Clinical trial • Phase III • Oncology|Haematology

TECLISTAMAB for Relapsed/refractory multiple myeloma

Phase III trial of TECLISTAMAB for Relapsed/refractory multiple myeloma.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Relapsed/refractory multiple myeloma
Trial Stage
Phase III
Drug Modality
Bispecific antibody|Small molecule|Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
16-05-2024
First CTIS Authorization Date
02-07-2024

Trial design

Randomised, pomalidomide + bortezomib + dexamethasone (pvd) or carfilzomib + dexamethasone (kd) as control arms (drugs named in title); specific doses and schedules not stated in the ctis metadata Phase III trial in Portugal, Austria, Belgium and others.

Randomised
Yes
Comparator
Pomalidomide + Bortezomib + Dexamethasone (PVd) or Carfilzomib + Dexamethasone (Kd) as control arms (drugs named in title); specific doses and schedules not stated in the CTIS metadata
Target Sample Size
299

Eligibility

Recruits 299 Vulnerable population flag is selected. Subject information sheets and informed consent forms (including Master ICFs, withdrawal ICFs, pregnant partner ICFs, optional future research, genetic ICFs and subject wallet/participation cards) are provided in multiple country-specific languages in the dossier. Consent is documented via site-specific ICFs; no explicit text about assent or parental consent for minors is available in the provided public metadata..

Pregnancy Exclusion
A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
Vulnerable Population
Vulnerable population flag is selected. Subject information sheets and informed consent forms (including Master ICFs, withdrawal ICFs, pregnant partner ICFs, optional future research, genetic ICFs and subject wallet/participation cards) are provided in multiple country-specific languages in the dossier. Consent is documented via site-specific ICFs; no explicit text about assent or parental consent for minors is available in the provided public metadata.

Inclusion criteria

  • {"criterion_text":"- 1. Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (≥)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level ≥200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain ≥10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio"}
  • {"criterion_text":"- 2. Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line"}
  • {"criterion_text":"- 3. Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria"}
  • {"criterion_text":"- 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2"}
  • {"criterion_text":"- 5. A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment"}
  • {"criterion_text":"- 6. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol"}

Exclusion criteria

  • {"criterion_text":"- 1. Received any prior B cell maturation antigen (BCMA)-directed therapy"}
  • {"criterion_text":"- 2. A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (≥) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade ≥3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)"}
  • {"criterion_text":"- 3. Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma"}
  • {"criterion_text":"- 4. Received a live, attenuated vaccine within 4 weeks before randomization"}
  • {"criterion_text":"- 5. Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis"}
  • {"criterion_text":"- 6. Received a maximum cumulative dose of corticosteroids of ≥140 mg of prednisone or equivalent within 14 days prior to randomization"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- progression free survival (PFS)","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
299
Recruitment Window Months
96
Consent Approach
Informed consent is documented using site-specific Subject Information Sheets and Informed Consent Forms (Master ICFs and language-localized ICFs) provided in multiple languages (examples: English, German, French, Spanish, Italian, Portuguese, Dutch, Czech, Polish, Greek, Swedish, Danish). Additional ICFs are provided for pregnant partners, withdrawal, optional future research, genetic consent and privacy appendices. Consent is provided by the participant via the ICF; no public metadata about assent/parental consent for minors is available.

Methods

  • Country/site-based recruitment using recruitment brochures (country-specific PDFs) — e.g., 'Recruitment Brochure' documents listed per member state
  • Caregiver brochures (country-specific) — shown in recruitment materials
  • ICF Flip Chart and site information materials to support recruitment discussions (country-specific)
  • Pre-screening call scripts (documented for Spain) to screen potential participants by phone
  • App-based pre-screening and user app access (documents titled 'User App Access', 'App Questions', 'Content and Ads', 'User App Access') and digital advertising materials ('Content and Ads') listed for some countries
  • Subject wallet/participation cards and brochures provided at sites

