
- Contact Person Email
- ehatzim@uoi.gr
Belgium
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 594
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Oncology & Hematology
- Principal Investigator Name
- Geraldine Verstraete
- Contact Person Name
- Geraldine Verstraete
- Contact Person Email
- Geraldine.verstraete@ghdc.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Service d'Hématologie
- Principal Investigator Name
- Julien Depaus
- Contact Person Name
- Julien Depaus
- Contact Person Email
- julien.depaus@chuuclnamur.uclouvain.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 593
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Internal Medicine
- Principal Investigator Name
- Catharina Hubertina Maria Johanna Van Elssen
- Contact Person Name
- Catharina Hubertina Maria Johanna Van Elssen
- Contact Person Email
- janine.van.elssen@mumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematology
- Principal Investigator Name
- Annemiek Broijl
- Contact Person Name
- Annemiek Broijl
- Contact Person Email
- a.broyl@erasmusmc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 599
- Number Of Sites
- 7
- Number Of Participants
- 32
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Dominik Dytfeld
- Contact Person Name
- Dominik Dytfeld
- Contact Person Email
- dytfeld@me.com
- Site Name
- Pratia Onkologia Katowice
- Principal Investigator Name
- Sebastian Grosicki
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- agata.kachel-flis@pratia.com
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Centralny Szpital Kliniczny Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
- Principal Investigator Name
- Krzysztof Jamroziak
- Contact Person Name
- Krzysztof Jamroziak
- Contact Person Email
- kjamroziak@wum.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
- Principal Investigator Name
- Tomasz Wrobel
- Contact Person Name
- Tomasz Wrobel
- Contact Person Email
- tomasz_wrobel@wp.pl
- Site Name
- Aidport Sp. z o.o.
- Principal Investigator Name
- Łukasz Pruchniewski
- Contact Person Name
- Łukasz Pruchniewski
- Contact Person Email
- Lukasz.pruchniewski@aidport.pl
- Site Name
- In Vivo Sp. z o.o.
- Principal Investigator Name
- Jarosław Czyż
- Contact Person Name
- Jarosław Czyż
- Contact Person Email
- jczyz@onet.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii Centrum Medycyny Nieinwazyjnej
- Principal Investigator Name
- Magdalena Dutka
- Contact Person Name
- Magdalena Dutka
- Contact Person Email
- dmag77@gumed.edu.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 594
- Number Of Sites
- 6
- Number Of Participants
- 40
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. Interni klinika, klinika hematologie
- Principal Investigator Name
- Ivan Spicka
- Contact Person Name
- Ivan Spicka
- Contact Person Email
- spicka@cesnet.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Hemato-onkologická klinika
- Principal Investigator Name
- Jiri Minarik
- Contact Person Name
- Jiri Minarik
- Contact Person Email
- abretina@email.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní hematologická a onkologická klinika
- Principal Investigator Name
- Ludek Pour
- Contact Person Name
- Ludek Pour
- Contact Person Email
- pour.ludek@fnbrno.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Department of haematooncology, University hospital Ostrava
- Principal Investigator Name
- Tereza Popkova
- Contact Person Name
- Tereza Popkova
- Contact Person Email
- tereza.popkova@fno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- 4th Department of Internal Medicie - Hematology
- Principal Investigator Name
- Jakub Radocha
- Contact Person Name
- Jakub Radocha
- Contact Person Email
- jakub.radocha@fnhk.cz
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- Hemato-Onkologicke oddeleni
- Principal Investigator Name
- Alexandra Jungova
- Contact Person Name
- Alexandra Jungova
- Contact Person Email
- jungovaa@fnplzen.cz
Finland
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 594
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Turku University Hospital
- Principal Investigator Name
- Mervi Putkonen
- Contact Person Name
- Mervi Putkonen
- Contact Person Email
- mervi.putkonen@varha.fi
- Site Name
- Tampere University Hospital
- Principal Investigator Name
- Marja Sankelo
- Contact Person Name
- Marja Sankelo
- Contact Person Email
- marja.sankelo@pirha.fi
- Site Name
- Helsinki University Central Hospital Meilahden Kolmiosairaala
- Department Name
- HUCH Department of Medicine, Division of Hematology
