Clinical trial • Phase III • Oncology|Haematology

BELANTAMAB MAFODOTIN for Multiple myeloma

Phase III trial of BELANTAMAB MAFODOTIN for Multiple myeloma.

Overview

Trial Therapeutic Area: Oncology|Haematology
Trial Disease: Multiple myeloma
Trial Stage: Phase III
Drug Modality: ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date: 09-12-2024
First CTIS Authorization Date: 22-04-2025

Trial design

Randomised, open-label, daratumumab (darzalex 1800 mg solution for injection) in combination with lenalidomide and dexamethasone (drd). lenalidomide (products listed, up to 25 mg daily as per product entries) and dexamethasone (products listed, up to 40 mg daily as per product entries). schedule details are not specified in the available record.-controlled Phase III trial in Italy, Belgium, Greece and others.

Randomised: Yes
Open Label: Yes
Comparator: Daratumumab (DARZALEX 1800 mg solution for injection) in combination with lenalidomide and dexamethasone (DRd). Lenalidomide (products listed, up to 25 mg daily as per product entries) and dexamethasone (products listed, up to 40 mg daily as per product entries). Schedule details are not specified in the available record.
Target Sample Size: 331

Eligibility

Recruits 331 The trial record indicates 'isVulnerablePopulationSelected': true. Participants must be at least 18 years old and 'Capable of giving signed informed consent as described in Section 10.1.3'. Consent must be provided by the participant (no assent procedures for minors are specified). Multiple informed consent documents and language versions are provided; specific assent/guardian consent processes are not described in the available record..

Pregnancy Exclusion: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
Vulnerable Population: The trial record indicates 'isVulnerablePopulationSelected': true. Participants must be at least 18 years old and 'Capable of giving signed informed consent as described in Section 10.1.3'. Consent must be provided by the participant (no assent procedures for minors are specified). Multiple informed consent documents and language versions are provided; specific assent/guardian consent processes are not described in the available record.

Inclusion criteria

{"criterion_text":"-1. Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.\n-2. Capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n-3. Newly diagnosed MM with a requirement for treatment as documented per IMWG criteria. a) Monoclonal plasma cells in the BM ≥10% or presence of a biopsy proven plasmacytoma and documented MM satisfying at least 1 of the CRAB criteria. CRAB criteria: Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than ULN or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinine CL <40 mL/min or serum creatinine >177 μmol/L (>2 mg/dL); Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: 1 or more osteolytic lesions on skeletal radiography, CT), or PETCT. OR b) Biomarkers of malignancy criteria: Clonal BM plasma cell percentage ≥60%; Involved: uninvolved serum FLC ratio ≥100; >1 focal lesion on MRI studies.\n-4. Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following: a) Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours). And/or b) Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L) And/or c) Serum FLC assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).\n-5.\tNewly diagnosed and not considered candidate for high dose chemotherapy with ASCT due to any of the following: a)\tExclusion from treatment with ASCT due to country- or site-specific age restriction. b)\tPresence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT.\n-6. ECOG performance status of 0 to 2.\n-7. Adequate organ system function as defined by the laboratory assessments listed in the protocol inclusion criteria.\n-8. Male participants: • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. • Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm: -Refrain from donating fresh unwashed semen PLUS either: • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR • Must agree to use contraception/barrier as detailed below • Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.\n-9. Female participants • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: -Is not a WOCBP OR -Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the Treatment Period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. -A WOCBP must have 2 negative highly sensitive serum pregnancy tests before starting treatment, the first may be performed within 14 days from C1D1, the second within 24 hours before the first dose of study intervention. -Should pregnancy occur in a female on-treatment or the female partner of a male on-treatment, treatment must be stopped, and it is advised to seek advice from a physician specialized or experienced in teratology."}

