Clinical trial • Phase III • Oncology
ETENTAMIG for Relapsed or refractory multiple myeloma
Phase III trial of ETENTAMIG for Relapsed or refractory multiple myeloma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 02-02-2024
- First CTIS Authorization Date
- 24-05-2024
Trial design
Randomised, open-label, investigator's choice standard available therapies (sat) as local standard of care. comparator regimens include therapies containing elotuzumab, bortezomib, pomalidomide, carfilzomib, selinexor, dexamethasone and combinations referenced in protocol (examples referenced in documents and criteria: elopd, kd, svd). dose and schedule not specified in the ctis part i data provided.-controlled Phase III trial in Czechia, Greece, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Investigator's choice Standard Available Therapies (SAT) as local standard of care. Comparator regimens include therapies containing ELOTUZUMAB, BORTEZOMIB, POMALIDOMIDE, CARFILZOMIB, SELINEXOR, DEXAMETHASONE and combinations referenced in protocol (examples referenced in documents and criteria: EloPd, Kd, SVd). Dose and schedule not specified in the CTIS Part I data provided.
- Target Sample Size
- 251
Eligibility
Recruits 251 The dataset flags that a vulnerable population is selected (isVulnerablePopulationSelected = true). Consent is obtained via subject information and informed consent forms (country-specific ICFs are provided). There are specific ICF materials for pregnancy (pregnant-subject data release / pregnant partner forms) and optional ICF modules; participants are adults (≥18) so consent is provided by the participant (no assent/children procedures described)..
- Vulnerable Population
- The dataset flags that a vulnerable population is selected (isVulnerablePopulationSelected = true). Consent is obtained via subject information and informed consent forms (country-specific ICFs are provided). There are specific ICF materials for pregnancy (pregnant-subject data release / pregnant partner forms) and optional ICF modules; participants are adults (≥18) so consent is provided by the participant (no assent/children procedures described).
Inclusion criteria
- {"criterion_text":"- Adult individuals, male or female, ≥18 years old.\n- Unresolved adverse reactions or toxicities from prior anticancer therapies must have resolved to Grade 1 or baseline (NCI CTCAE Version 5.0), except for alopecia or fatigue. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss) at the discretion of the investigator.\n- Subject must be eligible to receive the Investigator's choice SAT based on approved prescribing information, previous MM treatment history, and institutional guidelines.\n- Subjects must accept to be treated with one of the pre-specified Standard Available Therapies (SAT), based on Investigator's choice of local standard of care.\n- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.\n- Subjects must meet the laboratory parameters, as specified in the study protocol, within 2 weeks prior of the first dose of study treatment.\n- Subjects must has a diagnosis of relapsed and/or refractory MM during or after the subject's last treatment\n- Subjects must have measurable disease within 28 days prior to randomization, defined as at lease 1 of the following: Serum monoclonal paraprotein (M-protein) ≥0.5 g/dL (≥5 g/L); Urine M-protein ≥200 mg/24 hours; In subjects without measurable serum or urine M-protein, serum FLC ≥100 mg/L (10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio.\n- Subject must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.\n- Subject with known HIV will be permitted provided that the subject has an undetectable HIV viral load by standard clinical assays on antiretroviral medication (HAART) and is able to tolerate study treatment per Investigator's judgement."}
Exclusion criteria
- {"criterion_text":"- History of significant cardiovascular or pericardial disease, including uncontrolled angina, arrhythmia, recent myocardial infarction within 6 months of first dose, Class ≥3 New York Heart Association congestive heart failure.\n- SAT-Specific Exclusion Criteria: Subject is not eligible to receive SAT if subject has received prior carfilzomib therapy.\n- Subjects have known central nervous system involvement of MM.\n- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.\n- Known allergies, hypersensitivities, or intolerance to constituents of the study treatment (and its excipients) or derivatives.\n- Subjects have evidence of active hepatitis B (HbsAg positive) infection based on screening blood testing (HBsAg, antiHBc, antiHBs).\n- SAT-Specific Exclusion Criteria: Subject is not eligible to receive SAT if subject has an ongoing condition or history of a condition which is an exclusion per local (or applicable) approved label, package insert, and/or institutional guidelines for any single agent from SAT regimen.\n- Subjects have evidence of active hepatitis C infection based on screening blood testing.\n- Subject has any of the following conditions: - Non-secretory MM; - Active plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 109 /L circulating plasma cells by standard differential; - Waldenstrom's macroglobulinemia; - Light chain amyloidosis; - POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes); - Major surgery within 21 days prior to first dose or during planned study participation; or Acute infections within 14 days prior to first dose of study treatment requiring therapy (antibiotic, antifungal, or antiviral).