Clinical trial • Phase III • Oncology | Haematology

belantamab mafodotin for Relapsed/refractory multiple myeloma | Multiple myeloma

Phase III trial of belantamab mafodotin for Relapsed/refractory multiple myeloma | Multiple myeloma.

Overview

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

Key dates

Initial CTIS Submission Date: 23-04-2024
First CTIS Authorization Date: 10-06-2024

Trial design

Randomised, open-label, treatment arm a (investigational): belantamab mafodotin 2.5 mg/kg iv every 3 weeks to progression; cycles 1–8: bortezomib 1.3 mg/m2 sc on days 1, 4, 8, and 11 of each 21-day cycle; dexamethasone 20 mg (iv or po) on the day of and the day after bortezomib. treatment arm b (comparator): daratumumab 16 mg/kg iv weekly for cycles 1–3 (weeks 1–9; 21-day cycles, total 9 doses), on day 1 of cycles 4–8 (weeks 10–24; 21-day cycles, total 5 doses), then every 4 weeks from cycle 9 (week 25) onwards until progression; for cycles 1–8: bortezomib 1.3 mg/m2 sc on days 1, 4, 8, and 11 of each 21-day cycle; dexamethasone 20 mg (iv or po, iv prior to first daratumumab dose) on the day of and the day after bortezomib.-controlled Phase III trial in France, Netherlands, Germany and others.

Randomised: Yes
Open Label: Yes
Comparator: Treatment Arm A (investigational): Belantamab mafodotin 2.5 mg/kg IV every 3 weeks to progression; Cycles 1–8: bortezomib 1.3 mg/m2 SC on Days 1, 4, 8, and 11 of each 21-day cycle; dexamethasone 20 mg (IV or PO) on the day of and the day after bortezomib. Treatment Arm B (comparator): Daratumumab 16 mg/kg IV weekly for Cycles 1–3 (Weeks 1–9; 21-day cycles, total 9 doses), on Day 1 of Cycles 4–8 (Weeks 10–24; 21-day cycles, total 5 doses), then every 4 weeks from Cycle 9 (Week 25) onwards until progression; For Cycles 1–8: bortezomib 1.3 mg/m2 SC on Days 1, 4, 8, and 11 of each 21-day cycle; dexamethasone 20 mg (IV or PO, IV prior to first daratumumab dose) on the day of and the day after bortezomib.
Target Sample Size: 338

Eligibility

Recruits 338 Vulnerable population not selected. Participants must be adults (18 years or older) and "Capable of giving signed informed consent as described in protocol section 10.1.3"; consent must be provided by the participant. No minors/assent procedures are described in the documentation provided..

Pregnancy Exclusion: Female Participants: Contraceptive use by women should be consistent with local regulations regarding 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 woman of childbearing potential OR Is a woman of childbearing potential and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the intervention period and for 4 months after the last dose of belantamab mafodotin, 3 months from the last dose of daratumumab, and 7 months from the last dose of bortezomib, whichever is longer, 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. Women of childbearing potential must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1. Additional requirements for pregnancy testing during and after study intervention are provided in Section 10.3 and the SoA of the protocol. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Vulnerable Population: Vulnerable population not selected. Participants must be adults (18 years or older) and "Capable of giving signed informed consent as described in protocol section 10.1.3"; consent must be provided by the participant. No minors/assent procedures are described in the documentation provided.