Exclusion criteria

{"criterion_text":"-1. Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom’s disease, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or Primary Plasma Cell Leukemia (defined as circulating plasma cells >5%).\n-10. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention unless the participant can meet the following criteria: a) RNA test negative. b) Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks.\n-11. Participants with hepatitis B will be excluded unless the following criteria can be met: (i.). HBcAb+, HBsAg- (Screening: HBV DNA undetectable, During Study Intervention: Monitoring per protocol, Antiviral treatment instituted if HBV DNA becomes detectable), (ii.). HBsAg+ at screen or within 3 months prior to first dose (Screening: HBV DNA undetectable, highly effective antiviral treatment started at least 4 weeks prior to first dose of study intervention, baseline imaging per protocol, participants with cirrhosis are excluded; During Study Intervention: Antiviral treatment maintained throughout study intervention, monitoring and management per protocol)\n-12. Current corneal epithelial disease except for mild punctate keratopathy.\n-13. Intolerance or contraindications to antiviral prophylaxis.\n-14. Unable to tolerate antithrombotic prophylaxis.\n-15. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study intervention.\n-16. Plasmapheresis within 7 days prior to the first dose of study intervention.\n-17. Participants must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.\n-2. Prior systemic therapy for MM, or smoldering MM.\n-3. Signs of meningeal or central nervous system involvement with MM.\n-4. Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery. Kyphoplasty is not considered major surgery.\n-5. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.\n-6. Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the investigator's assessment).\n-7. Participants with previous or concurrent malignancies other than MM are excluded.\n-8. Evidence of cardiovascular risk including any of the following: a) Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular block. b) Recent history (within 3 months of screening) of MI, acute coronary syndromes (including unstable angina), coronary angioplasty or stenting, or bypass grafting. c) Class III or IV heart failure as defined by the NYHA functional classification system.\n-9. Known HIV infection, unless the participant can meet all of the following criteria: a) Established ART for at least 4 weeks and HIV viral load <400 copies/mL within Screening Period. b) CD4+ T-cell (CD4+) counts ≥350 cells/μL. c) No history of AIDS-defining opportunistic infections within the last 12 months."}

Endpoints

Primary endpoints

{"endpoint_text":"-PFS, defined as the time from the date of randomization to the date of first documented disease progression per IMWG criteria by IRC or death from any cause in the absence of progression, whichever occurs first","definition_or_measurement_approach":"PFS is measured from randomization until first documented disease progression per IMWG criteria assessed by Independent Review Committee (IRC) or death from any cause in the absence of progression; whichever occurs first."}
{"endpoint_text":"-MRD negative status, defined as achieving MRD negativity at 10-5 sensitivity threshold assessed by NGS at least once during the time of confirmed CR or better response per IMWG criteria by IRC","definition_or_measurement_approach":"MRD negativity assessed by next-generation sequencing (NGS) at a sensitivity threshold of 10^-5, achieved at least once during the period of confirmed CR or better per IMWG criteria as determined by the IRC."}