- Principal Investigator Name
- Juha Lievonen
- Contact Person Name
- Juha Lievonen
- Contact Person Email
- juha.lievonen@hus.fi
- Site Name
- Kuopio University Hospital
- Department Name
- Hematologian yksikkö
- Principal Investigator Name
- Anu Partanen
- Contact Person Name
- Anu Partanen
- Contact Person Email
- anu.partanen@kuh.fi
- Site Name
- Oulu University Hospital
- Department Name
- Department of Hematology and Oncology (address: Kiviharjuntie 7, F-building)
- Principal Investigator Name
- Marjaana Säily
- Contact Person Name
- Marjaana Säily
- Contact Person Email
- marjaana.saily@pohde.fi
Sweden
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 593
- Number Of Sites
- 7
- Number Of Participants
- 19
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Department of Hematology
- Principal Investigator Name
- Markus Hansson
- Contact Person Name
- Markus Hansson
- Contact Person Email
- markus.hansson.2@gu.se
- Site Name
- Region Oerebro Laen
- Department Name
- Medicinska kliniken
- Principal Investigator Name
- Jacob Crafoord
- Contact Person Name
- Jacob Crafoord
- Contact Person Email
- jacob.crafoord@regionorebrolan.se
- Site Name
- Falu Lasarett
- Department Name
- Hematology Medical Department
- Principal Investigator Name
- Max Flogegard
- Contact Person Name
- Max Flogegard
- Contact Person Email
- max.Flogegard@regiondalarna.se
- Site Name
- Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
- Department Name
- Dep of Internal Medicine
- Principal Investigator Name
- Ulf-Henrik Mellqvist
- Contact Person Name
- Ulf-Henrik Mellqvist
- Contact Person Email
- ulf-henrik.mellqvist@vgregion.se
- Site Name
- Region Oestergoetland
- Department Name
- Hematologi
- Principal Investigator Name
- Love Tätting
- Contact Person Name
- Love Tätting
- Contact Person Email
- love.tatting@regionostergotland.se
- Site Name
- Sunderby sjukhus
- Principal Investigator Name
- Magnus Johansson
- Contact Person Name
- Magnus Johansson
- Contact Person Email
- magnus.j.johansson@norrbotten.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Department of Hematology
- Principal Investigator Name
- Konstantinos Lemonakis
- Contact Person Name
- Konstantinos Lemonakis
- Contact Person Email
- konstantinos.lemonakis@skane.se
France
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 593
- Number Of Sites
- 8
- Number Of Participants
- 68
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Département d'hématologie
- Principal Investigator Name
- Aurore Perrot
- Contact Person Name
- Aurore Perrot
- Contact Person Email
- Perrot.Aurore@iuct-oncopole.fr
- Site Name
- Hospital Hotel Dieu
- Department Name
- Service Hématologie Clinique
- Principal Investigator Name
- Cyrille Touzeau
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- cyrille.touzeau@chu-nantes.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Service d'Hématologie Clinique
- Principal Investigator Name
- Lionel Karlin
- Contact Person Name
- Lionel Karlin
- Contact Person Email
- lionel.karlin@chu-yon.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Service d'hématologie clinique et thérapie cellulaire
- Principal Investigator Name
- Murielle Roussel
- Contact Person Name
- Murielle Roussel
- Contact Person Email
- murielle.roussel@chu-limoges.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Service d'hématologie et de thérapie cellulaire, Bâtiment Robert André, 2ème étage
- Principal Investigator Name
- Mohamad Mohty
- Contact Person Name
- Mohamad Mohty
- Contact Person Email
- mohamad.mohty@inserm.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
- Contact Person Name
- Xavier Leleu
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service Maladies du sang
- Principal Investigator Name
- Salomon Manier
- Contact Person Name
- Salomon Manier
- Contact Person Email
- Salomon.MANIER@CHRU-LILLE.FR
- Site Name
- Hopital Necker Enfants Malades
- Department Name
- Service Hématologie Adulte
- Principal Investigator Name
- Laurent Frenzel
- Contact Person Name
- Laurent Frenzel
- Contact Person Email
- laurent.frenzel@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 599
- Number Of Sites
- 9
- Number Of Participants
- 35
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Dipartimento di Medicina Traslazionale e di Precisione - Sezione di Ematologia
- Principal Investigator Name
- Maurizio Martelli
- Contact Person Name
- Maurizio Martelli
- Contact Person Email
- principalinvestigatormartelli.dmtp@uniroma1.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- UOC di Ematologia