Inclusion criteria

{"criterion_text":"- Capable of giving signed informed consent as described in protocol section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol."}
{"criterion_text":"- Female Participants: Contraceptive use by women should be consistent with local regulations regarding 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 woman of childbearing potential OR Is a woman of childbearing potential and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the intervention period and for 4 months after the last dose of belantamab mafodotin, 3 months from the last dose of daratumumab, and 7 months from the last dose of bortezomib, whichever is longer, 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. Women of childbearing potential must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1. Additional requirements for pregnancy testing during and after study intervention are provided in Section 10.3 and the SoA of the protocol. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. \""}
{"criterion_text":"- 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 from the time of first dose of study until 6 months after the last dose of belantamab mafodotin, and 4 months from the last dose of bortezomib, to allow for clearance of any altered sperm: Refrain from donating sperm 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 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 woman of child bearing potential (including pregnant females)"}
{"criterion_text":"- Male or female, 18 years or older (at the time consent is obtained)"}
{"criterion_text":"- Confirmed diagnosis of multiple myeloma as defined by the IMWG criteria [Rajkumar, 2014]."}
{"criterion_text":"- Previously treated with at least 1 prior line of multiple myeloma therapy, and must have documented disease progression during or after their most recent therapy. \""}
{"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2"}
{"criterion_text":"- Participants with a history of autologous SCT are eligible for study participation provided the following are met: a.\tAutologous stem cell transplant was >100 days prior to initiating study treatment, and b.\tNo active bacterial, viral, or fungal infection(s) present.\""}
{"criterion_text":"- Must have at least ONE aspect of measurable disease, defined as one the following: a.\tUrine M-protein excretion ≥200 mg/24h, or b.\tSerum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or c.\tSerum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65). \""}
{"criterion_text":"- All prior treatment-related toxicities, defined by NCI-CTCAE v5.0, must be ≤ Grade 1 at the time of enrollment, except for alopecia.\""}
{"criterion_text":"- Adequate organ system functions as defined by the following laboratory assessments: Absolute Neutrophil Count: ≥1.0 x 10^9/L Hemoglobin: ≥ 8.0g/dL Platelets: ≥75x109^/L Total bilirubin: ≤1.5xULN; (Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%) Alanine aminotransferase: ≤2.5xULN eGFR: ≥30 mL/min/1.73 m2 Urine dipstick for protein: Negative/trace [if ≥1+, only eligible if confirmed ≤500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void)] OR Albumin/creatinine ratio (from spot urine): ≤500 mg/g (56 mg/mmol) \""}

Exclusion criteria

{"criterion_text":"- Intolerant to daratumumab"}
{"criterion_text":"- Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain"}
{"criterion_text":"- Prior treatment with anti-BCMA therapy\""}
{"criterion_text":"- Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter\""}
{"criterion_text":"- Plasmapheresis within 7 days prior to the first dose of study drug\""}
{"criterion_text":"- Has received radiotherapy to a large pelvic area. Bridging radiotherapy is allowed. NOTE: Disease assessment should be repeated if RT is done prior to first dose of study drug within screening window\""}
{"criterion_text":"- Previous or concurrent malignancies other than multiple myeloma, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. NOTE: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction\""}
{"criterion_text":"- Evidence of cardiovascular risk including any of the following: a.\tEvidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block b.\tHistory of myocardial infarction, acute coronary syndromes, coronary angioplasty, or stenting or bypass grafting within 3 months of Screening c.\tClass III or IV heart failure as defined by the New York Heart Association functional classification system d.\tUncontrolled hypertension \""}
{"criterion_text":"- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, daratumumab, bortezomib, boron or mannitol or any components of the study treatment\""}
{"criterion_text":"- Active infection requiring treatment\""}
{"criterion_text":"- Known HIV infection, unless the participant can meet all of the following criteria: •\tEstablished anti-retroviral therapy for at least 4 weeks and HIV viral load <400 copies/mL •\tCD4+ T-cell (CD4+) counts ≥350 cells/uL •\tNo history of AIDS-defining opportunistic infections within the last 12 months Note: consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant (see protocol Section 6.5.2) \""}
{"criterion_text":"- Prior allogenic stem cell transplant. Participants who have undergone syngeneic transplant are allowed only if no history of GvHD\""}
{"criterion_text":"- Patients with Hepatitis B unless the following criteria can be met: Serology: HBcAb+, HbsAg-: At Screening: •\tHBV DNA undetectable During the study: •\tMonitoring per protocol (Table 18) •\tAntiviral treatment instituted if HBV DNA becomes detectable Serology: HBsAg+ at screen or within 3 months prior to first dose: \t •\tHBV DNA undetectable at Screening •\tHighly effective antiviral treatment started at least 4 weeks prior to first dose of study treatment •\tBaseline imaging per protocol at Screening •\tParticipants with cirrhosis at Screening are excluded\t During the study: •\tAntiviral treatment maintained throughout study treatment •\tMonitoring and management per protocol (Table 18)\""}
{"criterion_text":"- 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 treatment unless the participant can meet the following criteria: •\tRNA test negative •\tSuccessful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks. \""}
{"criterion_text":"- Current corneal epithelial disease except for mild punctate keratopathy \""}
{"criterion_text":"- Intolerance or contraindications to anti-viral prophylaxis.\""}
{"criterion_text":"- Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukaemia at the time of screening.\""}
{"criterion_text":"- Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant’s safety). Participants with isolated proteinuria resulting from MM are eligible, provided all inclusion criteria are met \""}
{"criterion_text":"- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with participant’s safety, obtaining informed consent or compliance to the study procedures \""}
{"criterion_text":"- Evidence of active mucosal or internal bleeding\""}
{"criterion_text":"- Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice. NOTE: stable non-cirrhotic chronic liver disease(including Gilbert’s syndrome or asymptomatic gallstones) is acceptable provided all inclusion criteria are met\""}
{"criterion_text":"- Any major surgery within 4 weeks prior to the first dose of study drug. Exception allowed for bone stabilizing surgery in consultation with medical monitor\""}
{"criterion_text":"- Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment) \""}
{"criterion_text":"- Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m2 twice weekly, or within 60 days of completing that treatment). Participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.\""}