Secondary endpoints

{"endpoint_text":"-PFS2, defined as the time from the date of randomization to the date of documented disease progression following the first subsequent antimyeloma therapy or death from any cause, whichever is earlier","definition_or_measurement_approach":"PFS2 measured from randomization to documented disease progression after first subsequent antimyeloma therapy or death, whichever occurs first."}
{"endpoint_text":"-OS, defined as the time from the date of randomization until the date of death due to any cause","definition_or_measurement_approach":"Overall survival measured from randomization until death from any cause."}
{"endpoint_text":"-CR+, defined as confirmed CR or sCR per IMWG criteria by IRC","definition_or_measurement_approach":"Confirmed complete response (CR) or stringent CR (sCR) assessed per IMWG criteria by IRC."}
{"endpoint_text":"-VGPR+, defined as confirmed VGPR, CR, sCR per IMWG criteria by IRC","definition_or_measurement_approach":"Confirmed very good partial response (VGPR), CR, or sCR per IMWG criteria by IRC."}
{"endpoint_text":"-sMRD, defined as achieving MRD negative status at 10-5 sensitivity threshold assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR or better response per IMWG criteria by IRC","definition_or_measurement_approach":"Sustained MRD negativity (sMRD) assessed by NGS at 10^-5 at least twice ≥1 year apart with no intervening MRD-positive result, during confirmed CR or better per IMWG by IRC."}
{"endpoint_text":"-DoR, defined as the time from first documented evidence of PR or better until PD or death due to PD (among participants who achieve confirmed PR+ by IRC)","definition_or_measurement_approach":"Duration of Response measured from first documented PR or better until disease progression or death due to progression among participants with confirmed PR+ by IRC."}
{"endpoint_text":"-TTST, defined as time from randomization until the date of start of second subsequent line of antimyeloma therapy (irrespective of PD) or death due to any cause, whichever is earlier","definition_or_measurement_approach":"Time to start of second subsequent therapy (TTST) measured from randomization to start date of 2nd subsequent antimyeloma therapy or death, whichever earlier."}
{"endpoint_text":"-Incidence and severity of AEs and SAEs","definition_or_measurement_approach":"Adverse events (AEs) and serious adverse events (SAEs) recorded and graded per protocol-specified safety reporting; incidence and severity summarized."}
{"endpoint_text":"-Incidence of AEs leading to dose modifications or study intervention discontinuation","definition_or_measurement_approach":"Counts and rates of AEs that result in dose modifications or discontinuation of study intervention."}
{"endpoint_text":"-Incidence and severity of ocular findings on ophthalmic exam (changes in VA and corneal findings)","definition_or_measurement_approach":"Ophthalmic examinations documenting visual acuity (VA) changes and corneal findings; incidence and severity summarized."}
{"endpoint_text":"-Maximum post-baseline PRO-CTCAE score for each item attribute","definition_or_measurement_approach":"Patient-reported outcomes using PRO-CTCAE; maximum post-baseline score per item recorded."}
{"endpoint_text":"-Change from baseline in HRQoL as measured by EORTC QLQ-C30.","definition_or_measurement_approach":"Health-related quality of life change from baseline measured using EORTC QLQ-C30 instrument."}
{"endpoint_text":"-Change from baseline in HRQoL as measured by EORTC QLQ-MY20 (Disease Symptoms domain)","definition_or_measurement_approach":"Change from baseline in disease symptoms domain of EORTC QLQ-MY20."}
{"endpoint_text":"-Plasma concentrations of belantamab mafodotin","definition_or_measurement_approach":"Pharmacokinetic assessments: plasma concentrations of belantamab mafodotin measured per PK schedule."}

Recruitment

Digital Remote Recruitment: True, digital/remote methods described in recruitment documents include online postings, an informational website, digital outreach packages and participant recruitment digital outreach materials; materials exist in multiple local language versions for participating countries.
Planned Sample Size: 331
Recruitment Window Months: 67
Consent Approach: Informed consent must be provided in writing by the participant (participants must be capable of giving signed informed consent as per Section 10.1.3). Multiple subject information and informed consent form (ICF) documents are provided (L1_SIS-ICF_Main and numerous country/language-specific ICFs) including addenda for genetic research, pregnant participants, optional interviews and other specific consents. Consent materials are available in multiple languages (English and several local language versions are present in the document set). No assent procedures for minors are specified (minimum age 18).

Methods

Digital outreach and online postings (documents titled 'Digital Outreach', 'Online Postings', 'Participant Recruitment Digital Outreach', 'Digital Recruit Package InfoWebsite')
Information website / InfoWebsite materials (documents titled 'InfoWebsite', 'Digital RegPkg InfoWebsite')
Advocacy factsheet and brochures (documents titled 'Advocacy Factsheet', 'Brochure')
Printed materials: flyers, posters (documents titled 'Flyer', 'Poster')
Patient letters and participant invitation materials (documents titled 'Patient Letter', 'Patient Letter_FP')
Informed consent support materials including ICF Flipbook and ICF process documents (documents titled 'ICF Flipbook', 'Recruit-ICF process', and multiple L1_SIS-ICF documents)
Multilingual/localised recruitment materials (multiple country-specific recruitment documents and translations are present for different Member States)

Geography

Total Number Of Sites: 62
Total Number Of Participants: 225

Italy

Earliest CTIS Part Ii Submission Date: 13-03-2025
Latest Decision Or Authorization Date: 16-10-2025
Processing Time Days: 217
Number Of Sites: 9
Number Of Participants: 30

Sites

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

Site Name: Azienda Ospedaliero Universitaria Pisana
Department Name: UO Hematology
Principal Investigator Name: Gabriele Buda
Principal Investigator Email: ga.buda@libero.it
Contact Person Name: Gabriele Buda
Contact Person Email: ga.buda@libero.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: Dipartimento Malattie Oncologiche e Ematologiche
Principal Investigator Name: Elena Zamagni
Principal Investigator Email: e.zamagni@unibo.it
Contact Person Name: Elena Zamagni
Contact Person Email: e.zamagni@unibo.it