Geography

Total Number Of Sites
79
Total Number Of Participants
291

Portugal

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
422
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Serviço de Hematologia
Principal Investigator Name
Isabel Pereira
Principal Investigator Email
isabel.margarida.pereira@hgo.min-saude.pt
Contact Person Name
Isabel Pereira
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Hematologia e Transplantação de Medula Óssea
Principal Investigator Name
Claudia Moreira
Principal Investigator Email
csmoreira@ipoporto.min-saude.pt
Contact Person Name
Claudia Moreira
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Herlander Marques
Principal Investigator Email
herlandermarques@hotmail.com
Contact Person Name
Herlander Marques
Contact Person Email
herlandermarques@hotmail.com
Site Name
Champalimaud Clinical Centre
Department Name
Unidade de Hemato-Oncologia
Principal Investigator Name
Paulo Lúcio
Principal Investigator Email
paulo.lucio@fundacaochampalimaud.pt
Contact Person Name
Paulo Lúcio
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Haematology Department
Principal Investigator Name
Marta Nunes
Principal Investigator Email
marta.soares.nunes@chvng.min-saude.pt
Contact Person Name
Marta Nunes

Austria

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
427
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Medical University Of Vienna
Department Name
Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie
Principal Investigator Name
Maria-Theresa Krauth
Principal Investigator Email
maria.krauth@meduniwien.ac.at
Contact Person Name
Maria-Theresa Krauth
Contact Person Email
maria.krauth@meduniwien.ac.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitaetsklinik für Innere Medizin III, Onkologisches Zentrum
Principal Investigator Name
Thomas Melchardt
Principal Investigator Email
t.melchardt@salk.at
Contact Person Name
Thomas Melchardt
Contact Person Email
t.melchardt@salk.at

Belgium

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
421
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Algemeen Ziekenhuis Klina
Department Name
Hematology
Principal Investigator Name
Jan Loos
Principal Investigator Email
secretariaat.oncologie@klina.be
Contact Person Name
Jan Loos
Site Name
UZ Leuven
Department Name
Hematology
Principal Investigator Name
Michel Delforge
Principal Investigator Email
michel.delforge@uzleuven.be
Contact Person Name
Michel Delforge
Contact Person Email
michel.delforge@uzleuven.be
Site Name
CHU Helora
Department Name
Hematology
Principal Investigator Name
Alain Kentos
Principal Investigator Email
alain.kentos@jolimont.be
Contact Person Name
Alain Kentos
Contact Person Email
alain.kentos@jolimont.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Hematology
Principal Investigator Name
Michelle Pirotte
Principal Investigator Email
Michelle.pirotte@chuliege.be
Contact Person Name
Michelle Pirotte
Contact Person Email
Michelle.pirotte@chuliege.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Hematology
Principal Investigator Name
Alexander Salembier
Principal Investigator Email
hematologie@azgroeninge.be
Contact Person Name
Alexander Salembier
Contact Person Email
hematologie@azgroeninge.be

Denmark

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
421
Number Of Sites
6
Number Of Participants
19

Sites

Site Name
Rigshospitalet
Department Name
Dept. of Hematology, Clinical Trial Unit-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
Klinisk Forskning Blodsygdomme
Principal Investigator Name
Maja Oelholm Vase
Principal Investigator Email
majvas@rm.dk
Contact Person Name
Maja Oelholm Vase
Contact Person Email
majvas@rm.dk
Site Name
Sygehus Lillebaelt Vejle Sygehus
Department Name
Dept. Of Hematology Section of Internal Medicine
Principal Investigator Name
Sarah Farmer
Principal Investigator Email
sarah.farmer1@rsyd.dk
Contact Person Name
Sarah Farmer
Contact Person Email
sarah.farmer1@rsyd.dk
Site Name
Region Midtjylland
Department Name
Klinik for Blodsygdomme Klinisk Forskningsenhed
Principal Investigator Name
Robert Schou Pedersen
Principal Investigator Email
Robert.Schou.Pedersen@goedstrup.rm.dk
Contact Person Name
Robert Schou Pedersen
Site Name
Odense University Hospital
Department Name
Haematologisk Forskningsenhed HFE-X
Principal Investigator Name
Mette Niemann Christoffersen
Principal Investigator Email
mette.n.christoffersen@rsyd.dk
Contact Person Name
Mette Niemann Christoffersen
Contact Person Email
mette.n.christoffersen@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Dept. of Hematology, Clinical Research Unit, Medicinerhuset 2
Principal Investigator Name
Henrik Gregersen
Principal Investigator Email
henrik.gregersen@rn.dk
Contact Person Name
Henrik Gregersen
Contact Person Email
henrik.gregersen@rn.dk