- Principal Investigator Name
- Francesco Di Raimondo
- Contact Person Name
- Francesco Di Raimondo
- Contact Person Email
- diraimon@unict.it
- Site Name
- Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
- Department Name
- Ematologia
- Principal Investigator Name
- Vittorio Montefusco
- Contact Person Name
- Vittorio Montefusco
- Contact Person Email
- vittorio.montefusco@asst-santipaolocarlo.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Principal Investigator Name
- Matteo Claudio Da Via'
- Contact Person Name
- Matteo Claudio Da Via'
- Contact Person Email
- matteo.davia@policlinico.mi.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Ematologia Adulti
- Principal Investigator Name
- Carlo Gambacorti-Passerini
- Contact Person Name
- Carlo Gambacorti-Passerini
- Contact Person Email
- carlo.gambacorti@unimib.it
- Site Name
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
- Department Name
- Istituto di Ematologia "L.Seragnoli"
- Principal Investigator Name
- Elena Zamagni
- Contact Person Name
- Elena Zamagni
- Contact Person Email
- e.zamagni@unibo.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- servizio di emetologia
- Principal Investigator Name
- Valerio De Stefano
- Contact Person Name
- Valerio De Stefano
- Contact Person Email
- valerio.destefano@unicatt.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
- Contact Person Name
- Claudio Cerchione
- Contact Person Email
- claudio.cerchione@irst.emr.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- U.O.Clinica Ematologica
- Principal Investigator Name
- Roberto Massimo Lemoli
- Contact Person Name
- Roberto Massimo Lemoli
- Contact Person Email
- roberto.lemoli@unige.it
Austria
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 596
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Universitaetsklinikum Krems
- Department Name
- Privatuniversität für Gesundheitswissenschaften Abteilung für Innere Medizin II
- Principal Investigator Name
- Klaus Podar
- Contact Person Name
- Klaus Podar
- Contact Person Email
- klaus.podar@krems.lknoe.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Hämatologie & Medizinische Onkologie
- Principal Investigator Name
- Eberhard Gunsilius
- Contact Person Name
- Eberhard Gunsilius
- Contact Person Email
- eberhard.gunsilius@i-med.ac.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Klinik Ottakring - Medizinische Abteilung, Zentrum für Onkologie und Hämatologie
- Principal Investigator Name
- Martin Schreder
- Contact Person Name
- Martin Schreder
- Contact Person Email
- martin.schreder@gesundheitsverbund.at
- Site Name
- University Hospital Salzburg
- Department Name
- Universitäts-klinik für Innere Medizin III der PMU
- Principal Investigator Name
- Alexander Egle
- Contact Person Name
- Alexander Egle
- Contact Person Email
- a.egle@salk.at
- Site Name
- Medical University Of Vienna
- Department Name
- Univ. Klinik für Innere Medizin I Abteilung für Hämatologie und Hämostaseologie
- Principal Investigator Name
- Maria-Theresa Krauth
- Contact Person Name
- Maria-Theresa Krauth
- Contact Person Email
- maria.krauth@meduniwien.ac.at
Spain
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 596
- Number Of Sites
- 12
- Number Of Participants
- 55
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Principal Investigator Name
- Estrella Carrillo Cruz
- Contact Person Name
- Estrella Carrillo Cruz
- Contact Person Email
- estrellacarrillocruz@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Principal Investigator Name
- Javier de la Rubia Comos
- Contact Person Name
- Javier de la Rubia Comos
- Contact Person Email
- delarubia_jav@gva.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Principal Investigator Name
- Enrique Maria Ocio San Miguel
- Contact Person Name
- Enrique Maria Ocio San Miguel
- Contact Person Email
- ocioem@unican.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Servicio Hematología y Hemoterapia / Oncología, Ensayos Clínicos Fases I START-Madrid-CIOCC
- Principal Investigator Name
- Luis Felipe Casado Montero
- Contact Person Name
- Luis Felipe Casado Montero
- Contact Person Email
- fcasadom@sescam.jccm.es
- Site Name
- Hospital Universitari Mutua Terrassa
- Principal Investigator Name
- Josep Marìa Martí Tutusaus
- Contact Person Name
- Josep Marìa Martí Tutusaus
- Contact Person Email
- ajorba@mutuaterrassa.cat
- Site Name
- Institut Catala D'oncologia (Barcelona site)
- Department Name
- Haematology Department
- Principal Investigator Name
- Ana Maria Sureda Balari
- Contact Person Name