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

Site Name: Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name: Divisione CLinicizzata di Ematologia e TMO
Principal Investigator Name: Francesco Di Raimondo
Principal Investigator Email: Francesco.diraimondo@unict.it
Contact Person Name: Francesco Di Raimondo
Contact Person Email: Francesco.diraimondo@unict.it

Site Name: Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name: Hematology Unit Division/Oncology Department
Principal Investigator Name: Sara Bringhen
Principal Investigator Email: sbringhen@cittadellasalute.to.it
Contact Person Name: Sara Bringhen
Contact Person Email: sbringhen@cittadellasalute.to.it

Site Name: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name: Hematology Unit
Principal Investigator Name: Claudio Cerchione
Principal Investigator Email: Claudio.cerchione@irst.emr.it
Contact Person Name: Claudio Cerchione
Contact Person Email: Claudio.cerchione@irst.emr.it

Site Name: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name: Hematology Unit
Principal Investigator Name: Cirino Botta
Principal Investigator Email: cirino.botta@unipa.it
Contact Person Name: Cirino Botta
Contact Person Email: cirino.botta@unipa.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@policlinicoumberto1.it
Contact Person Name: Maria Teresa Petrucci
Contact Person Email: petrucci@policlinicoumberto1.it

Belgium

Earliest CTIS Part Ii Submission Date: 08-04-2025
Latest Decision Or Authorization Date: 06-10-2025
Processing Time Days: 181
Number Of Sites: 5
Number Of Participants: 12

Sites

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

Site Name: Algemeen Ziekenhuis Delta
Department Name: Hematology
Principal Investigator Name: Rutger Callens
Principal Investigator Email: Rutger.callens@azdelta.be
Contact Person Name: Rutger Callens
Contact Person Email: Rutger.callens@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: Centre Hospitalier EPICURA
Department Name: Hematology
Principal Investigator Name: Julien Depaus
Principal Investigator Email: Julien.depaus@epicura.be
Contact Person Name: Julien Depaus
Contact Person Email: Julien.depaus@epicura.be

Site Name: Cliniques Universitaires Saint-Luc
Department Name: Hematology
Principal Investigator Name: Marie-Christiane Vekemans
Principal Investigator Email: Marie-christiane.vekemans@uclouvain.be
Contact Person Name: Marie-Christiane Vekemans
Contact Person Email: Marie-christiane.vekemans@uclouvain.be

Greece

Earliest CTIS Part Ii Submission Date: 16-01-2025
Latest Decision Or Authorization Date: 13-10-2025
Processing Time Days: 270
Number Of Sites: 6
Number Of Participants: 54

Sites

Site Name: Alexandra Hospital
Department Name: Department of Clinical Therapeutics, National & Kapodistrian University of Athens
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 Alexandroupoli
Department Name: Department of Hematology
Principal Investigator Name: Emmanouil Spanoudakis
Principal Investigator Email: espanoud@med.duth.gr
Contact Person Name: Emmanouil Spanoudakis
Contact Person Email: espanoud@med.duth.gr

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: General University Hospital Of Patras
Department Name: Hematology Department – Bone Marrow Transplantation Unit
Principal Investigator Name: Alexandros Spyridonidis
Principal Investigator Email: gcppatras@gmail.com
Contact Person Name: Alexandros Spyridonidis
Contact Person Email: gcppatras@gmail.com

Site Name: University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name: 2nd Propaedeutic Internal Medicine Clinic - Hematology Department
Principal Investigator Name: Vasiliki Pappa
Principal Investigator Email: vaspappa@med.uoa.gr
Contact Person Name: Vasiliki Pappa
Contact Person Email: vaspappa@med.uoa.gr

Site Name: Theageneio Cancer Hospital
Department Name: Hematology Oncology Department
Principal Investigator Name: Eirini Katodritou
Principal Investigator Email: eirinikatodritou@gmail.com
Contact Person Name: Eirini Katodritou
Contact Person Email: eirinikatodritou@gmail.com