\n- SAT-Specific Exclusion Criteria: Subject is not eligible to receive Kd if subject has received prior carfilzomib therapy.\n- SAT-Specific Exclusion Criteria: Subject is not eligible to receive SVd if: - Subject has received prior selinexor therapy; - Prior PI treatment is allowed provided that subject achieved ≥PR with no history of discontinuation due to ≥Grade 3 toxicity.\n- SAT-Specific Exclusion Criteria: Subject is not eligible to receive EloPd if subject has received prior elotuzumab or pomalidomide therapy.\n- Subject have a known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV- 2 infection, the subject must have a negative molecular (e.g., PCR) test or 2 negative antigen test results at least 24 hours apart.\n- History of clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the subject's participation in the study.\n- History of any malignancy within the past 3 years with the following exceptions: - Adequately treated in situ carcinoma of the cervix uteri or the breast; - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; - Prostate cancer Gleason Grade 6 or lower AND with stable PSA levels on or off treatment; - Previous malignancy with no evidence of disease confirmed and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression Free Survival (PFS) with Progressive Disease (PD) assessed according to the IMWG (2016) response criteria, per IRC assessment","definition_or_measurement_approach":"Assessed according to the IMWG (2016) response criteria, based on Independent Review Committee (IRC) assessment."}
- {"endpoint_text":"- Overall Response Rate (ORR) per IMWG (2016) response criteria (defined as PR + VGPR + CR + sCR) per IRC assessment","definition_or_measurement_approach":"Defined as PR + VGPR + CR + sCR according to IMWG (2016) response criteria; assessed by IRC."}
Secondary endpoints
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Rate of ≥VGPR per IRC assessment","definition_or_measurement_approach":"Assessment by Independent Review Committee (IRC)."}
- {"endpoint_text":"- Rate of ≥CR per IRC assessment","definition_or_measurement_approach":"Assessment by Independent Review Committee (IRC)."}
- {"endpoint_text":"- Rate of MRD negativity with ≥CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by NGS Adaptive Clonoseq at 10- 5 threshold","definition_or_measurement_approach":"MRD assessed by NGS Adaptive ClonoSEQ at 10^-5 threshold; CR per IMWG (2016) and IRC assessment."}
- {"endpoint_text":"- Change from baseline at 6 months in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20","definition_or_measurement_approach":"Patient-reported disease symptoms domain of EORTC QLQ-MY20 at 6 months vs baseline."}
- {"endpoint_text":"- Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30","definition_or_measurement_approach":"Patient-reported physical functioning domain of EORTC QLQ-C30 at 6 months vs baseline."}
- {"endpoint_text":"- Time to response (TTR) per IRC assessment","definition_or_measurement_approach":"Time from randomization to first documented response per IRC."}
- {"endpoint_text":"- Duration of response (DoR) per IRC assessment","definition_or_measurement_approach":"Time from first documented response to disease progression or death per IRC."}
- {"endpoint_text":"- Time to Disease Progression (TTP) per IRC assessment","definition_or_measurement_approach":"Time from randomization to disease progression per IRC."}
- {"endpoint_text":"- Time to Next Therapy (TTNT)","definition_or_measurement_approach":"Time from randomization to initiation of next anti-myeloma therapy."}
- {"endpoint_text":"- Event free survival (EFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Patient Reported Outcomes (PROs): Change from baseline in the score of remaining scales and items of the EORTC QLQ-C30 and EORTC QLQ-MY20, PROMIS Fatigue SF 7a, EQ-5D-5L, PGIS; scores/frequencies of PGIS, PGIC and select items of the PRO-CTCAE","definition_or_measurement_approach":"Multiple PRO instruments (EORTC QLQ-C30, QLQ-MY20, PROMIS Fatigue SF 7a, EQ-5D-5L, PGIS, PGIC, PRO-CTCAE) comparing change from baseline."}
- {"endpoint_text":"- Skeletal-related event (SREs), defined as presence of any of the following events: - spinal cord compression; - pathologic fracture; - surgery to bone; - radiation to bone","definition_or_measurement_approach":"Occurrence of any listed skeletal-related events (spinal cord compression, pathologic fracture, surgery to bone, radiation to bone)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 251
- Recruitment Window Months
- 40
- Consent Approach
- Informed consent obtained from adult participants (participants are ≥18 years). Country-specific subject information and informed consent forms (ICFs) are provided; multiple language versions and country-specific main/optional/pregnancy ICFs are included (examples: German, English, French, Spanish, Italian, Portuguese, Czech, Greek, Polish, Hungarian, Swedish, Danish, Dutch). There are optional ICF modules and pregnancy/pregnant-partner data release forms where applicable. No assent/children procedures are provided (trial enrols adults).