Endpoints

Primary endpoints

{"endpoint_text":"- Progression-Free Survival (PFS), defined as the time from the date of randomization until the earliest date of documented disease progression or death due to any cause","definition_or_measurement_approach":"Progression-Free Survival (PFS) is defined in the protocol as the time from date of randomization to the earliest date of documented disease progression or death due to any cause."}

Secondary endpoints

{"endpoint_text":"- Overall Survival (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 (OS) defined as time from randomization until death due to any cause."}
{"endpoint_text":"- Duration of Response (DoR), defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to any cause","definition_or_measurement_approach":"DoR defined as time from first documented PR or better until PD or death from any cause."}
{"endpoint_text":"- Minimal Residual Disease (MRD) negativity rate, defined as the percentage of participants who are MRD negative by next-generation sequencing (NGS)","definition_or_measurement_approach":"MRD negativity assessed by next-generation sequencing (NGS); endpoint is percentage MRD negative participants."}
{"endpoint_text":"- Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better","definition_or_measurement_approach":"CRR is percentage of participants with confirmed complete response (CR) or better."}
{"endpoint_text":"- Overall Response Rate (ORR), defined as the percentage of participants with a confirmed partial response (PR) or better","definition_or_measurement_approach":"ORR is percentage of participants with confirmed PR or better."}
{"endpoint_text":"- Clinical Benefit Rate (CBR), defined as the percentage of participants with a confirmed minimal response (MR) or better per IMWG","definition_or_measurement_approach":"CBR is percentage of participants with confirmed minimal response (MR) or better as per IMWG criteria."}
{"endpoint_text":"- Time to Response (TTR), defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better","definition_or_measurement_approach":"TTR defined as time from randomization to first documented response (PR or better) among responders."}
{"endpoint_text":"- Time to Progression (TTP), defined as the time from the date of randomization until the earliest date of documented PD or death due to PD","definition_or_measurement_approach":"TTP defined as time from randomization to documented disease progression or death due to PD."}
{"endpoint_text":"- PFS2, defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier.","definition_or_measurement_approach":"PFS2 defined as time from randomization to progression after new anti-myeloma therapy initiation or death, whichever earlier."}
{"endpoint_text":"- If disease progression after new anti-myeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier","definition_or_measurement_approach":"If progression cannot be measured after new therapy, PFS event is date of discontinuation of new anti-myeloma therapy or death, whichever earlier."}
{"endpoint_text":"- Incidence of adverse events (AEs) and changes in laboratory parameters","definition_or_measurement_approach":"Safety endpoints: incidence of AEs (per NCI-CTCAE) and laboratory parameter changes."}
{"endpoint_text":"- Ocular findings on ophthalmic exam","definition_or_measurement_approach":"Ophthalmic examinations to record ocular findings (method per protocol ophthalmic assessments)."}
{"endpoint_text":"- Plasma concentrations of belantamab mafodotin, and cys-mcMMAF","definition_or_measurement_approach":"Pharmacokinetic measurements of plasma concentrations of belantamab mafodotin and cys-mcMMAF (sampling and assays per PK plan)."}
{"endpoint_text":"- Incidence and titers of ADAs against belantamab mafodotin","definition_or_measurement_approach":"Immunogenicity: incidence and titers of anti-drug antibodies (ADAs) to belantamab mafodotin."}
{"endpoint_text":"- Maximum post-baseline PRO-CTCAE score for each item attribute","definition_or_measurement_approach":"Patient-reported outcomes measured by PRO-CTCAE; endpoint is maximum post-baseline score per item."}
{"endpoint_text":"- Change from baseline in HRQOL as measured by EORTC QLQ-C30 and EORTC IL52 (disease symptoms domain from the EORTC QLQ-MY20)","definition_or_measurement_approach":"Change-from-baseline in health-related quality of life measured by EORTC QLQ-C30 and EORTC IL52 (and QLQ-MY20 disease symptoms domain)."}