Ireland

Earliest CTIS Part Ii Submission Date: 07-03-2025
Latest Decision Or Authorization Date: 08-09-2025
Processing Time Days: 185
Number Of Sites: 3
Number Of Participants: 11

Sites

Site Name: University Hospital Galway
Department Name: Haematology department
Principal Investigator Name: Janusz Krawczyk
Principal Investigator Email: janusz.krawczyk@universityofgalway.ie
Contact Person Name: Janusz Krawczyk
Contact Person Email: janusz.krawczyk@universityofgalway.ie

Site Name: University Hospital Waterford
Department Name: Haematology department
Principal Investigator Name: Senthil Kumar
Principal Investigator Email: Senthil.Kumar@hse.ie
Contact Person Name: Senthil Kumar
Contact Person Email: Senthil.Kumar@hse.ie

Site Name: Beaumont Hospital
Department Name: Haematology department
Principal Investigator Name: John Quinn
Principal Investigator Email: keithegan2@beaumont.ie
Contact Person Name: John Quinn
Contact Person Email: keithegan2@beaumont.ie

Germany

Earliest CTIS Part Ii Submission Date: 28-03-2025
Latest Decision Or Authorization Date: 24-09-2025
Processing Time Days: 180
Number Of Sites: 9
Number Of Participants: 19

Sites

Site Name: University Hospital Cologne AöR
Department Name: Klinik I für Innere Medizin
Principal Investigator Name: Udo Holtick
Principal Investigator Email: udo.holtick@uk-koeln.de
Contact Person Name: Udo Holtick
Contact Person Email: udo.holtick@uk-koeln.de

Site Name: Medizinische Hochschule Hannover
Department Name: Abteilung für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Principal Investigator Name: Annamaria Brioli
Principal Investigator Email: brioli.annamaria@mh-hannover.de
Contact Person Name: Annamaria Brioli
Contact Person Email: brioli.annamaria@mh-hannover.de

Site Name: Universitaetsklinikum Schleswig-Holstein AöR
Department Name: Klinik für Hämatologie und Onkologie
Principal Investigator Name: Cyrus Khandanpour
Principal Investigator Email: cyrus.khandanpour@uksh.de
Contact Person Name: Cyrus Khandanpour
Contact Person Email: cyrus.khandanpour@uksh.de

Site Name: Universitaetsklinikum Wuerzburg AöR
Department Name: Department of Hematology and Oncology
Principal Investigator Name: Martin Kortuem
Principal Investigator Email: kortuem_m@ukw.de
Contact Person Name: Martin Kortuem
Contact Person Email: kortuem_m@ukw.de

Site Name: University Medical Center Hamburg-Eppendorf
Department Name: Abteilung für Onkologie, Hämatologie, BMT und Abteilung für Pneumologie
Principal Investigator Name: Katja Weisel
Principal Investigator Email: k.weisel@uke.de
Contact Person Name: Katja Weisel
Contact Person Email: k.weisel@uke.de

Site Name: Universitaetsklinikum Jena KöR
Department Name: Klinik für Innere Medizin II – Hämatologie/Onkologie
Principal Investigator Name: Olaposi Yomade
Principal Investigator Email: olaposi.yomade@med.uni-jena.de
Contact Person Name: Olaposi Yomade
Contact Person Email: olaposi.yomade@med.uni-jena.de

Site Name: Gemeinschaftspraxis Haematologie Onkologie
Principal Investigator Name: Thomas Illmer
Principal Investigator Email: illmer@onkologie-dresden.net
Contact Person Name: Thomas Illmer
Contact Person Email: illmer@onkologie-dresden.net

Site Name: Klinikum Chemnitz gGmbH
Department Name: Klinik für Innere Medizin III
Principal Investigator Name: Mathias Hänel
Principal Investigator Email: m.haenel@skc.de
Contact Person Name: Mathias Hänel
Contact Person Email: m.haenel@skc.de

Site Name: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name: III. Medizinische Klinik und Poliklinik
Principal Investigator Name: Christian Michel
Principal Investigator Email: christian.michel@uk-gm.de
Contact Person Name: Christian Michel
Contact Person Email: christian.michel@uk-gm.de

