Clinical trial • Phase III • Oncology

Talquetamab for Relapsed or Refractory Multiple Myeloma

Phase III trial of Talquetamab for Relapsed or Refractory Multiple Myeloma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed or Refractory Multiple Myeloma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule | Other
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
29-05-2024
First CTIS Authorization Date
28-06-2024

Trial design

Randomised, daratumumab sc, pomalidomide and dexamethasone (dpd); doses and schedules not specified in the provided data. (study arms also include talquetamab sc + daratumumab sc + pomalidomide (tal-dp) and talquetamab sc + daratumumab sc (tal-d).)-controlled Phase III trial across 60 sites in Belgium, Germany, Poland and others.

Randomised
Yes
Comparator
Daratumumab SC, Pomalidomide and Dexamethasone (DPd); doses and schedules not specified in the provided data. (Study arms also include Talquetamab SC + Daratumumab SC + Pomalidomide (Tal-DP) and Talquetamab SC + Daratumumab SC (Tal-D).)
Target Sample Size
553

Eligibility

Recruits 553 Vulnerable population selected (isVulnerablePopulationSelected = true). Country-specific subject information and informed consent forms (including pregnancy partner ICFs and subject wallet cards) are provided in multiple languages. The clinical trial justification and protocol specify adult participants; no specific assent procedures for minors are provided in the available documents..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Country-specific subject information and informed consent forms (including pregnancy partner ICFs and subject wallet cards) are provided in multiple languages. The clinical trial justification and protocol specify adult participants; no specific assent procedures for minors are provided in the available documents.

Inclusion criteria

  • {"criterion_text":"- Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio\n- Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment\n- Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed\n- Documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimen\n- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment"}

Exclusion criteria

  • {"criterion_text":"- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients\n- Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)\n- Received prior pomalidomide therapy\n- A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug\n- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required\n- Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival","definition_or_measurement_approach":"Not specified in the provided data; progression assessments reference IMWG criteria in the protocol and inclusion/exclusion definitions."}

Recruitment

Planned Sample Size
553
Recruitment Window Months
79
Consent Approach
Informed consent is obtained from participants using country-specific Subject Information Sheets and Informed Consent Forms (multiple versions and addenda present). Pregnancy partner ICFs and subject wallet cards are provided. ICFs are available in multiple languages (examples in the documents: English, French, Dutch, German, Polish, Spanish, Greek, Italian). No specific assent process for minors is provided (trial enrols adult participants).

Geography

Total Number Of Sites
60
Total Number Of Participants
310

Belgium

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
586
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
CHC MontLegia
Department Name
Hémato-oncologie
Principal Investigator Name
Renaud Roufosse
Principal Investigator Email
renaud.roufosse@chc.be
Contact Person Name
Renaud Roufosse
Contact Person Email
renaud.roufosse@chc.be
Site Name
Antwerp University Hospital
Department Name
Hematologie
Principal Investigator Name
Sebastien Anguille
Principal Investigator Email
Sebastien.Anguille@uza.be
Contact Person Name
Sebastien Anguille
Contact Person Email
Sebastien.Anguille@uza.be
Site Name
Jessa Ziekenhuis
Department Name
Hematologie
Principal Investigator Name
Koen Theunissen
Principal Investigator Email
koen.Theunissen@jessazh.be
Contact Person Name
Koen Theunissen
Contact Person Email
koen.Theunissen@jessazh.be
Site Name
Clinique Saint-Pierre
Department Name
Oncologie - Hématologie
Principal Investigator Name
Thierry Connerotte
Principal Investigator Email
thierry.connerotte@cspo.be
Contact Person Name
Thierry Connerotte
Contact Person Email
thierry.connerotte@cspo.be
Site Name
UZ Brussel
Department Name
Hematologie
Principal Investigator Name
Sylvia Faict
Principal Investigator Email
sylvia.faict@uzbrussel.be
Contact Person Name
Sylvia Faict
Contact Person Email
sylvia.faict@uzbrussel.be

