Clinical trial • Phase III • Oncology

CILTACABTAGENE AUTOLEUCEL for Multiple myeloma

Phase III trial of CILTACABTAGENE AUTOLEUCEL for Multiple myeloma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Multiple myeloma
Trial Stage
Phase III
Drug Modality
Cell therapy | Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
05-03-2024
First CTIS Authorization Date
11-04-2024

Trial design

Randomised, bortezomib, lenalidomide and dexamethasone (vrd) induction followed by lenalidomide and dexamethasone (rd) maintenance; specific doses and schedules not specified in ctis record.-controlled Phase III trial in Norway, Spain, Austria and others.

Randomised
Yes
Comparator
Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by Lenalidomide and Dexamethasone (Rd) maintenance; specific doses and schedules not specified in CTIS record.
Target Sample Size
250

Eligibility

Recruits 250 The CTIS record indicates vulnerable population selection (isVulnerablePopulationSelected: true). Country-specific Subject Information Sheets and Informed Consent Forms are provided (including dedicated 'Pregnant Partner ICF' and 'Future Research ICF' documents). Specific assent procedures for minors are not provided; participants must be ≥18 years so consent is by the adult participant..

Pregnancy Exclusion
6. A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy test (beta-human chorionic gonadotropin) tests prior to starting VRd and must agree to further testing during the study.
Vulnerable Population
The CTIS record indicates vulnerable population selection (isVulnerablePopulationSelected: true). Country-specific Subject Information Sheets and Informed Consent Forms are provided (including dedicated 'Pregnant Partner ICF' and 'Future Research ICF' documents). Specific assent procedures for minors are not provided; participants must be ≥18 years so consent is by the adult participant.

Inclusion criteria

  • {"criterion_text":"- 1. ≥18 years of age\n- 2. Documented diagnosis of MM according to IMWG diagnostic criteria\n- 3. Measurable disease at Screening\n- 4. Not considered for high-dose chemotherapy with autologous stem cell transplant (ASCT)\n- 5. Eastern Cooperative Oncology Group Performance Status grade of 0 or 1 Contraceptive/Barrier Requirements\n- 6. A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy test (beta-human chorionic gonadotropin) tests prior to starting VRd and must agree to further testing during the study.\n- 7. When a woman is of childbearing potential, the participant must commit either to abstaining continuously from heterosexual intercourse or agree to practice 2 methods of reliable birth control simultaneously, ie, one highly effective method of contraception (failure rate of <1% per year when used consistently and correctly; see examples below) and one other effective method (ie, male latex or synthetic condom, diaphragm, or cervical cap).\n- 8. A man must commit either to abstaining continuously from heterosexual intercourse or a man • Who is sexually active with a WOCBP or a pregnant woman must agree to use a barrier method of contraception (eg, latex or synthetic condom with spermicidal foam/gel/film/cream/suppository), without interruption, from the time of signing the informed consent form (ICF) until at least 4 weeks after the last dose of lenalidomide, 3 months after the last dose of bortezomib, 1 year after receiving the conditioning regimen (cyclophosphamide and fludarabine) or 1 year after receiving cilta-cel infusion (whichever is later), even if they have undergone a successful vasectomy. • Should agree to practice contraception according to and for the time frame specified in the global REVLIMID® ( or generic lenalidomide) pregnancy prevention program or equivalent local REVLIMID® (or generic lenalidomide) pregnancy prevention program, whichever is more stringent.\n- 9. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and until at least 4 weeks after the last dose of lenalidomide, 3 months after the last dose of bortezomib, 1 year after receiving the conditioning regimen (cyclophosphamide and fludarabine), or 1 year after receiving cilta-cel infusion (whichever is later)."}

