Clinical trial • Phase III • Oncology

TALQUETAMAB for Multiple myeloma | Relapsed or Refractory multiple myeloma

Phase III trial of TALQUETAMAB for Multiple myeloma | Relapsed or Refractory multiple myeloma.

Overview

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

Key dates

Initial CTIS Submission Date
06-10-2023
First CTIS Authorization Date
13-02-2024

Trial design

Randomised, tal-p: talquetamab in combination with pomalidomide; tal-tec: talquetamab in combination with teclistamab; investigator’s choice comparator: either epd (elotuzumab + pomalidomide + dexamethasone) or pvd (pomalidomide + bortezomib + dexamethasone).-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
Tal-P: Talquetamab in combination with Pomalidomide; Tal-Tec: Talquetamab in combination with Teclistamab; Investigator’s choice comparator: either EPd (Elotuzumab + Pomalidomide + Dexamethasone) or PVd (Pomalidomide + Bortezomib + Dexamethasone).
Target Sample Size
462

Eligibility

Recruits 462 Vulnerable population selected. Participants must be adults (≥18 years). Informed consent is required from the participant; country-specific subject information and informed consent forms (ICFs) are provided (multiple ICF documents listed for different Member States and languages)..

Vulnerable Population
Vulnerable population selected. Participants must be adults (≥18 years). Informed consent is required from the participant; country-specific subject information and informed consent forms (ICFs) are provided (multiple ICF documents listed for different Member States and languages).

Inclusion criteria

  • {"criterion_text":"- Be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent."}
  • {"criterion_text":"- Documented multiple myeloma as defined by the criteria below: a. Multiple myeloma diagnosis according to the IMWG diagnostic criteria. b. Measurable disease at screening as assessed by central laboratory, defined by any of the following: 1. Serum M-protein level ≥0.5 g/dL (central laboratory); or 2. Urine M-protein level ≥200 mg/24 hours (central laboratory); or 3. Light chain multiple myeloma without measurable M protein in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio (central laboratory)"}
  • {"criterion_text":"- Relapsed or refractory disease as defined below: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment. b. Refractory disease is defined as <25% reduction in M-protein or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment."}
  • {"criterion_text":"- Documented evidence of progressive disease or failure to achieve a minimal response to the last line of therapy based on investigator’s determination of response by IMWG criteria on or after their last regimen."}
  • {"criterion_text":"- Have an 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 any study drug or its excipients (refer to the talquetamab IB, teclistamab IB, and appropriate prescribing information)."}
  • {"criterion_text":"- Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF."}
  • {"criterion_text":"- Presence of the following cardiac conditions: a. New York Heart Association Class III or IV congestive heart failure b. Myocardial infarction, unstable angina, or coronary artery bypass graft ≤6 months prior to randomization c. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d. History of severe non-ischemic cardiomyopathy"}
  • {"criterion_text":"- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment."}
  • {"criterion_text":"- Prior or concurrent exposure to any of the following, in the specified time frame prior to randomization: o T cell redirection therapy (for example, antibody therapy or BiTEs) within 3 months o Gene-modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, NK cells) within 3 months o Targeted therapy, epigenetic therapy, mAb therapy, cytotoxic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less o Investigational vaccine other than SARS CoV-2 vaccine approved or authorized for emergency use within 4 weeks o Live, attenuated vaccine within 4 weeks. Non-live and non-replicating vaccines approved or authorized for emergency use (e.g., COVID-19) by local health authorities are allowed. o PI therapy within 14 days o IMiD agent therapy within 14 days o Focal radiation within 7 days"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
462
Recruitment Window Months
39
Consent Approach
Informed consent required from participant (participants must be ≥18). Multiple country-specific ICFs and related patient-facing documents are available (subject information and informed consent forms listed per Member State and in multiple languages).