Methods
- Digital advertising: country-specific digital ads and online materials (e.g., Italy digital ads documents).
- Trial website pages and online recruitment materials (country-specific website PDFs present).
- Physician-to-patient letters to inform local patients (country-specific physician-to-patient letters present).
- Printed materials: recruitment brochures and recruitment posters for clinical sites (country-specific brochures/posters present).
- Site-based materials and flipcharts (ICF flipchart documents for multiple countries).
- Recruitment procedures documents (K1 recruitment and ICF procedures) provided per country.
- Third-party patient recruitment services engaged (Patient Advertising Guru Inc. listed as providing Patient Recruitment Services).
- Patient travel reimbursement support (Greenphire LLC listed for Patient Travel Reimbursement).
Geography
- Total Number Of Sites
- 49
- Total Number Of Participants
- 147
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-04-2024
- Latest Decision Or Authorization Date
- 29-01-2026
- Processing Time Days
- 640
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interni hematologicka a onkologicka klinika
- Principal Investigator Name
- Ludek Pour
- Principal Investigator Email
- pour.ludek@fnbrno.cz
- Contact Person Name
- Ludek Pour
- Contact Person Email
- pour.ludek@fnbrno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV. interni hematologicka klinika
- Principal Investigator Name
- Jakub Radocha
- Principal Investigator Email
- jakub.radocha@fnhk.cz
- Contact Person Name
- Jakub Radocha
- Contact Person Email
- jakub.radocha@fnhk.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Principal Investigator Name
- Jana Mihalyova
- Principal Investigator Email
- jana.mihalyova@fno.cz
- Contact Person Name
- Jana Mihalyova
- Contact Person Email
- jana.mihalyova@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. Interni Klinika - Hematologie
- Principal Investigator Name
- Jan Straub
- Principal Investigator Email
- jan.straub@vfn.cz
- Contact Person Name
- Jan Straub
- Contact Person Email
- jan.straub@vfn.cz
Greece
- Earliest CTIS Part Ii Submission Date
- 29-04-2024
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 639
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics
- 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
- Evaggelismos Hospital
- Department Name
- Haematology Department
- Principal Investigator Name
- Sosana Delimpasi
- Principal Investigator Email
- sodeli@yahoo.com
- Contact Person Name
- Sosana Delimpasi
- Contact Person Email
- sodeli@yahoo.com
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- 1st Department of Internal Medicine, Division of Hematology
- Principal Investigator Name
- Evdoxia Hatjiharissi
- Principal Investigator Email
- ehatjiharissi@gmail.com
- Contact Person Name
- Evdoxia Hatjiharissi
- Contact Person Email
- ehatjiharissi@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Department of Internal Medicine- Propaedeutic, Hematology Unit
- Principal Investigator Name
- Vasiliki Pappa
- Principal Investigator Email
- vas_pappa@yahoo.com
- Contact Person Name
- Vasiliki Pappa
- Contact Person Email
- vas_pappa@yahoo.com
Italy
- Earliest CTIS Part Ii Submission Date
- 29-04-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 644
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Department of "Biotecnologie Molecolari e Scienze per la Salute"
- Principal Investigator Name
- Francesca Gay
- Principal Investigator Email
- francesca.gay@unito.it
- Contact Person Name
- Francesca Gay
- Contact Person Email
- francesca.gay@unito.it
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- UOC di 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 Socio Sanitaria Territoriale Ovest Milanese
- Department Name
- Oncology
- Principal Investigator Name
- Alessandro Corso
- Principal Investigator Email
- alessandro.corso@asst-ovestmi.it
- Contact Person Name
- Alessandro Corso
- Contact Person Email