Poland

Earliest CTIS Part Ii Submission Date: 04-04-2025
Latest Decision Or Authorization Date: 12-09-2025
Processing Time Days: 161
Number Of Sites: 5
Number Of Participants: 18

Sites

Site Name: Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name: Oddział Hematologiczny
Principal Investigator Name: Aleksandra Butrym
Principal Investigator Email: onkocwbk@zdrowie.walbrzych.pl
Contact Person Name: Aleksandra Butrym
Contact Person Email: onkocwbk@zdrowie.walbrzych.pl

Site Name: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name: Klinika Nowotworów Układu Chłonnego
Principal Investigator Name: Joanna Romejko-Jarosińska
Principal Investigator Email: joanna.romejko-jarosinska@pib-nio.pl
Contact Person Name: Joanna Romejko-Jarosińska
Contact Person Email: joanna.romejko-jarosinska@pib-nio.pl

Site Name: Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name: Oddział Wieloprofilowy Zachowawczy
Principal Investigator Name: Krzysztof Giannopoulos
Principal Investigator Email: cwbk@umlub.pl
Contact Person Name: Krzysztof Giannopoulos
Contact Person Email: cwbk@umlub.pl

Site Name: Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name: Oddział Hematoonkologii i Chorób Wewnętrznych z Pododdziałem Chemioterapii Dziennej
Principal Investigator Name: Paweł Robak
Principal Investigator Email: badania.kliniczne@kopernik.lodz.pl
Contact Person Name: Paweł Robak
Contact Person Email: badania.kliniczne@kopernik.lodz.pl

Site Name: Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name: Oddział Hematoonkologii, Transplantacji Szpiku i Chemioterapii
Principal Investigator Name: Marek Hus
Principal Investigator Email: hematoonkologia@usk1.lublin.pl
Contact Person Name: Marek Hus
Contact Person Email: hematoonkologia@usk1.lublin.pl

Norway

Earliest CTIS Part Ii Submission Date: 07-04-2025
Latest Decision Or Authorization Date: 25-09-2025
Processing Time Days: 171
Number Of Sites: 4
Number Of Participants: 15

Sites

Site Name: Helse Moere Og Romsdal HF
Department Name: Department of Medicine
Principal Investigator Name: Eivind Samstad
Principal Investigator Email: eivind.ottersen.samstad@helse-mr.no
Contact Person Name: Eivind Samstad
Contact Person Email: eivind.ottersen.samstad@helse-mr.no

Site Name: Helse Bergen HF
Department Name: Department of Science
Principal Investigator Name: Galina Tsykunova
Principal Investigator Email: galina.tsykunova@helse-bergen.no
Contact Person Name: Galina Tsykunova
Contact Person Email: galina.tsykunova@helse-bergen.no

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

Site Name: Akershus University Hospital
Department Name: Department of Hematology
Principal Investigator Name: Anette Loken-Eilertsen
Principal Investigator Email: anette.loken.eilertsen@ahus.no
Contact Person Name: Anette Loken-Eilertsen
Contact Person Email: anette.loken.eilertsen@ahus.no

France

Earliest CTIS Part Ii Submission Date: 07-02-2025
Latest Decision Or Authorization Date: 11-09-2025
Processing Time Days: 216
Number Of Sites: 4
Number Of Participants: 15

Sites

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Département d’Hématologie Clinique
Principal Investigator Name: Thorsten Braun
Principal Investigator Email: thorsten.braun@aphp.fr
Contact Person Name: Thorsten Braun
Contact Person Email: thorsten.braun@aphp.fr

Site Name: L'Hopital Prive Du Confluent
Department Name: Département d’Hématologie
Principal Investigator Name: Maud Voldoire
Principal Investigator Email: dr.voldoire@groupeconfluent.fr
Contact Person Name: Maud Voldoire
Contact Person Email: dr.voldoire@groupeconfluent.fr

Site Name: Institut Gustave Roussy
Department Name: Département d’Hématologie
Principal Investigator Name: Alina-Simona Danu
Principal Investigator Email: alina.danu@gustaveroussy.fr
Contact Person Name: Alina-Simona Danu
Contact Person Email: alina.danu@gustaveroussy.fr