Exclusion criteria

  • {"criterion_text":"- 1. Frailty index of ≥ 2 according to Myeloma Geriatric Assessment score\n- 10. Hepatitis B infection. In the event the infection status is unclear, quantitative levels are necessary to determine the infection status.\n- 11. Hepatitis C infection (defined as anti-hepatitis C virus [HCV] antibody positive or detectable HCV-RNA) or known to have a history of hepatitis C.\n- 12. Participant must not require continuous supplemental oxygen.\n- 13. Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including cyclophosphamide or fludarabine (if known) or any of their excipients, including boron, mannitol, dimethyl sulfoxide.\n- 14. Serious underlying medical condition, such as: • Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection • Active autoimmune disease • Overt clinical evidence of dementia or altered mental status • Any history of Parkinson's disease or other neurodegenerative disorder Prior/Concomitant Medications.\n- 15. Prior treatment with CAR-T therapy directed at any target.\n- 16. Any therapy that is targeted to BCMA.\n- 17. Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids and/or maximum 1 cycle of VRd therapy prior to enrollment. •Radiation therapy for treatment of plasmacytoma within 14 days before enrollment (palliative radiation for pain control secondary to lytic lesion is allowed within 14 days of enrollment). However, if the radiation portal covered ≤5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiation therapy.\n- 2. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study.\n- 3.Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.\n- 4. The following cardiac conditions: • New York Heart Association Stage III or IV congestive heart failure • Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment • History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration • History of severe non-ischemic cardiomyopathy • Screening 12-lead ECG showing a baseline corrected Prolonged corrected QT interval (QTc) >470 msec (for women) and >450 msec (for men), as assessed by 12-lead ECG, except in participants with a pacemaker. • Impaired cardiac function (left ventricular ejection fraction <45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan.\n- 5. Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM.\n- 6.Stroke or seizure within 6 months of signing ICF.\n- 7.Plasma cell leukemia at the time of screening (>2.0 x 10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.\n- 8. Seropositive for human immunodeficiency virus (HIV).\n- 9. Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) with progression defined by IMWG criteria, or death, whichever occurred first.","definition_or_measurement_approach":"Progression defined by IMWG diagnostic criteria; event = progression per IMWG criteria or death (whichever occurs first)."}

Other endpoints

  • {"endpoint_text":"- Biomarker assessments, Immunogenicity assessments, PROs and Cytogenetic assessments","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
250
Recruitment Window Months
175
Consent Approach
Informed consent is obtained from adult participants (≥18 years). Country-specific Subject Information Sheets and Informed Consent Forms are provided for multiple countries and languages (examples in the document list: NO, ES, AT-de, CZ, IE-Eng, DK-dan, GR-gre, SE-swe, BE [dut/fre], NL, DE, PL, FR, PT, FI, HU). Additional consent documents include a Pregnant Partner ICF and a Future Research ICF. No assent for minors is provided since minimum age is ≥18.

Geography

Total Number Of Sites
60
Total Number Of Participants
371

Norway

Latest Decision Or Authorization Date
17-04-2024
Number Of Sites
1
Number Of Participants
12

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of hematology
Principal Investigator Name
Ingerid Weum Abrahamsen
Principal Investigator Email
inabra@ous-hf.no
Contact Person Name
Ingerid Weum Abrahamsen
Contact Person Email
inabra@ous-hf.no

Spain

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
11
Number Of Participants
78

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Juan Luis Reguera
Principal Investigator Email
juanl.reguera.sspa@juntadeandalucia.es
Contact Person Name
Juan Luis Reguera
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Cecilia Carpio
Principal Investigator Email
ccarpio@vhio.net
Contact Person Name
Cecilia Carpio
Contact Person Email
ccarpio@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Hematologia
Principal Investigator Name
Paula Rodriguez
Principal Investigator Email
paurodriguez@unav.es
Contact Person Name
Paula Rodriguez
Contact Person Email
paurodriguez@unav.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Javier de la Rubia
Principal Investigator Email
delarubia_jav@gva.es
Contact Person Name
Javier de la Rubia
Contact Person Email
delarubia_jav@gva.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Principal Investigator Name
Cristina Encinas
Principal Investigator Email
cristina.encinas@salud.madrid.org
Contact Person Name
Cristina Encinas
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Anna María Sureda
Principal Investigator Email
asureda@iconcologia.net
Contact Person Name
Anna María Sureda
Contact Person Email
asureda@iconcologia.net
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
hematology
Principal Investigator Name
Valentin Cabañas
Principal Investigator Email
valentin.cabanas@gmail.com
Contact Person Name
Valentin Cabañas
Contact Person Email
valentin.cabanas@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Principal Investigator Name
Javier Briones Mejide
Principal Investigator Email
jbriones@santpau.cat
Contact Person Name
Javier Briones Mejide
Contact Person Email
jbriones@santpau.cat
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Maria Victoria Mateos
Principal Investigator Email
mvmateos@usal.es
Contact Person Name
Maria Victoria Mateos
Contact Person Email
mvmateos@usal.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Principal Investigator Name
Enrique Ocio
Principal Investigator Email
enriquem.ocio@unican.es
Contact Person Name
Enrique Ocio
Contact Person Email
enriquem.ocio@unican.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Joaquin Martinez
Principal Investigator Email
jmarti01@med.ucm.es
Contact Person Name
Joaquin Martinez
Contact Person Email
jmarti01@med.ucm.es