- alessandro.corso@asst-ovestmi.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Ematologia, dipartimento di Medicina Traslazionale e di Precisione
- Principal Investigator Name
- Maria Teresa Petrucci
- Principal Investigator Email
- petrucci@bce.uniroma1.it
- Contact Person Name
- Maria Teresa Petrucci
- Contact Person Email
- petrucci@bce.uniroma1.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Internal Medicine Department
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 13-05-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 630
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Servicio de Hematologia
- Principal Investigator Name
- Gladys Ibarra Fernandez
- Principal Investigator Email
- gibarra@iconcologia.net
- Contact Person Name
- Gladys Ibarra Fernandez
- Contact Person Email
- gibarra@iconcologia.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio de Hematologia
- Principal Investigator Name
- Cristina Encinas Rodriguez
- Principal Investigator Email
- cristina.encinas@salud.madrid.org
- Contact Person Name
- Cristina Encinas Rodriguez
- Contact Person Email
- cristina.encinas@salud.madrid.org
- Site Name
- Complejo Hospitalario Universitario De Ourense
- Department Name
- Servicio de Hematologia
- Principal Investigator Name
- Jose Luis Sastre Moral
- Principal Investigator Email
- jose.luis.sastre.moral@sergas.es
- Contact Person Name
- Jose Luis Sastre Moral
- Contact Person Email
- jose.luis.sastre.moral@sergas.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Servicio de Hematologia
- 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
- Area De Salud De Leon Y El Bierzo
- Department Name
- Servicio de Hematologia
- Principal Investigator Name
- Fernando Escalante Barrigon
- Principal Investigator Email
- fescalanteb@saludcastillayleon.es
- Contact Person Name
- Fernando Escalante Barrigon
- Contact Person Email
- fescalanteb@saludcastillayleon.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de Hematologia
- 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
Denmark
- Earliest CTIS Part Ii Submission Date
- 25-04-2024
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 643
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Odense University Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Charlotte Toftmann Hansen
- Principal Investigator Email
- charlotte.toftmann.hansen2@rsyd.dk
- Contact Person Name
- Charlotte Toftmann Hansen
- Contact Person Email
- charlotte.toftmann.hansen2@rsyd.dk
- Site Name
- Lillebaelt Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Katrine Fladeland Iversen
- Principal Investigator Email
- katrine.fladeland.iversen@rsyd.dk
- Contact Person Name
- Katrine Fladeland Iversen
- Contact Person Email
- katrine.fladeland.iversen@rsyd.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 25-04-2024
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 645
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Algemeen Ziekenhuis Klina
- Department Name
- Hematology
- Principal Investigator Name
- Jan Loos
- Principal Investigator Email
- jan.loos@klina.be
- Contact Person Name
- Jan Loos
- Contact Person Email
- jan.loos@klina.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
- Contact Person Email
- jan.vandroogenbroeck@azsintjan.be
Austria
- Earliest CTIS Part Ii Submission Date
- 16-05-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 627
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Department of Hematology and Oncology
- Principal Investigator Name
- Irene Strassl
- Principal Investigator Email
- irene.strassl@ordensklinikum.at
- Contact Person Name
- Irene Strassl
- Contact Person Email
- irene.strassl@ordensklinikum.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- I. Medical Department
- Principal Investigator Name
- Martin Schreder
- Principal Investigator Email
- martin.schreder@gesundheitsverbund.at
- Contact Person Name
- Martin Schreder
- Contact Person Email
- martin.schreder@gesundheitsverbund.at
- Site Name
- Universitaetsklinikum Krems
- Department Name