Germany

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
588
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Klinik und Poliklinik V, Hämatologie/Onkologie
Principal Investigator Name
Hartmut Goldschmidt
Principal Investigator Email
hartmut.goldschmidt@med.uni-heidelberg.de
Contact Person Name
Hartmut Goldschmidt
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
2. Medizin, Im Ambulanzzentrum 2/EG/R.508
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
Universitaet Leipzig
Department Name
Medizinische Klinik und Poliklinik I - Bereich Haematologie und Zelltherapie
Principal Investigator Name
Simone Heyn
Principal Investigator Email
Simone.Heyn@medizin.uni-leipzig.de
Contact Person Name
Simone Heyn
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Principal Investigator Name
Christoph Scheid
Principal Investigator Email
christoph.scheid@uk-koeln.de
Contact Person Name
Christoph Scheid
Contact Person Email
christoph.scheid@uk-koeln.de

Poland

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
591
Number Of Sites
9
Number Of Participants
79

Sites

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
ohit@cozl.pl
Contact Person Name
Wojciech Legieć
Contact Person Email
ohit@cozl.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Department Name
Klinika Hematologii z Oddziałem Transplantacji Szpiku
Principal Investigator Name
Bogusław Machaliński
Principal Investigator Email
klinhem@pum.edu.pl
Contact Person Name
Bogusław Machaliński
Contact Person Email
klinhem@pum.edu.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 Wróbel
Principal Investigator Email
khn@usk.wroc.pl
Contact Person Name
Tomasz Wróbel
Contact Person Email
khn@usk.wroc.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Agata Tyczyńska
Principal Investigator Email
hematologia@uck.gda.pl
Contact Person Name
Agata Tyczyńska
Contact Person Email
hematologia@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
Paweł Steckiewicz
Principal Investigator Email
hematologia@onkol.kielce.pl
Contact Person Name
Paweł Steckiewicz
Contact Person Email
hematologia@onkol.kielce.pl
Site Name
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Department Name
Oddział Hematologii
Principal Investigator Name
Marcin Rymko
Principal Investigator Email
hematologia@wszz.torun.pl
Contact Person Name
Marcin Rymko
Contact Person Email
hematologia@wszz.torun.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
kontakt.onkologia.katowice@pratia.com
Contact Person Name
Sebastian Grosicki
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Chłonnego
Principal Investigator Name
Joanna Romejko-Jarosińska
Principal Investigator Email
klinikachloniakow@nio.gov.pl
Contact Person Name
Joanna Romejko-Jarosińska
Contact Person Email
klinikachloniakow@nio.gov.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddział hematologii Onkologicznej
Principal Investigator Name
Jacek Krzanowski
Principal Investigator Email
hematologia-sek@szpital-brzozow.pl
Contact Person Name
Jacek Krzanowski

Greece

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
587
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Alexandra Hospital
Department Name
Therapeutic Clinic-Oncology Department of, General Hospital of Athens
Principal Investigator Name
Athanasios - Meletios Dimopoulos
Principal Investigator Email
mdimop@med.uoa.gr
Contact Person Name
Athanasios - Meletios Dimopoulos
Contact Person Email
mdimop@med.uoa.gr
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department - Bone Marrow Transplantation Unit
Principal Investigator Name
Maria Papathanasiou
Principal Investigator Email
ppthsmr@gmail.com
Contact Person Name
Maria Papathanasiou
Contact Person Email
ppthsmr@gmail.com

France

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
591
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology Department
Principal Investigator Name
Philippe MOREAU
Principal Investigator Email
philippe.moreau@chu-nantes.fr
Contact Person Name
Philippe MOREAU
Contact Person Email
philippe.moreau@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Department of Clinical Hematology
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
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Clinical Hematology Department
Principal Investigator Name
Cyrille HULIN
Principal Investigator Email
cyrille.hulin@chu-bordeaux.fr
Contact Person Name
Cyrille HULIN
Contact Person Email
cyrille.hulin@chu-bordeaux.fr
Site Name
Hopital Saint Antoine
Department Name
Hematology Department
Principal Investigator Name
Mohamad MOHTY
Principal Investigator Email
hematosa.urcest.sat@aphp.fr
Contact Person Name
Mohamad MOHTY
Contact Person Email
hematosa.urcest.sat@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Clinical Hematology Department
Principal Investigator Name
Karim BELHADJ
Principal Investigator Email
karim.belhadj@aphp.fr
Contact Person Name
Karim BELHADJ
Contact Person Email
karim.belhadj@aphp.fr
Site Name
Centre Leon Berard
Department Name
Onco-Hematology Department
Principal Investigator Name
Philippe REY
Principal Investigator Email
philippe.rey@lyon.unicancer.fr
Contact Person Name
Philippe REY
Contact Person Email
philippe.rey@lyon.unicancer.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Hematology Department
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