Austria

Latest Decision Or Authorization Date
16-04-2024
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitaetsklinik fuer Innere Medizin III
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
Medical University Of Vienna
Department Name
Klin. Abteilung für Hämatologie und Hämostaseologie
Principal Investigator Name
Maria Theresa Krauth
Principal Investigator Email
maria.krauth@meduniwien.ac.at
Contact Person Name
Maria Theresa Krauth
Contact Person Email
maria.krauth@meduniwien.ac.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Hämatologie & Onkologie
Principal Investigator Name
Irene Strassl
Principal Investigator Email
Irene.Strassl@ordensklinikum.at
Contact Person Name
Irene Strassl

Czechia

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
4
Number Of Participants
33

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. Interni klinika - klinika hematologie
Principal Investigator Name
Ivan Spicka
Principal Investigator Email
spicka@cesnet.cz
Contact Person Name
Ivan Spicka
Contact Person Email
spicka@cesnet.cz
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@centrum.cz
Contact Person Name
Jakub Radocha
Contact Person Email
jakub.radocha@centrum.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

Ireland

Latest Decision Or Authorization Date
11-04-2024
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
St James's Hospital
Department Name
Hematology Department
Principal Investigator Name
Christopher Bacon
Principal Investigator Email
lbacon@stjames.ie
Contact Person Name
Christopher Bacon
Contact Person Email
lbacon@stjames.ie

Denmark

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Rigshospitalet
Department Name
Dept of Hematology 2081
Principal Investigator Name
Anne Kaersgaard Mylin
Principal Investigator Email
anne.kaersgaard.mylin@regionh.dk
Contact Person Name
Anne Kaersgaard Mylin
Site Name
Aarhus Universitetshospital
Department Name
Blodsygdomme Klinik
Principal Investigator Name
Maja Oelholm Vase
Principal Investigator Email
majavase@rm.dk
Contact Person Name
Maja Oelholm Vase
Contact Person Email
majavase@rm.dk
Site Name
Odense University Hospital
Department Name
Department of Hematology
Principal Investigator Name
Ida Bruun Kristensen
Principal Investigator Email
Ida.Bruun.Kristensen@rsyd.dk
Contact Person Name
Ida Bruun Kristensen
Contact Person Email
Ida.Bruun.Kristensen@rsyd.dk

Greece

Latest Decision Or Authorization Date
27-05-2024
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department
Principal Investigator Name
Ioanna Sakellari
Principal Investigator Email
ioannamarilena@gmail.com
Contact Person Name
Ioanna Sakellari
Contact Person Email
ioannamarilena@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Dept of Internal Medicine
Principal Investigator Name
Evaggelos Terpos
Principal Investigator Email
eterpos@med.uoa.gr
Contact Person Name
Evaggelos Terpos
Contact Person Email
eterpos@med.uoa.gr
Site Name
Alexandra Hospital
Department Name
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

Sweden

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Hematologiska kliniken
Principal Investigator Name
Stina Wichert
Principal Investigator Email
stina.wichert@skane.se
Contact Person Name
Stina Wichert
Contact Person Email
stina.wichert@skane.se
Site Name
Linkoping University Hospital Region Ostergotland
Department Name
Hematologiska kliniken
Principal Investigator Name
Ingemar Lagerlöf
Principal Investigator Email
Ingemar.Lagerlof@regionostergotland.se
Contact Person Name
Ingemar Lagerlöf

Belgium

Latest Decision Or Authorization Date
18-04-2024
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematologie
Principal Investigator Name
Jan Van Droogenbroeck
Principal Investigator Email
Jan.VanDroogenbroeck@azsintjan.be
Contact Person Name
Jan Van Droogenbroeck
Site Name
Antwerp University Hospital
Department Name
Hematologie
Principal Investigator Name
Sébastien Anguille
Principal Investigator Email
sebastien.anguille@uza.be
Contact Person Name
Sébastien Anguille
Contact Person Email
sebastien.anguille@uza.be

Netherlands

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
3
Number Of Participants
21