Greece

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
05-08-2025
Processing Time Days
428
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
General Hospital Of Patras Agios Andreas
Department Name
Hematology Department
Principal Investigator Name
Panagiotis Zikos
Principal Investigator Email
pzikos@agandreashosp.gr
Contact Person Name
Panagiotis Zikos
Contact Person Email
pzikos@agandreashosp.gr
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department - Bone Marrow Transplantation Unit
Principal Investigator Name
Michail Iskas
Principal Investigator Email
mic_iskas@yahoo.fr
Contact Person Name
Michail Iskas
Contact Person Email
mic_iskas@yahoo.fr
Site Name
Alexandra Hospital
Department Name
Therapeutic Clinic-Oncology Department of, General Hospital of Athens
Principal Investigator Name
Meletios Dimopoulos
Principal Investigator Email
mdimop@med.uoa.gr
Contact Person Name
Meletios Dimopoulos
Contact Person Email
mdimop@med.uoa.gr

Poland

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
427
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
sgrosicki@wp.pl
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Agata Tyczynska
Principal Investigator Email
atyczynska@uck.gda.pl
Contact Person Name
Agata Tyczynska
Contact Person Email
atyczynska@uck.gda.pl
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Hematologii i Transplantacji Szpiku
Principal Investigator Name
Pawel Steckiewicz
Principal Investigator Email
p.steckiewicz@gmail.com
Contact Person Name
Pawel Steckiewicz
Contact Person Email
p.steckiewicz@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Katedra i Klinika Hematologii i Transplantacji Szpiku
Principal Investigator Name
Marek Hus
Principal Investigator Email
p.steckiewicz@gmail.com
Contact Person Name
Marek Hus
Contact Person Email
p.steckiewicz@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
422
Number Of Sites
4
Number Of Participants
13

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
University Hospital Olomouc
Department Name
Hemato-onkologická klinika
Principal Investigator Name
Tomáš Pika
Principal Investigator Email
Tomas.Pika@fnol.cz
Contact Person Name
Tomáš Pika
Contact Person Email
Tomas.Pika@fnol.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. 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
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Principal Investigator Name
Luděk Pour
Principal Investigator Email
pour.ludek@fnbrno.cz
Contact Person Name
Luděk Pour
Contact Person Email
pour.ludek@fnbrno.cz

Sweden

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
421
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Region Dalarna
Department Name
Medicinkliniken Hematologimottagningen
Principal Investigator Name
Max Flogegard
Principal Investigator Email
Max.Flogegard@regiondalarna.se
Contact Person Name
Max Flogegard
Contact Person Email
Max.Flogegard@regiondalarna.se
Site Name
Uppsala University Hospital
Department Name
KFUE -Blod- och Tumörsjukdomar, Akademiska sjukhuset
Principal Investigator Name
Kristina Carlson
Principal Investigator Email
kristina.carlson@akademiska.se
Contact Person Name
Kristina Carlson
Contact Person Email
kristina.carlson@akademiska.se
Site Name
Region Skane Helsingborg Hospital
Department Name
Hematologimottagningen
Principal Investigator Name
Per Axelsson
Principal Investigator Email
per.axelsson@skane.se
Contact Person Name
Per Axelsson
Contact Person Email
per.axelsson@skane.se

Spain

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
31-07-2025
Processing Time Days
423
Number Of Sites
13
Number Of Participants
48