Netherlands

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
586
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hematologie
Principal Investigator Name
Annemiek Broijl
Principal Investigator Email
a.broyl@erasmusmc.nl
Contact Person Name
Annemiek Broijl
Contact Person Email
a.broyl@erasmusmc.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Hematologie
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
Maxima Medisch Centrum
Department Name
Hematologie
Principal Investigator Name
Laurens Nieuwenhuizen
Principal Investigator Email
Laurens.Nieuwenhuizen@mmc.nl
Contact Person Name
Laurens Nieuwenhuizen
Contact Person Email
Laurens.Nieuwenhuizen@mmc.nl

Czechia

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
587
Number Of Sites
4
Number Of Participants
36

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 Hradec Kralove
Department Name
IV. Interni hematologicka klinika
Principal Investigator Name
Jakub Radocha
Principal Investigator Email
RadochaJ@lfhk.cuni.cz
Contact Person Name
Jakub Radocha
Contact Person Email
RadochaJ@lfhk.cuni.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Interni hematologicka klinika
Principal Investigator Name
Petr Pavlicek
Principal Investigator Email
petr.pavlicek@fnkv.cz
Contact Person Name
Petr Pavlicek
Contact Person Email
petr.pavlicek@fnkv.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Principal Investigator Name
Roman Hajek
Principal Investigator Email
roman.hajek@fno.cz
Contact Person Name
Roman Hajek
Contact Person Email
roman.hajek@fno.cz

Spain

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
588
Number Of Sites
13
Number Of Participants
63

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Servicio de Hematología
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 Clinic De Barcelona
Department Name
Servicio de Hematología
Principal Investigator Name
Carlos Fernandez de Larrea
Principal Investigator Email
cfernan1@clinic.cat
Contact Person Name
Carlos Fernandez de Larrea
Contact Person Email
cfernan1@clinic.cat
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Hematología
Principal Investigator Name
Ricarda Garcia Sanche
Principal Investigator Email
ricarda_g@yahoo.es
Contact Person Name
Ricarda Garcia Sanche
Contact Person Email
ricarda_g@yahoo.es
Site Name
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Hematología
Principal Investigator Name
Jordi Lopez Pardo
Principal Investigator Email
MGranell@santpau.cat
Contact Person Name
Jordi Lopez Pardo
Contact Person Email
MGranell@santpau.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Hematología
Principal Investigator Name
Joaquin Martinez Lopez
Principal Investigator Email
jmarti01@med.ucm.es
Contact Person Name
Joaquin Martinez Lopez
Contact Person Email
jmarti01@med.ucm.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Servicio de Hematología
Principal Investigator Name
Maria Jose Moreno Belmonte
Principal Investigator Email
mjmobel9@hotmail.com
Contact Person Name
Maria Jose Moreno Belmonte
Contact Person Email
mjmobel9@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Hematología
Principal Investigator Name
Mercedes Gironella Mesa
Principal Investigator Email
merce.gironella@vallhebron.cat
Contact Person Name
Mercedes Gironella Mesa
Contact Person Email
merce.gironella@vallhebron.cat
Site Name
Hospital Universitario De Leon
Department Name
Servicio de Hematología
Principal Investigator Name
Fernando Escalante Barrigon
Principal Investigator Email
fescalanteb@saludcastillayleon.es
Contact Person Name
Fernando Escalante Barrigon
Site Name
Hospital De Jerez De La Frontera
Department Name
Servicio de Hematología
Principal Investigator Name
Sebastian Garzon
Principal Investigator Email
sebastianf.garzon.sspa@juntadeandalucia.es
Contact Person Name
Sebastian Garzon
Site Name
Hospital Universitario De Salamanca
Department Name
Servicio de Hematología
Principal Investigator Name
Maria Victoria Mateos Manteca
Principal Investigator Email
mvmateos@usal.es
Contact Person Name
Maria Victoria Mateos Manteca
Contact Person Email
mvmateos@usal.es
Site Name
Hospital Universitario De Canarias
Department Name
Servicio de Hematología
Principal Investigator Name
Sunil Lakhwan
Principal Investigator Email
sunillakhwani@hotmail.com
Contact Person Name
Sunil Lakhwan
Contact Person Email
sunillakhwani@hotmail.com
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Servicio de Hematología
Principal Investigator Name
Paz Ribas
Principal Investigator Email
ribas_paz@gva.es
Contact Person Name
Paz Ribas
Contact Person Email
ribas_paz@gva.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Servicio de 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