- Ana Maria Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Servicio de Hematologia
- Principal Investigator Name
- Maria Victoria Mateos Manteca
- Contact Person Name
- Maria Victoria Mateos Manteca
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Universitario De Toledo
- Principal Investigator Name
- Jorge Cuesta Tovar
- Contact Person Name
- Jorge Cuesta Tovar
- Contact Person Email
- jorgecuestatovar@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Principal Investigator Name
- Adrian Alegre Amor
- Contact Person Name
- Adrian Alegre Amor
- Contact Person Email
- adrian.alegre@telefonica.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Serv Hematologia
- Principal Investigator Name
- Paula Rodríguez Otero
- Contact Person Name
- Paula Rodríguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Institut Catala D'oncologia (Girona site)
- Principal Investigator Name
- Yolanda González Montes
- Contact Person Name
- Yolanda González Montes
- Contact Person Email
- ygonzalez@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Principal Investigator Name
- Carlos Fernández de Larrea Rodríguez
- Contact Person Name
- Carlos Fernández de Larrea Rodríguez
- Contact Person Email
- cfernan1@clinic.cat
Norway
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 594
- Number Of Sites
- 4
- Number Of Participants
- 27
Sites
- Site Name
- Oslo University Hospital HF Ullevaal
- Department Name
- Oslo myelomatosesenter
- Principal Investigator Name
- Fredrik Schjesvold
- Contact Person Name
- Fredrik Schjesvold
- Contact Person Email
- fredrikschjesvold@gmail.com
- Site Name
- Haukeland Universitetssjukehus
- Department Name
- Medisinsk avdelning
- Principal Investigator Name
- Galina Tsykunova
- Contact Person Name
- Galina Tsykunova
- Contact Person Email
- Galina.tsykunova@helse-bergen.no
- Site Name
- Helse Stavanger HF
- Department Name
- Leif Larsens gate 8 4021 Stavanger, Norway
- Principal Investigator Name
- Kari Lenita Falck Moore
- Contact Person Name
- Kari Lenita Falck Moore
- Contact Person Email
- kari.lenita.falck.moore@sus.no
- Site Name
- St. Olavs Hospital HF
- Principal Investigator Name
- Tobias S. Slordahl
- Contact Person Name
- Tobias S. Slordahl
- Contact Person Email
- tobias.s.slordahl@ntnu.no
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Ltd
- Responsibilities
- subcontracted & logistics, analysis of the disease assessment labs, imaging vendor, BICR vendor, study training LMS
- Name
- PPD Development LP
- Responsibilities
- code 4
- Name
- Icon Development Solutions LLC
- Responsibilities
- code 4
- Name
- Syneos Health Inc.
- Responsibilities
- code 4
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Ltd","duties_or_roles":"subcontracted & logistics, analysis of the disease assessment labs, imaging vendor, BICR vendor, study training LMS","organisation_type":"Industry"}
- {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fulgent Genetics Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"long term storage","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta Biosciences S.A.","duties_or_roles":"analysis of biomarker","organisation_type":"Industry"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Drug Destruction","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Electronic Patient Reported Outcomes (ePRO)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ELRANATAMAB
- Active Substance
- ELRANATAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Investigational (prodAuthStatus 1)
- Orphan Designation
- Yes
- Maximum Dose
- 76 mg
- Investigational Product Name
- DARZALEX 1800 mg solution for injection
- Active Substance
- DARATUMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorized (prodAuthStatus 2)
- Orphan Designation
- Yes
- Maximum Dose
- 1800 mg
- Investigational Product Name
- Imnovid (pomalidomide) hard capsules
- Active Substance
- POMALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorized (prodAuthStatus 2)
- Orphan Designation
- Yes
- Dose Levels
- 1 mg | 2 mg | 3 mg | 4 mg (product strengths listed)
- Maximum Dose
- 4 mg
- Investigational Product Name
- Neofordex 40 mg tablets
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorized (prodAuthStatus 2)
- Maximum Dose
- 40 mg
- Investigational Product Name
- Privigen 100 mg/ml solution for infusion
- Active Substance
- HUMAN NORMAL IMMUNOGLOBULIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Authorized (prodAuthStatus 2)
- Maximum Dose
- 4.8 ml
- Combination Treatment
- Yes
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