Site Name: Centre Hospitalier Et Universitaire De Limoges
Department Name: Département d’Hématologie
Principal Investigator Name: Murielle Roussel
Principal Investigator Email: murielle.roussel@chu-limoges.fr
Contact Person Name: Murielle Roussel
Contact Person Email: murielle.roussel@chu-limoges.fr

Czechia

Earliest CTIS Part Ii Submission Date: 24-03-2025
Latest Decision Or Authorization Date: 03-10-2025
Processing Time Days: 193
Number Of Sites: 2
Number Of Participants: 8

Sites

Site Name: Fakultni Nemocnice Kralovske Vinohrady
Department Name: Hematologicka klinika
Principal Investigator Name: Petr Pavlicek
Principal Investigator Email: petr.pavlicek@fnkv.cz
Contact Person Name: Petr Pavlicek
Contact Person Email: petr.pavlicek@fnkv.cz

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

Spain

Earliest CTIS Part Ii Submission Date: 21-03-2025
Latest Decision Or Authorization Date: 30-09-2025
Processing Time Days: 193
Number Of Sites: 11
Number Of Participants: 36

Sites

Site Name: Hospital General Universitario Gregorio Maranon
Department Name: Hematology Service
Principal Investigator Name: Cristina Encinas Rodríguez
Principal Investigator Email: cristina.encinas@salud.madrid.org
Contact Person Name: Cristina Encinas Rodríguez
Contact Person Email: cristina.encinas@salud.madrid.org

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

Site Name: Hospital Universitario De Salamanca
Department Name: Hematology Service
Principal Investigator Name: María Victoria Mateos Manteca
Principal Investigator Email: mvmateos@usal.es
Contact Person Name: María Victoria Mateos Manteca
Contact Person Email: mvmateos@usal.es

Site Name: Hospital Universitari Vall D Hebron
Department Name: Hematology Service
Principal Investigator Name: Mercedes Gironella Mesa
Principal Investigator Email: mgironella@vhio.net
Contact Person Name: Mercedes Gironella Mesa
Contact Person Email: mgironella@vhio.net

Site Name: University Clinical Hospital Virgen De La Arrixaca
Department Name: Hematology Service
Principal Investigator Name: Valentin Cabañas Perianes
Principal Investigator Email: valentin.cabanas@carm.es
Contact Person Name: Valentin Cabañas Perianes
Contact Person Email: valentin.cabanas@carm.es

Site Name: Institut Catala D'oncologia
Department Name: Hematology Service
Principal Investigator Name: Laura Abril Sabater
Principal Investigator Email: uicico_badalona@iconcologia.net
Contact Person Name: Laura Abril Sabater
Contact Person Email: uicico_badalona@iconcologia.net

Site Name: Hospital Universitario 12 De Octubre
Department Name: Hematology Service
Principal Investigator Name: Joaquín Martínez López
Principal Investigator Email: j.martinez@salud.madrid.org
Contact Person Name: Joaquín Martínez López
Contact Person Email: j.martinez@salud.madrid.org

Site Name: Hospital Universitario Virgen De La Victoria
Department Name: Hematology Service
Principal Investigator Name: Ricarda García Sánchez
Principal Investigator Email: mricarda.garcia.sspa@juntadeandalucia.es
Contact Person Name: Ricarda García Sánchez
Contact Person Email: mricarda.garcia.sspa@juntadeandalucia.es

Site Name: Hospital Ruber Juan Bravo
Department Name: Hematology Service
Principal Investigator Name: María Aranzazu Alonso Alonso
Principal Investigator Email: aranzazu.alonso@quironsalud.es
Contact Person Name: María Aranzazu Alonso Alonso
Contact Person Email: aranzazu.alonso@quironsalud.es

Site Name: Hospital Universitario De Cabuenes
Department Name: Hematology Service
Principal Investigator Name: María Esther González García
Principal Investigator Email: mariaesther.gonzalez@sespa.es
Contact Person Name: María Esther González García
Contact Person Email: mariaesther.gonzalez@sespa.es