Sites

Site Name
Stichting Radboud universitair medisch centrum
Department Name
Hematologie
Principal Investigator Name
Suzanne van Dorp
Principal Investigator Email
secretariaatmanagement.hemat@radboudumc.nl
Contact Person Name
Suzanne van Dorp
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematologie
Principal Investigator Name
Wilfried Roeloffzen
Principal Investigator Email
w.w.h.roeloffzen@umcg.nl
Contact Person Name
Wilfried Roeloffzen
Contact Person Email
w.w.h.roeloffzen@umcg.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hematologie
Principal Investigator Name
Ruth Wester
Principal Investigator Email
secretariaat.hematologie@erasmusmc.nl
Contact Person Name
Ruth Wester

Germany

Latest Decision Or Authorization Date
16-04-2024
Number Of Sites
11
Number Of Participants
54

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik fuer Innere Medizin III
Principal Investigator Name
Daniel Wolff
Principal Investigator Email
Daniel.Wolff@ukr.de
Contact Person Name
Daniel Wolff
Contact Person Email
Daniel.Wolff@ukr.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Abt. f. Innere Medizin II, Haematologie/Onkologie/Rheumatologie
Principal Investigator Name
Britta Besemer
Principal Investigator Email
britta.besemer@med.uni-tuebingen.de
Contact Person Name
Britta Besemer
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik u. Poliklinik
Principal Investigator Name
Eva Wagner-Drouet
Principal Investigator Email
eva.wagner@unimedizin-mainz.de
Contact Person Name
Eva Wagner-Drouet
Contact Person Email
eva.wagner@unimedizin-mainz.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Klinik m. Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
Principal Investigator Name
Stephan Rainer Maximilian Bohl
Principal Investigator Email
Stephan.Bohl@charite.de
Contact Person Name
Stephan Rainer Maximilian Bohl
Contact Person Email
Stephan.Bohl@charite.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik, Onkologie und Haematologie
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 Heidelberg AöR
Department Name
Med. Klinik und Poliklinik V, Haematologie/Onkologie
Principal Investigator Name
Hartmut Goldschmidt
Principal Investigator Email
hartmut.goldschmidt@med.uni-heidelberg.de
Contact Person Name
Hartmut Goldschmidt
Site Name
Universitaet Leipzig
Department Name
Medizinische Klinik und Poliklinik I - Bereich Haematologie und Zelltherapie
Principal Investigator Name
Vladan Vucinic
Principal Investigator Email
Vladan.vucinic@medizin.uni-leipzig.de
Contact Person Name
Vladan Vucinic
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Med. Klinik und Poliklinik III Haematologie/Onkologie
Principal Investigator Name
Sebastian Theurich
Principal Investigator Email
sebastian.theurich@med.uni-muenchen.de
Contact Person Name
Sebastian Theurich
Site Name
Technische Universitaet Dresden
Department Name
Med. Klinik und Poliklinik 1, Haematologische Ambulanz MK1-A1
Principal Investigator Name
Malte von Bonin
Principal Investigator Email
malte.bonin@uniklinikum-dresden.de
Contact Person Name
Malte von Bonin
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Med. Klinik und Poliklinik II, Abt. fuer Onkologie/Haematologie
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
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin I, Haematologie und Onkologie
Principal Investigator Name
Ralph Waesch
Principal Investigator Email
ralph.waesch@uniklinik-freiburg.de
Contact Person Name
Ralph Waesch

Poland

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
6
Number Of Participants
78

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Jan Zaucha
Principal Investigator Email
jan.zaucha@gumed.edu.pl
Contact Person Name
Jan Zaucha
Contact Person Email
jan.zaucha@gumed.edu.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
Oddzial Hematologii i Transplantacji Szpiku
Principal Investigator Name
Wojciech Legiec
Principal Investigator Email
wlegiec@cozl.pl
Contact Person Name
Wojciech Legiec
Contact Person Email
wlegiec@cozl.pl
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Hematologii
Principal Investigator Name
Ewa Lech-Maranda
Principal Investigator Email
emaranda@ihit.waw.pl
Contact Person Name
Ewa Lech-Maranda
Contact Person Email
emaranda@ihit.waw.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
tomasz_wrobel@wp.pl
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz_wrobel@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Hematologii i Transplantaji Szpiku
Principal Investigator Name
Dominik Dytfeld
Principal Investigator Email
dytfeld@me.com
Contact Person Name
Dominik Dytfeld
Contact Person Email
dytfeld@me.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Transplantacji Szpiku i Onkohematologii
Principal Investigator Name
Sebastian Giebel
Principal Investigator Email
Sebastian.Giebel@io.gliwice.pl
Contact Person Name
Sebastian Giebel
Contact Person Email
Sebastian.Giebel@io.gliwice.pl