Geography

Total Number Of Sites
75
Total Number Of Participants
470

Austria

Earliest CTIS Part Ii Submission Date
06-11-2023
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
896
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitätsklinik für Innere Medizin III
Contact Person Name
Thomas Melchardt
Contact Person Email
t.melchardt@salk.at
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
1. Medizinische Abteilung – Zentrum für Onkologie und Hämatologie mit Ambulanz und Palliativstation
Contact Person Name
Thomas Spanberger

Belgium

Earliest CTIS Part Ii Submission Date
02-02-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
808
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
hematolgoy
Contact Person Name
Nicolas Kint
Contact Person Email
nicolas.kint@uzgent.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Hematology
Contact Person Name
Natalie Put
Contact Person Email
natalie.put@zol.be
Site Name
Vitaz
Department Name
Hematology
Contact Person Name
Isabelle Vande Broek
Contact Person Email
isabelle.vandebroek@vitaz.be
Site Name
Grand Hopital De Charleroi
Department Name
Hematology
Contact Person Name
Géraldine Verstraete
Contact Person Email
geraldine.verstraete@ghdc.be

Czechia

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
831
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interni hematologicka klinika (The 4th Department of Internal Medicine – Hematology)
Contact Person Name
Jakub Radocha
Contact Person Email
radochaj@lfhk.cuni.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie FNO a LF OU
Contact Person Name
Roman Hajek
Contact Person Email
roman.hajek@fno.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika (Department of Internal Hematology and Oncology)
Contact Person Name
Ludek Pour
Contact Person Email
pour.ludek@fnbrno.cz
Site Name
University Hospital Olomouc
Department Name
Hematoonkologicka klinika
Contact Person Name
Tomas Pika
Contact Person Email
tomas.pika@fnol.cz

Denmark

Earliest CTIS Part Ii Submission Date
24-01-2024
Latest Decision Or Authorization Date
19-04-2026
Processing Time Days
816
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Odense University Hospital
Department Name
Klovervaenget 10, 12 sal Indgang 112, Haematologisk Forskningsenhed HFE-X
Contact Person Name
Jakub Krejcik
Contact Person Email
Jakub.Krejcik@rsyd.dk
Site Name
Aarhus Universitetshospital
Department Name
Blodsygdomme Klinisk Forskningsenhed
Contact Person Name
Maja Vase
Contact Person Email
majavase@rm.dk

France

Earliest CTIS Part Ii Submission Date
24-01-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
819
Number Of Sites
8
Number Of Participants
90

Sites

Site Name
Hospices Civils De Lyon
Department Name
Hematology Department
Contact Person Name
Lionel KARLIN
Contact Person Email
lionel.karlin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Blood diseases service
Contact Person Name
Salomon MANIER
Contact Person Email
salomon.manier@chu-lille.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Hematology Department
Contact Person Name
Aurore PERROT
Contact Person Email
perrot.aurore@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hematology Department
Contact Person Name
Cyrille HULIN
Contact Person Email
cyrille.hulin@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology and cell therapy
Contact Person Name
Thomas CHALOPIN
Contact Person Email
t.chalopin@chu-tours.fr
Site Name
Institut Paoli-Calmettes
Department Name
Hematology department
Contact Person Name
Jean Marc Schiano De Colella
Contact Person Email
schianojm@ipc.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Immuno-Hematology Service
Contact Person Name
Bertrand ARNULF
Contact Person Email
bertrand.arnulf@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology Department
Contact Person Name
Cyrille TOUZEAU
Contact Person Email
cyrille.touzeau@chu-nantes.fr

Germany

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
825
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Abt. Haematologie/Onkologie
Contact Person Name
Franziska Brunner
Contact Person Email
franziska.brunner@uk-halle.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Comprehensive Cancer Center Augsburg - CCCA
Contact Person Name
Tim Pfeiffer
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Abt. f. Innere Medizin II Haematologie/Onkologie/Rheumatologie
Contact Person Name
Britta Besemer
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Abt. f. Innere Medizin 5; Schwerpunkt fuer Onkologie/ Haematologie/ Rheumatologie
Contact Person Name
Marc-Steffen Raab

Greece

Earliest CTIS Part Ii Submission Date
06-11-2023
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
896
Number Of Sites
3
Number Of Participants
34

Sites

Site Name
251 Air Force General Hospital
Department Name
Hematology Clinic
Contact Person Name
Dimitrios Christoulas
Contact Person Email
christoulasdimitrios@gmail.com
Site Name
Theageneio Cancer Hospital
Department Name
Hematology Oncology Department
Contact Person Name
Eirini Katodritou
Contact Person Email
eirinikatodritou@gmail.com
Site Name
General Hospital Of Athens Alexandra
Department Name
Department of Clinical Therapeutics
Contact Person Name
Meletios Athanasios Dimopoulos
Contact Person Email
mdimop@med.uoa.gr