Italy

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
592
Number Of Sites
13
Number Of Participants
63

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Oncologia Medica ed Ematologia - S.C. di Ematologia
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 Citta Della Salute E Della Scienza Di Torino
Department Name
Divisione di Ematologia
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 Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
U.O.C. di Oncoematologia
Principal Investigator Name
Caterina Patti
Principal Investigator Email
k.patti@villasofia.it
Contact Person Name
Caterina Patti
Contact Person Email
k.patti@villasofia.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
SC Ematologia
Principal Investigator Name
Anna Maria Cafro
Principal Investigator Email
annamaria.cafro@ospedaleniguarda.it
Contact Person Name
Anna Maria Cafro
Site Name
Casa Sollievo Della Sofferenza
Department Name
Unità Operativa di Ematologia
Principal Investigator Name
Antonietta Pia Falcone
Principal Investigator Email
a.falcone@operapadrepio.it
Contact Person Name
Antonietta Pia Falcone
Contact Person Email
a.falcone@operapadrepio.it
Site Name
Azienda Ospedaliera di Padova
Department Name
U.O. Ematologia
Principal Investigator Name
Renato Zambello
Principal Investigator Email
r.zambello@unipd.it
Contact Person Name
Renato Zambello
Contact Person Email
r.zambello@unipd.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 U.O. di 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 IRCCS Policlinico San Matteo
Department Name
UO di Ematologia
Principal Investigator Name
Silvia Mangiacavalli
Principal Investigator Email
silvia_mangiacavalli@hotmail.com
Contact Person Name
Silvia Mangiacavalli
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Ematologia
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 Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica Ematologica
Principal Investigator Name
Massimo Offidani
Principal Investigator Email
m.offidani@ospedaliriuniti.marche.it
Contact Person Name
Massimo Offidani
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
Ematologia Con 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
University Hospital Consorziale Policlinico
Department Name
UOC Medicina Interna e Oncoematologia
Principal Investigator Name
Angelo Vacca
Principal Investigator Email
angelo.vacca@uniba.it
Contact Person Name
Angelo Vacca
Contact Person Email
angelo.vacca@uniba.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Dipartimento di Oncologia Clinica - U.O. di Ematologia
Principal Investigator Name
Angelo Belotti
Principal Investigator Email
ematologia@asst-spedalicivili.it
Contact Person Name
Angelo Belotti

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel China Co. Ltd.
Responsibilities
sponsorDuties code: 6
Name
Almac Clinical Services LLC
Responsibilities
sponsorDuties code: 3
Name
Labcorp Central Laboratory Services LP
Responsibilities
sponsorDuties code: 4
Name
SGS Belgium
Responsibilities
sponsorDuties code: 10
Name
Hematogenix
Responsibilities
sponsorDuties code: 4
Name
Yprime LLC
Responsibilities
sponsorDuties code: 15 (ePRO)

Third parties

  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Pharmaceutical company"}
  • {"country":"Malaysia","full_name":"Hematogenix","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"sponsorDuties code: 15 (ePRO)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"China","full_name":"Parexel China Co. Ltd.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-64407564
Active Substance
Talquetamab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
prodAuthStatus: 1
Orphan Designation
Yes
Maximum Dose
800 µg/Kg (maxDailyDoseAmount as listed)
Investigational Product Name
DARZALEX 1800 mg solution for injection
Active Substance
Daratumumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
prodAuthStatus: 2
Orphan Designation
Yes
Maximum Dose
1800 mg (maxDailyDoseAmount as listed)
Investigational Product Name
Pomalidomide / Imnovid (various strengths listed)
Active Substance
Pomalidomide
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 1 or 2 depending on product entry
Dose Levels
1 mg, 2 mg, 3 mg, 4 mg hard capsules listed as products
Maximum Dose
4 mg (maxDailyDoseAmount as listed)
Investigational Product Name
Dexamethasone (various marketed preparations listed)
Active Substance
Dexamethasone
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2 (marketed products listed)
Maximum Dose
40 mg daily (maxDailyDoseAmount as listed)
Combination Treatment
Yes

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