- Department of Internal Medicine II, Clinical Department of Oncology and Hematology
- Principal Investigator Name
- Klaus Podar
- Principal Investigator Email
- klaus.podar@krems.lknoe.at
- Contact Person Name
- Klaus Podar
- Contact Person Email
- klaus.podar@krems.lknoe.at
- Site Name
- Medical University Of Graz
- Department Name
- Department of Hematology
- Principal Investigator Name
- Katharina Prochazka
- Principal Investigator Email
- katharinatheresa.prochazka@uniklinikum.kages.at
- Contact Person Name
- Katharina Prochazka
- Contact Person Email
- katharinatheresa.prochazka@uniklinikum.kages.at
Poland
- Earliest CTIS Part Ii Submission Date
- 09-05-2024
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 631
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Klinika Hematoonkologii, Transplantacji Szpiku i Chemioterapii
- Principal Investigator Name
- Marek Hus
- Principal Investigator Email
- hematoonkologia@spsk1.lublin.pl
- Contact Person Name
- Marek Hus
- Contact Person Email
- hematoonkologia@spsk1.lublin.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Monika Szarejko
- Principal Investigator Email
- klhem@gumed.edu.pl
- Contact Person Name
- Monika Szarejko
- Contact Person Email
- klhem@gumed.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Nowotworów 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
Sweden
- Earliest CTIS Part Ii Submission Date
- 25-04-2024
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 643
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Region Dalarna
- Department Name
- Falu Lasarett Hematologimottagningen, Medicinkliniken 791 82 Falun
- 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
- NU Hospital Group-Vastra Gotalandsregionen
- Department Name
- Uddevalla Hospital, Department of Medicine, Section of Hematology
- Principal Investigator Name
- Dorota Knut-Bojanowska
- Principal Investigator Email
- dorota.knut@vgregion.se
- Contact Person Name
- Dorota Knut-Bojanowska
- Contact Person Email
- dorota.knut@vgregion.se
- Site Name
- Region Skane Helsingborg Hospital
- Department Name
- Hematology Section
- Principal Investigator Name
- Per Axelsson
- Principal Investigator Email
- Per.Axelsson@skane.se
- Contact Person Name
- Per Axelsson
- Contact Person Email
- Per.Axelsson@skane.se
Hungary
- Earliest CTIS Part Ii Submission Date
- 02-05-2024
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 636
- Number Of Sites
- 3
- Number Of Participants
- 13
Sites
- Site Name
- Semmelweis University
- Department Name
- Belgyogyaszati es Hematologiai Klinika
- Principal Investigator Name
- Gergely Varga
- Principal Investigator Email
- titkarsag.3bel@med.semmelweis-univ.hu
- Contact Person Name
- Gergely Varga
- Contact Person Email
- titkarsag.3bel@med.semmelweis-univ.hu
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- II. Belgyogyaszat – Hematologia
- Principal Investigator Name
- Zsolt Lazar
- Principal Investigator Email
- bel2haematadmin@petz.gyor.hu
- Contact Person Name
- Zsolt Lazar
- Contact Person Email
- bel2haematadmin@petz.gyor.hu
- Site Name
- Semmelweis University (B. epulet)
- Department Name
- Belgyogyaszati es Hematologiai Klinika, B. epulet
- Principal Investigator Name
- Gabor Mikala
- Principal Investigator Email
- titkarsag.3bel@semmelweis.hu
- Contact Person Name
- Gabor Mikala
- Contact Person Email
- titkarsag.3bel@semmelweis.hu
Germany
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 653
- Number Of Sites
- 6
- Number Of Participants
- 9
Sites
- Site Name
- Klinikum Chemnitz gGmbH
- 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
- Centrum für Hämatologie und Onkologie Bethanien
- Principal Investigator Name
- Christian Schmitt
- Principal Investigator Email
- schmitt@onkologie-bethanien.com
- Contact Person Name
- Christian Schmitt
- Contact Person Email
- schmitt@onkologie-bethanien.com
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Principal Investigator Name
- Stephan Bohl
- Principal Investigator Email
- studienzentrum-haema@charite.de
- Contact Person Name
- Stephan Bohl