Hungary

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
714
Number Of Sites
6
Number Of Participants
35

Sites

Site Name
University Of Debrecen
Contact Person Name
Árpád Illés
Contact Person Email
illesarpaddr@gmail.com
Site Name
Semmelweis University
Department Name
Belgyógyászati es Hematológiai Klinika
Contact Person Name
Gergely Varga
Contact Person Email
vargager@gmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Contact Person Name
László Rejtő
Contact Person Email
lrejto@med.unideb.hu
Site Name
University Of Szeged
Department Name
Belgyógyászat
Contact Person Name
Szabolcs Modok
Contact Person Email
moszadokbolcs@gmail.com
Site Name
University Of Pecs
Contact Person Name
Hussain Alizadeh
Contact Person Email
alizadeh.hussain@pte.hu
Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Contact Person Name
Gabor Mikala
Contact Person Email
gmikala@laszlokorhaz.hu

Italy

Earliest CTIS Part Ii Submission Date
06-12-2023
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
867
Number Of Sites
13
Number Of Participants
80

Sites

Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
U.O. Clinica Ematologica
Contact Person Name
Michele Cea
Contact Person Email
michele.cea@unige.i
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Ospedale Borgo Roma - Policlinico G.B. Rossi - UOC di Ematologia e Centro Trapianto di Midollo Osseo
Contact Person Name
Mauro Krampera
Contact Person Email
mauro.krampera@univr.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Ospedale Santa Maria delle Croci
Contact Person Name
Claudia Cellini
Contact Person Email
claudia.cellini@auslromagna.it
Site Name
Ospedale Garibaldi
Department Name
Presidio Ospedaliero Garibaldi-Nesima
Contact Person Name
Ugo Consoli
Contact Person Email
uconsoli@arnasgaribaldi.it
Site Name
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Department Name
S.C.D.U. Ematologia
Contact Person Name
Federico Monaco
Contact Person Email
federico.monaco@ospedale.al.it
Site Name
Azienda Sanitaria Locale Br
Department Name
U.O.C. Ematologia - P.O. "A. Perrino"
Contact Person Name
Giuseppe Mele
Contact Person Email
giuseppemele2007@gmail.com
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
P.O. Santo Spirito-UOC Ematologia-Dipartimento Oncologico Ematologico
Contact Person Name
Mauro Di Ianni
Contact Person Email
mauro.diianni@asl.pe.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
Contact Person Name
Elena Zamagni
Contact Person Email
e.zamagni@unibo.it
Site Name
Azienda Socio Sanitaria Territoriale Ovest Milanese
Department Name
Ospedale di Legnano
Contact Person Name
Alessandro Corso
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UOC Ematologia
Contact Person Name
Niccolò Bolli
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Onco-Ematologia U.O. Ematologia e TMO
Contact Person Name
Valeria Ferla
Contact Person Email
FERLA.VALERIA@hsr.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Ematologia
Contact Person Name
Silvia Mangiacavalli
Contact Person Email
S.Mangiacavalli@smatteo.pv.it
Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
SSD Clinical Trial in Oncoematologia e Mieloma Multiplo
Contact Person Name
Francesca Gay
Contact Person Email
francesca.gay@unito.it

Spain

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
811
Number Of Sites
14
Number Of Participants
65