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Principal Investigator Name
Maria Jesus Blanchard Rodriguez
Principal Investigator Email
mjesusblanchard@yahoo.es
Contact Person Name
Maria Jesus Blanchard Rodriguez
Contact Person Email
mjesusblanchard@yahoo.es
Site Name
Institut Catala D'oncologia
Department Name
Hematology
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
Hospital De Jerez De La Frontera
Department Name
Hematology
Principal Investigator Name
Sebastián Garzón
Principal Investigator Email
sebastianf.garzon.sspa@juntadeandalucia.es
Contact Person Name
Sebastián Garzón
Site Name
Institut Catala D'oncologia (L'Hospitalet)
Department Name
Hematology
Principal Investigator Name
Anna Sureda Balari
Principal Investigator Email
asureda@iconcologia.net
Contact Person Name
Anna Sureda Balari
Contact Person Email
asureda@iconcologia.net
Site Name
Hospital Universitario Infanta Leonor
Department Name
Hematology
Principal Investigator Name
Jose Angel Hernandez Rivas
Principal Investigator Email
jahernandezr@salud.madrid.org
Contact Person Name
Jose Angel Hernandez Rivas
Contact Person Email
jahernandezr@salud.madrid.org
Site Name
Hospital Universitario De Leon
Department Name
Hematology
Principal Investigator Name
Fernando Escalante Barrigon
Principal Investigator Email
fescalanteb@saludcastillayleon.es
Contact Person Name
Fernando Escalante Barrigon
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Joaquín Martinez Lopez
Principal Investigator Email
jmarti01@med.ucm.es
Contact Person Name
Joaquín Martinez Lopez
Contact Person Email
jmarti01@med.ucm.es
Site Name
Hospital Son Llatzer
Department Name
Hematology
Principal Investigator Name
Joan Bargay Lleonart
Principal Investigator Email
jbargay@hsll.es
Contact Person Name
Joan Bargay Lleonart
Contact Person Email
jbargay@hsll.es
Site Name
Complexo Hospitalario Universitario De Pontevedra
Department Name
Hematology
Principal Investigator Name
Ana Maria Dios Loureiro
Principal Investigator Email
ana.maria.dios.loureiro@sergas.es
Contact Person Name
Ana Maria Dios Loureiro
Site Name
Hospital General Universitario Morales Meseguer
Department Name
Hematology
Principal Investigator Name
Felipe de Arriba
Principal Investigator Email
farriba@um.es
Contact Person Name
Felipe de Arriba
Contact Person Email
farriba@um.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Hematology
Principal Investigator Name
Angel Ramirez Payer
Principal Investigator Email
apayer.angel@gmail.com
Contact Person Name
Angel Ramirez Payer
Contact Person Email
apayer.angel@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Javier de la Rubia Comos
Principal Investigator Email
delarubia_jav@gva.es
Contact Person Name
Javier de la Rubia Comos
Contact Person Email
delarubia_jav@gva.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Hematology
Principal Investigator Name
Carmen Martinez-Chamorro
Principal Investigator Email
carmenmartinezchamorro@hotmail.com
Contact Person Name
Carmen Martinez-Chamorro

Netherlands

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
421
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Hematology
Principal Investigator Name
Niels van de Donk
Principal Investigator Email
hematology@amsterdamumc.nl
Contact Person Name
Niels van de Donk
Contact Person Email
hematology@amsterdamumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
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
Meander Medisch Centrum
Department Name
Hematology
Principal Investigator Name
Josien Regelink
Principal Investigator Email
jc.regelink@meandermc.nl
Contact Person Name
Josien Regelink
Contact Person Email
jc.regelink@meandermc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Hematology
Principal Investigator Name
Rimke Oostvogels
Principal Investigator Email
poli-hematologie@umcutrecht.nl
Contact Person Name
Rimke Oostvogels
Contact Person Email
poli-hematologie@umcutrecht.nl

Germany

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
421
Number Of Sites
8
Number Of Participants
33