Site Name: Hospital Clinico Universitario De Valladolid
Department Name: Hematology Service
Principal Investigator Name: Alfonso García de Coca
Principal Investigator Email: agarciaco@saludcastillayleon.es
Contact Person Name: Alfonso García de Coca
Contact Person Email: agarciaco@saludcastillayleon.es

Austria

Earliest CTIS Part Ii Submission Date: 19-03-2025
Latest Decision Or Authorization Date: 12-09-2025
Processing Time Days: 177
Number Of Sites: 4
Number Of Participants: 7

Sites

Site Name: Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name: 3. Medizinsiche Abteilung
Principal Investigator Name: Agnes List
Principal Investigator Email: agnes.list@oegk.at
Contact Person Name: Agnes List
Contact Person Email: agnes.list@oegk.at

Site Name: Noe LGA Gesundheit Thermenregion GmbH
Department Name: Department of Medicine III, Division of Hematology and Oncology
Principal Investigator Name: Miklos Burian
Principal Investigator Email: miklos.burian@wienerneustadt.lknoe.at
Contact Person Name: Miklos Burian
Contact Person Email: miklos.burian@wienerneustadt.lknoe.at

Site Name: SCRI CCCIT Ges.m.b.H.
Department Name: Universitaetsklinik fuer innere Medizin III Hämatologie, Internistische Onkologie
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: Ordensklinikum Linz GmbH
Department Name: Interne 1 - Hämatologie mit Stammzellentransplantation, Hämostaseologie und medizinische Onkologie
Principal Investigator Name: Irene Strassl
Principal Investigator Email: Irene.strassl@ordensklinikum.at
Contact Person Name: Irene Strassl
Contact Person Email: Irene.strassl@ordensklinikum.at

Sponsor

Primary sponsor

Full Name: Glaxosmithkline Research & Development Limited
Organisation Type: Pharmaceutical company
Country Of Registered Address: United Kingdom

Contract research organisations

Name: IQVIA Laboratories
Responsibilities: sponsorDuties codes: [4]

Name: Icon Clinical Research Limited
Responsibilities: sponsorDuties codes: [1,11,12,13,14,15,2,5,6,7,8,9]; includes sample management and vendor management

Name: PRA Hellas CRO A.E.
Responsibilities: sponsorDuties codes: [1]

Name: Syneos Health Inc.
Responsibilities: sponsorDuties codes: [4]

Third parties

{"country":"United States","full_name":"IQVIA Laboratories","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Health care"}
{"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,11,12,13,14,15,2,5,6,7,8,9]; notes: 'Sample management, Vendor management' present for some duties","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Resolian Bioanalytics","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Industry"}
{"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Qualitymetric Incorporated LLC","duties_or_roles":"sponsorDuties codes: [15]; value: 'Patient interview'","organisation_type":"Pharmaceutical company"}
{"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"sponsorDuties codes: [15]; value: 'Clinical Study Support'","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"Belgium","full_name":"Stefanini","duties_or_roles":"sponsorDuties codes: [15]; value: 'Digital health services'","organisation_type":"Pharmaceutical company"}
{"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: [15]; value: 'Patient reimbursement'","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name: Belantamab mafodotin (sponsor product code: GSK2857916)
Active Substance: BELANTAMAB MAFODOTIN
Modality: ADC
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: prodAuthStatus=1
Starting Dose: 1.9 mg/kg
Maximum Dose: 1.9 mg/Kg

Investigational Product Name: Daratumumab (DARZALEX 1800 mg solution for injection)
Active Substance: DARATUMUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS
Route: SUBCUTANEOUS
Authorisation Status: prodAuthStatus=2 (marketing authorisation present in product entry)
Starting Dose: 1800 mg
Maximum Dose: 1800 mg

Investigational Product Name: Lenalidomide (Revlimid/Zelvina formulations listed)
Active Substance: LENALIDOMIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL
Authorisation Status: prodAuthStatus=2 (marketing authorisation entries present for multiple products)
Starting Dose: 25 mg
Maximum Dose: 25 mg

Investigational Product Name: Dexamethasone (multiple tablet products listed)
Active Substance: DEXAMETHASONE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL
Authorisation Status: prodAuthStatus=2 (marketing authorisation entries present for multiple products)
Starting Dose: 40 mg
Maximum Dose: 40 mg

Combination Treatment: Yes

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