- Contact Person Email
- studienzentrum-haema@charite.de
- Site Name
- Staedtisches Klinikum Karlsruhe gGmbH
- Principal Investigator Name
- Stefanie Lemnitz
- Principal Investigator Email
- Stefanie.Lemnitz@Klinikum-Karlsruhe.de
- Contact Person Name
- Stefanie Lemnitz
- Contact Person Email
- Stefanie.Lemnitz@Klinikum-Karlsruhe.de
- Site Name
- Medical Center - University Of Freiburg
- Principal Investigator Name
- Monika Engelhardt
- Principal Investigator Email
- monika.engelhardt@uniklinik-freiburg.de
- Contact Person Name
- Monika Engelhardt
- Contact Person Email
- monika.engelhardt@uniklinik-freiburg.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Principal Investigator Name
- Katja Weisel
- Principal Investigator Email
- Onko-Studienzentrum@uke.de
- Contact Person Name
- Katja Weisel
- Contact Person Email
- Onko-Studienzentrum@uke.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 02-05-2024
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 587
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Champalimaud Clinical Centre
- Department Name
- Unidade de Hemato-Oncologia
- Principal Investigator Name
- Manuel Neves
- Principal Investigator Email
- manuel.neves@fundacaochampalimaud.pt
- Contact Person Name
- Manuel Neves
- Contact Person Email
- manuel.neves@fundacaochampalimaud.pt
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Serviço de Hematologia e Transplantação de Medula Ósses
- Principal Investigator Name
- Moreira Claudia
- Principal Investigator Email
- csmoreira@ipoporto.min-saude.pt
- Contact Person Name
- Moreira Claudia
- Contact Person Email
- csmoreira@ipoporto.min-saude.pt
- Site Name
- Hospital De Santa Maria E.P.E.
- Department Name
- Serviço de Hematologia e Transplantação de Medula
- Principal Investigator Name
- Joana Vieira
- Principal Investigator Email
- vieira_joana@hotmail.com
- Contact Person Name
- Joana Vieira
- Contact Person Email
- vieira_joana@hotmail.com
France
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 642
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Centre Hospitalier Regional D'Orleans
- Department Name
- Service d'hématologie
- Principal Investigator Name
- Omar Benbrahim
- Principal Investigator Email
- omar.benbrahim@chu-orleans.fr
- Contact Person Name
- Omar Benbrahim
- Contact Person Email
- omar.benbrahim@chu-orleans.fr
- Site Name
- Centre Hospitalier D Avignon
- Department Name
- Service d'onco-hématologie
- Principal Investigator Name
- Thierry Takam
- Principal Investigator Email
- takam.thierry@ch-avignon.fr
- Contact Person Name
- Thierry Takam
- Contact Person Email
- takam.thierry@ch-avignon.fr
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- Centre de cancérologie de la Sarthe
- Principal Investigator Name
- Kamel Laribi
- Principal Investigator Email
- klaribi@ch-lemans.fr
- Contact Person Name
- Kamel Laribi
- Contact Person Email
- klaribi@ch-lemans.fr
- Site Name
- Centre Hospitalier De Saint-Quentin
- Department Name
- Service d'onco-hématologie
- Principal Investigator Name
- Malek Bouketouche
- Principal Investigator Email
- m.bouketouche@ch-stquentin.fr
- Contact Person Name
- Malek Bouketouche
- Contact Person Email
- m.bouketouche@ch-stquentin.fr
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Endpoint Clinical Inc.
- Responsibilities
- code:3
- Name
- Cytel Inc.
- Responsibilities
- DSMB Data Monitoring Committee
Third parties
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Abbvie Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Patient Advertising Guru Inc.","duties_or_roles":"Patient Recruitment Services","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"DSMB Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"AbbVie Deutschland GmbH & Co. KG","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Travel Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Etentamig
- Active Substance
- ETENTAMIG
- Modality
- Bispecific antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
Related trials
Other published trials that may interest you.