Sites

Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik Innere Medizin C / Hämatologie und Onkologie
Principal Investigator Name
William Hermann Krueger
Principal Investigator Email
william.krueger@uni-greifswald.de
Contact Person Name
William Hermann Krueger
Site Name
Carl-Thiem-Klinikum Cottbus gGmbH
Department Name
Abteilung für Hämatologie und Onkologie
Principal Investigator Name
Martin Schmidt-Hieber
Principal Investigator Email
m.schmidt_hieber@ctk.de
Contact Person Name
Martin Schmidt-Hieber
Contact Person Email
m.schmidt_hieber@ctk.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Abteilung fuer Innere Medizin II; Hämatologie/Onkologie/Rheumatologie
Principal Investigator Name
Britta Besemer
Principal Investigator Email
britta.besemer@med.uni-tuebingen.de
Contact Person Name
Britta Besemer
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Raphael Teipel
Principal Investigator Email
raphael.teipel@uniklinikum-dresden.de
Contact Person Name
Raphael Teipel
Site Name
Heinrich-Braun-Klinikum Zwickau gGmbH
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Lars-Olof Muegge
Principal Investigator Email
lars-olof.muegge@hbk-zwickau.de
Contact Person Name
Lars-Olof Muegge
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Abteilung Hämatologie und Stammzelltransplantation
Principal Investigator Name
Hans Salwender
Principal Investigator Email
h.salwender@asklepios.com
Contact Person Name
Hans Salwender
Contact Person Email
h.salwender@asklepios.com
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Klinik V; Haematologie,Onkologie
Principal Investigator Name
Marc-Steffen Raab
Principal Investigator Email
marc.raab@med.uni-heidelberg.de
Contact Person Name
Marc-Steffen Raab
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für 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

Italy

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
23-10-2025
Processing Time Days
507
Number Of Sites
10
Number Of Participants
34

Sites

Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Dipartimento Biotecnologie Molecolari e Scienze per la Salute-SC Ematologia U-Università Torino
Principal Investigator Name
Francesca Gay
Principal Investigator Email
francesca.gay@unito.it
Contact Person Name
Francesca Gay
Contact Person Email
francesca.gay@unito.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Ospedale S. Maria della Misericordia - Clinica Ematologica
Principal Investigator Name
Francesca Patriarca
Contact Person Name
Francesca Patriarca
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
SC EMATOLOGIA, 2^ piano PADIGLIONE CORE, viale Risorgimento,80
Principal Investigator Name
Barbara Gamberi
Principal Investigator Email
gamberi.barbara@ausl.re.it
Contact Person Name
Barbara Gamberi
Contact Person Email
gamberi.barbara@ausl.re.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Ematologia U
Principal Investigator Name
Cirino Botta
Principal Investigator Email
cirino.botta@gmail.com
Contact Person Name
Cirino Botta
Contact Person Email
cirino.botta@gmail.com
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Ospedale S. Chiara - UO Ematologia
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
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento Ematologia e Oncologia pediatrica
Principal Investigator Name
Paolo Corradini
Principal Investigator Email
paolo.corradini@unimi.it
Contact Person Name
Paolo Corradini
Contact Person Email
paolo.corradini@unimi.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
UOC Ematologia
Principal Investigator Name
Alessandro Gozzetti
Principal Investigator Email
gozzetti@unisi.it
Contact Person Name
Alessandro Gozzetti
Contact Person Email
gozzetti@unisi.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dipartimento Malattie Oncologiche ed 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
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Ematologia
Principal Investigator Name
Marco Salvini
Principal Investigator Email
marco.salvini@asst-settelaghi.it
Contact Person Name
Marco Salvini
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
UOS Day Hospital ematologico
Principal Investigator Name
Ombretta Annibali
Principal Investigator Email
O.Annibali@policlinicocampus.it
Contact Person Name
Ombretta Annibali

France

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
709
Number Of Sites
12
Number Of Participants
39