Recruitment

Planned Sample Size: 338
Recruitment Window Months: 73
Consent Approach: Participants must be capable of giving signed informed consent as described in protocol section 10.1.3. Participants are adults (18 years or older) and provide their own consent. Multiple language versions of the informed consent forms are available (documents in EN, ITA, CZ, FR, DE, EL, IT, NL, PL, ES are listed among ICF documents). Specific ICF addenda (e.g., genetics, optional tumour sample, pregnant partner, restart/rechallenge) are provided as separate documents.

Geography

Total Number Of Sites: 39
Total Number Of Participants: 203

France

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 27-06-2024
Processing Time Days: 45
Number Of Sites: 3
Number Of Participants: 24

Sites

Site Name: Hopital Universitaire Pitie Salpetriere
Department Name: Service d'Hématologie
Principal Investigator Name: Laurent GARDERET
Principal Investigator Email: laurent.garderet@aphp.fr
Contact Person Name: Laurent GARDERET
Contact Person Email: laurent.garderet@aphp.fr

Site Name: Centre Hospitalier Universitaire De Caen Normandie
Department Name: IHBN
Principal Investigator Name: Margaret MACRO
Principal Investigator Email: macro-m@chu-caen.fr
Contact Person Name: Margaret MACRO
Contact Person Email: macro-m@chu-caen.fr

Site Name: Centre Hospitalier Universitaire De Rennes
Department Name: Service d'Hématologie
Principal Investigator Name: Olivier DECAUX
Principal Investigator Email: olivier.decaux@chu-rennes.fr
Contact Person Name: Olivier DECAUX
Contact Person Email: olivier.decaux@chu-rennes.fr

Netherlands

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 14-06-2024
Processing Time Days: 32
Number Of Sites: 2
Number Of Participants: 11

Sites

Site Name: Albert Schweitzer Ziekenhuis
Department Name: Department of Hematology
Principal Investigator Name: Mark-David Levin
Principal Investigator Email: m-d.levin@asz.nl
Contact Person Name: Mark-David Levin
Contact Person Email: m-d.levin@asz.nl

Site Name: Universitair Medisch Centrum Groningen
Department Name: Department of Hematology
Principal Investigator Name: Wilfried W.H. Roeloffzen
Principal Investigator Email: w.w.h.roeloffzen@umcg.nl
Contact Person Name: Wilfried W.H. Roeloffzen
Contact Person Email: w.w.h.roeloffzen@umcg.nl

Germany

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 14-06-2024
Processing Time Days: 32
Number Of Sites: 6
Number Of Participants: 27