France

Latest Decision Or Authorization Date
17-04-2024
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology and Cell Therapy
Principal Investigator Name
Xavier Leleu
Principal Investigator Email
xavier.leleu@chu-poitiers.fr
Contact Person Name
Xavier Leleu
Contact Person Email
xavier.leleu@chu-poitiers.fr
Site Name
Hopital Saint Louis
Department Name
Immuno-hematology
Principal Investigator Name
Bertrand Arnulf
Principal Investigator Email
bertrand.arnulf@aphp.fr
Contact Person Name
Bertrand Arnulf
Contact Person Email
bertrand.arnulf@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology
Principal Investigator Name
Aurore Perrot
Principal Investigator Email
perrot.aurore@iuct-oncopole.fr
Contact Person Name
Aurore Perrot
Contact Person Email
perrot.aurore@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hematology
Principal Investigator Name
Salomon Manier
Principal Investigator Email
salomon.manier@chu-lille.fr
Contact Person Name
Salomon Manier
Contact Person Email
salomon.manier@chu-lille.fr

Portugal

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Hematology
Principal Investigator Name
José Mário Mariz
Principal Investigator Email
mariz@ipoporto.min-saude.pt
Contact Person Name
José Mário Mariz
Contact Person Email
mariz@ipoporto.min-saude.pt
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Hematology
Principal Investigator Name
Gilda Teixeira
Principal Investigator Email
gteixeira@ipolisboa.min-saude.pt
Contact Person Name
Gilda Teixeira

Finland

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
University Of Helsinki
Department Name
Comprehensive Cancer Center, Department of Hematology
Principal Investigator Name
Mikko Keranen
Principal Investigator Email
mikko.keranen@hus.fi
Contact Person Name
Mikko Keranen
Contact Person Email
mikko.keranen@hus.fi
Site Name
Oulu University Hospital
Principal Investigator Name
Marjaana Säily
Principal Investigator Email
marjaana.saily@pohde.fi
Contact Person Name
Marjaana Säily
Contact Person Email
marjaana.saily@pohde.fi
Site Name
Turku University Hospital
Principal Investigator Name
Juha Ranti
Principal Investigator Email
juha.ranti@varha.fi
Contact Person Name
Juha Ranti
Contact Person Email
juha.ranti@varha.fi

Hungary

Latest Decision Or Authorization Date
12-04-2024
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Hematologiai es Ossejt-transzplantacios Osztaly
Principal Investigator Name
Gergely Lakatos
Principal Investigator Email
gregory.lakatos@gmail.com
Contact Person Name
Gergely Lakatos
Contact Person Email
gregory.lakatos@gmail.com

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
sponsorDuties codes: [15]; value: 'Finland CRO'

Third parties

  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: 'Finland CRO'","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"sponsorDuties codes: [15]; value: 'IP Supplies'","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"CMT Cellex Manufacturing Transports and Logistics GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CARVYKTI 3.2 × 10^6 – 1.0 × 10^8 cells dispersion for infusion
Active Substance
CILTACABTAGENE AUTOLEUCEL
Modality
Cell therapy
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (EU/1/22/1648/001)
Orphan Designation
Yes
Frequency
Single administration (per protocol objective: single administration of cilta-cel)
Investigational Product Name
Lenalidomide Mylan (various strengths)
Active Substance
LENALIDOMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (multiple MA numbers listed)
Dose Levels
Available strengths in record include 2.5 mg | 5 mg | 10 mg | 15 mg | 20 mg | 25 mg
Investigational Product Name
VELCADE 3.5 mg powder for solution for injection
Active Substance
BORTEZOMIB
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous (reconstituted for injection)
Authorisation Status
Authorised (EU/1/04/274/001)
Investigational Product Name
Dexamethasone Tablets BP 2.0mg / Dexamethason 4 mg JENAPHARM®
Active Substance
DEXAMETHASONE
Modality
Small molecule (corticosteroid)
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketing authorisations listed per product)
Dose Levels
Products listed: 2.0 mg and 4 mg tablet presentations
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule (chemotherapy)
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
FLUDARABINE
Active Substance
FLUDARABINE
Modality
Small molecule (chemotherapy)
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Combination Treatment
Yes

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