Sites

Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hématologie Clinique et Thérapie cellulaire
Principal Investigator Name
Lydia MONTES
Principal Investigator Email
Montes.Lydia@chu-amiens.fr
Contact Person Name
Lydia MONTES
Contact Person Email
Montes.Lydia@chu-amiens.fr
Site Name
Hopital Saint Antoine
Department Name
Service d'Hématologie et de Thérapie cellulaire
Principal Investigator Name
MOHTY Mohamad
Principal Investigator Email
hematosa.urcest.sat@aphp.fr
Contact Person Name
MOHTY Mohamad
Contact Person Email
hematosa.urcest.sat@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
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
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Service d'Hématologie
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
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Oncologie - Hématologie
Principal Investigator Name
Emmanuelle BOURGEOIS
Principal Investigator Email
bourgeois.emmanuelle@ghicl.net
Contact Person Name
Emmanuelle BOURGEOIS
Contact Person Email
bourgeois.emmanuelle@ghicl.net
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service Hématologie
Principal Investigator Name
Clara MARIETTE
Principal Investigator Email
cmariette@chu-grenoble.fr
Contact Person Name
Clara MARIETTE
Contact Person Email
cmariette@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'Hématologie Clinique
Principal Investigator Name
Cyrille TOUZEAU
Principal Investigator Email
cyrille.touzeau@chu-nantes.fr
Contact Person Name
Cyrille TOUZEAU
Contact Person Email
cyrille.touzeau@chu-nantes.fr
Site Name
CHRU De Nancy
Department Name
Hématologie - Medecine interne
Principal Investigator Name
Caroline JACQUET
Principal Investigator Email
c.jacquet@chru-nancy.fr
Contact Person Name
Caroline JACQUET
Contact Person Email
c.jacquet@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Clinical hematology
Principal Investigator Name
Gandhi Laurent DAMAJ
Principal Investigator Email
damaj-gl@chu-caen.fr
Contact Person Name
Gandhi Laurent DAMAJ
Contact Person Email
damaj-gl@chu-caen.fr
Site Name
Assistance Publique Hopitaux De Paris (149 Rue De Sevres)
Department Name
Hématologie Adultes
Principal Investigator Name
Laurent FRENZEL
Principal Investigator Email
laurent.frenzel@aphp.fr
Contact Person Name
Laurent FRENZEL
Contact Person Email
laurent.frenzel@aphp.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Service d'Hématologie
Principal Investigator Name
Kamel LARIBI
Principal Investigator Email
klaribi@ch-lemans.fr
Contact Person Name
Kamel LARIBI
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hématologie Clinique
Principal Investigator Name
Laure VINCENT
Principal Investigator Email
l-vincent@chu-montpellier.fr
Contact Person Name
Laure VINCENT
Contact Person Email
l-vincent@chu-montpellier.fr

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
Regulatory (e.g. preparation of applications to CA and ethics committee) Austria and Greece; other roles indicated by sponsorDuties codes
Name
Parexel China Co. Ltd.
Responsibilities
Responsibilities indicated by sponsorDuties codes (details not textually specified in provided metadata)

Third parties

  • {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"biomarker sample analysis + bone marrow central lab services","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA/ePRO","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"Biomarker sample analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"The Binding Site Group Limited","duties_or_roles":"Biomarker sample analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Regulatory (e.g. preparation of applications to CA and ethics committee) Austria and Greece","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Parexel China Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
teclistamab
Active Substance
TECLISTAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
1
Investigational Product Name
Pomalidomide / Imnovid (various strengths)
Active Substance
POMALIDOMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
1/2
Orphan Designation
Yes
Investigational Product Name
Kyprolis (Carfilzomib)
Active Substance
CARFILZOMIB
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
2
Orphan Designation
Yes
Investigational Product Name
VELCADE (Bortezomib)
Active Substance
BORTEZOMIB
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
2
Investigational Product Name
Dexamethasone (various marketed tablets)
Active Substance
DEXAMETHASONE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Investigational Product Name
Privigen (Human normal immunoglobulin)
Active Substance
HUMAN NORMAL IMMUNOGLOBULIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
2
Combination Treatment
Yes

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