Sites

Site Name: Universitaetsklinikum Ulm AöR
Department Name: Innere Medizin III
Principal Investigator Name: Miriam Kull
Principal Investigator Email: miriam.kull@uniklinik-ulm.de
Contact Person Name: Miriam Kull
Contact Person Email: miriam.kull@uniklinik-ulm.de

Site Name: Klinikum der Universitaet Muenchen AöR
Department Name: Studienzentrale fuer Haematologie der Medizinischen Klinik III
Principal Investigator Name: Sebastian Theurich
Principal Investigator Email: sebastian.theurich@med.uni-muenchen.de
Contact Person Name: Sebastian Theurich
Contact Person Email: sebastian.theurich@med.uni-muenchen.de

Site Name: Universitaetsklinikum Duesseldorf AöR
Department Name: Klinik für Haematologie und Onkologie Klinische Immunologie
Principal Investigator Name: Roland Fenk
Principal Investigator Email: roland.fenk@med.uni-duesseldorf.de
Contact Person Name: Roland Fenk
Contact Person Email: roland.fenk@med.uni-duesseldorf.de

Site Name: University Hospital Cologne AöR
Department Name: MED I Studienzentrale CCSG (Cologne Cancer Study Group)
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: Universitaetsklinikum Wuerzburg AöR
Department Name: Med. Klinik und Poliklinik II
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: Universitaetsklinikum Jena KöR
Department Name: Innere Medizin II
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

Italy

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 18-06-2024
Processing Time Days: 36
Number Of Sites: 5
Number Of Participants: 27

Sites

Site Name: Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name: U.O.C. di Ematologia e Trapianto di midollo osseo
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 Degli Spedali Civili Di Brescia
Department Name: U.O. Ematologia
Principal Investigator Name: Angelo Belotti
Principal Investigator Email: ange.belotti@gmail.com
Contact Person Name: Angelo Belotti
Contact Person Email: ange.belotti@gmail.com

Site Name: Azienda Unita Sanitaria Locale Della Romagna
Department Name: U.O. di Ematologia
Principal Investigator Name: Claudia Cellini
Principal Investigator Email: claudia.cellini@auslromagna.it
Contact Person Name: Claudia Cellini
Contact Person Email: claudia.cellini@auslromagna.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: UOC Ematologia
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 Policlinico Universitario Agostino Gemelli IRCCS
Department Name: UOC Servizio e DH Ematologia
Principal Investigator Name: Valerio De Stefano
Principal Investigator Email: valerio.destefano@unicatt.it
Contact Person Name: Valerio De Stefano
Contact Person Email: valerio.destefano@unicatt.it

Poland

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 13-06-2024
Processing Time Days: 31
Number Of Sites: 8
Number Of Participants: 39

Sites

Site Name: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Department Name: Oddział Kliniczny Hematologii i Profilaktyki Chorób Nowotworowych
Principal Investigator Name: Aleksandra Melisz
Principal Investigator Email: aleksandramelisz@gmail.com
Contact Person Name: Aleksandra Melisz
Contact Person Email: aleksandramelisz@gmail.com

Site Name: Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name: Oddział Hematologii i Transplantacji Szpiku
Principal Investigator Name: Wojciech Legieć
Principal Investigator Email: wlegiec@cozl.pl
Contact Person Name: Wojciech Legieć
Contact Person Email: wlegiec@cozl.pl

Site Name: Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
Department Name: Oddział Hematologiczny
Principal Investigator Name: Szymon Fornagiel
Principal Investigator Email: sekretariat@szpitalnowysacz.pl
Contact Person Name: Szymon Fornagiel
Contact Person Email: sekretariat@szpitalnowysacz.pl

Site Name: Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name: Oddział Hematologii, 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: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name: Klinika Nowotworów Układu Chłonnego
Principal Investigator Name: Joanna Romiejko-Jarosińska
Principal Investigator Email: joanna.romejko-jarosinska@nio.gov.pl
Contact Person Name: Joanna Romiejko-Jarosińska
Contact Person Email: joanna.romejko-jarosinska@nio.gov.pl

Site Name: Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name: Oddział Hematologii i Transplantacji Szpiku
Principal Investigator Name: Dominik Dytfeld
Principal Investigator Email: badania.hematologia@usk.poznan.pl
Contact Person Name: Dominik Dytfeld
Contact Person Email: badania.hematologia@usk.poznan.pl

Site Name: Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name: Oddział Hematologii Ogólnej
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: Pratia S.A.
Department Name: Pratia MCM Kraków
Principal Investigator Name: Wojciech Jurczak
Principal Investigator Email: rejestracja.mcm@pratia.com
Contact Person Name: Wojciech Jurczak
Contact Person Email: rejestracja.mcm@pratia.com

Spain

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 10-06-2024
Processing Time Days: 28
Number Of Sites: 7
Number Of Participants: 33

Sites

Site Name: Institut Catala D'oncologia (Badalona)
Department Name: Hematología
Principal Investigator Name: Albert Oriol Rocafiguera
Principal Investigator Email: aoriol@iconcologia.net
Contact Person Name: Albert Oriol Rocafiguera
Contact Person Email: aoriol@iconcologia.net

Site Name: Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name: Hematología
Principal Investigator Name: Anna María Sureda Balari
Principal Investigator Email: asureda@iconcologia.net
Contact Person Name: Anna María Sureda Balari
Contact Person Email: asureda@iconcologia.net

Site Name: Hospital San Pedro De Alcantara
Department Name: Hematología
Principal Investigator Name: Ignacio Casas Aviles
Principal Investigator Email: ignacio.casas@salud-juntaex.es
Contact Person Name: Ignacio Casas Aviles
Contact Person Email: ignacio.casas@salud-juntaex.es

Site Name: Hospital General Universitario Gregorio Maranon
Department Name: Hematología
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 Quironsalud Madrid
Department Name: Hematología
Principal Investigator Name: Carmen Martínez Chamorro
Principal Investigator Email: mcarmen.chamorro@quirosalud.es
Contact Person Name: Carmen Martínez Chamorro
Contact Person Email: mcarmen.chamorro@quirosalud.es

Site Name: Hospital Universitario Rey Juan Carlos
Department Name: Hematología
Principal Investigator Name: Alberto Velasco Valdazo
Principal Investigator Email: alberto.velasco@hospitalreyjuancarlos.es
Contact Person Name: Alberto Velasco Valdazo
Contact Person Email: alberto.velasco@hospitalreyjuancarlos.es

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

Czechia

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 11-06-2024
Processing Time Days: 29
Number Of Sites: 4
Number Of Participants: 15

Sites

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

Site Name: Fakultni Nemocnice Brno
Department Name: Interní hematoonkologická klinika
Principal Investigator Name: Martin Štork
Principal Investigator Email: martin.stork@fnbrno.cz
Contact Person Name: Martin Štork
Contact Person Email: martin.stork@fnbrno.cz

Site Name: Fakultni Nemocnice Hradec Kralove
Department Name: interní hematologická klinika
Principal Investigator Name: Vladimír Maisnar
Principal Investigator Email: vladimir.maisnar@fnhk.cz
Contact Person Name: Vladimír Maisnar
Contact Person Email: vladimir.maisnar@fnhk.cz

Site Name: Vseobecna Fakultni Nemocnice V Praze
Department Name: interní klinika - hematologie
Principal Investigator Name: Ivan Špička
Principal Investigator Email: ivan.spicka@vfn.cz
Contact Person Name: Ivan Špička
Contact Person Email: ivan.spicka@vfn.cz

Greece

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 16-07-2024
Processing Time Days: 64
Number Of Sites: 2
Number Of Participants: 14

Sites

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

Belgium

Earliest CTIS Part Ii Submission Date: 13-05-2024
Latest Decision Or Authorization Date: 14-06-2024
Processing Time Days: 32
Number Of Sites: 2
Number Of Participants: 13

Sites

Site Name: UZ Brussel
Department Name: Hematology
Principal Investigator Name: Rik Schots
Principal Investigator Email: rik.schots@uzbrussel.be
Contact Person Name: Rik Schots
Contact Person Email: rik.schots@uzbrussel.be

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

Sponsor

Primary sponsor

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

Contract research organisations

Name: Iqvia Rds Inc.
Responsibilities: sponsorDuties code: 13

Name: Syneos Health Inc.
Responsibilities: sponsorDuties code: 4

Name: PPD Global Limited
Responsibilities: sponsorDuties codes: 1, 5

Name: Bioclinica Inc.
Responsibilities: sponsorDuties code: 4

Name: Q Squared Solutions LLC
Responsibilities: sponsorDuties code: 4

Name: Quest Diagnostics Nichols Institute Inc.
Responsibilities: sponsorDuties code: 4

Third parties

{"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"reimbursement of the cost of patient’s travel to the sites","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties code: 13","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Matthews Media Group Inc.","duties_or_roles":"Retention materials (value)","organisation_type":"Pharmaceutical company"}
{"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"sponsorDuties codes: 1, 5","organisation_type":"Pharmaceutical company"}
{"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"medicine product destruction","organisation_type":"Pharmaceutical company"}
{"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"in charge of patient fees reimbursement","organisation_type":"Non-Pharmaceutical company"}
{"country":"Greece","full_name":"Affidea Thessaloniki Private Polyclinic Iatriki Monoprosopi S.A.","duties_or_roles":"sponsorDuties codes: 13, 4","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Poland","full_name":"Clinops Tomasz Lusawa","duties_or_roles":"renting equipment (e.g. thermometers or refrigerators to store medications for the duration of the study at sites).","organisation_type":"Industry"}
{"country":"United States","full_name":"International Drug Development Institute Inc.","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"patient tracing","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
{"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"patient fee reimbursement","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United Kingdom","full_name":"Veramed Limited","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: Belantamab mafodotin (GSK2857916)
Active Substance: belantamab mafodotin
Modality: ADC
Routes Of Administration: Intravenous use
Route: Intravenous
Starting Dose: 2.5 mg/kg IV every 3 weeks (Q3W)
Dose Levels: 2.5 mg/kg (initial/only specified dose)
Frequency: Every 3 weeks
Maximum Dose: 15 mg/kg

Investigational Product Name: Daratumumab (DARZALEX 20 mg/mL concentrate for solution for infusion)
Active Substance: daratumumab
Modality: Monoclonal antibody
Routes Of Administration: Intravenous use
Route: Intravenous
Authorisation Status: Authorised (marketing authorisation EU/1/16/1101/002 listed)
Starting Dose: 16 mg/kg IV weekly for Cycles 1–3 (then per protocol schedule)
Frequency: Weekly for Cycles 1–3, then per protocol (every 4 weeks from Cycle 9)

Investigational Product Name: Bortezomib (VELCADE 3.5 mg powder for solution for injection)
Active Substance: bortezomib
Modality: Small molecule
Routes Of Administration: Subcutaneous injection (per protocol; product listing shows intravenous use)
Route: Subcutaneous
Authorisation Status: Authorised (marketing authorisation listed)
Starting Dose: 1.3 mg/m2 SC on Days 1, 4, 8, and 11 of each 21-day cycle (Cycles 1–8)
Frequency: Days 1,4,8,11 of 21-day cycle (Cycles 1–8)
Maximum Dose: 1.3 mg/m2

Investigational Product Name: Dexamethasone (various marketed formulations)
Active Substance: dexamethasone
Modality: Small molecule
Routes Of Administration: Oral or intravenous (per protocol dosing; IV prior to first daratumumab dose)
Route: IV or Oral
Authorisation Status: Authorised (marketed products listed)
Starting Dose: 20 mg (IV or PO) on the day of and the day after bortezomib treatment
Frequency: On day of and day after bortezomib dosing
Maximum Dose: 20 mg (per dosing guidance listed)

Combination Treatment: Yes

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