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Paula Rodriguez Otero
Contact Person Email
paurodriguez@unav.es
Site Name
Hospital Universitario La Paz
Department Name
Hematology
Contact Person Name
Ana López de la Guia
Contact Person Email
lopguia@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Contact Person Name
Enrique Ocio
Contact Person Email
ocioem@unican.es
Site Name
Hospital Universitario De Navarra
Department Name
Hematology
Contact Person Name
Jose María Arguiñano Pérez
Site Name
Hospital Universitario De Burgos
Department Name
Hematology
Contact Person Name
Jorge Labrador Gómez
Site Name
Hospital Universitario Lucus Augusti
Department Name
Hematology
Contact Person Name
Esperanza Lavilla
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Mercedes Gironella Mesa
Contact Person Email
merce.gironella@vallhebron.cat
Site Name
University Hospital Son Espases
Department Name
Hematology
Contact Person Name
Jose María Sanchez Raga
Contact Person Email
josemaria.sanchez@ssib.es
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Contact Person Name
María Victoria Mateos Manteca
Contact Person Email
mvmateos@usal.es
Site Name
Hospital Universitario De Cabuenes
Department Name
Hematology
Contact Person Name
Maria Esther González García
Contact Person Email
esthergongar@yahoo.es
Site Name
Hospital San Pedro De Alcantara
Department Name
Hematology
Contact Person Name
Ignacio Casas Avilés
Contact Person Email
ignacio.casas@salud-juntaex.es
Site Name
Hospital Universitario Donostia
Department Name
Hematology
Contact Person Name
Maialen Sirvent Auzmendi
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Hematology
Contact Person Name
Marta Sonia González Pérez
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Hematology
Contact Person Name
Esther Clavero Sanchez
Contact Person Email
eclaverosa@hotmail.com

Sweden

Earliest CTIS Part Ii Submission Date
24-01-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
819
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Region Vaesterbotten
Department Name
Klinisk Forskningsenhet Qa41 Cancercentrum
Contact Person Name
Antonio Izarra Santamaria
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Hematologimottagningen, Klinisk forskningsmottagning
Contact Person Name
Konstantinos Lemonakis
Site Name
Uppsala University Hospital
Department Name
KFUE Blod- och Tumorsjukdomar, Ing 100, 1 tr
Contact Person Name
Kristina Carlson
Contact Person Email
kristina.carlson@akademiska.se

Netherlands

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
818
Number Of Sites
6
Number Of Participants
23

Sites

Site Name
Catharina Ziekenhuis Stichting
Department Name
Catherina Cancer Institute
Contact Person Name
Marten Nijziel
Site Name
Flevoziekenhuis Stichting
Department Name
Hematology
Contact Person Name
Koen de Heer
Contact Person Email
kdeheer@flevoziekenhuis.nl
Site Name
St. Antonius Ziekenhuis
Department Name
Hematology
Contact Person Name
Inger Nijhof
Contact Person Email
i.nijhof@antoniusziekenhuis.nl
Site Name
Isala Klinieken Stichting
Department Name
Hematology
Contact Person Name
Paul Geerts
Contact Person Email
p.a.f.geerts@isala.nl
Site Name
Haga Hospital
Department Name
Hematology
Contact Person Name
Paula Ypma
Contact Person Email
p.ypma@hagaziekenhuis.nl
Site Name
St. Antonius Ziekenhuis (duplicate listed in records?)
Department Name
Hematology

Poland

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
816
Number Of Sites
6
Number Of Participants
50

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych
Contact Person Name
Tomasz Wróbel
Contact Person Email
tomasz_wrobel@wp.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej
Contact Person Name
Jacek Krzanowski
Contact Person Email
jacek.krzanowski@gmail.com
Site Name
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Department Name
Oddział Hematologii
Contact Person Name
Piotr Centkowski
Contact Person Email
pcentek@wp.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
Department Name
Klinika Hematologii z Oddziałem Transplantacji Szpiku
Contact Person Name
Bogusław Machaliński
Contact Person Email
machalin@pum.edu.pl
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Hematologii i Transplantacji Szpiku
Contact Person Name
Paweł Steckiewicz
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
Oddzial Hematologii i Transplantacji Szpiku z Bankiem Tkanek i Komorek
Contact Person Name
Wojciech Legieć
Contact Person Email
wlegiec@cozl.pl

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
PK office; duties codes: 15, 6 (as listed)
Name
Icon Clinical Research Limited
Responsibilities
COA translations and linguistic validation (duty code 15)
Name
IQVIA Laboratories LLC
Responsibilities
Laboratory services (duty code 4)
Name
Labcorp Central Laboratory Services LP
Responsibilities
Laboratory services (duty code 4)

Third parties

  • {"country":"United Kingdom","full_name":"The Binding Site Group Limited","duties_or_roles":"[{\"id\":951142,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"[{\"id\":951138,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"[{\"id\":951140,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"id\":951139,\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"[{\"id\":951143,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"[{\"id\":951145,\"code\":\"15\",\"value\":\"PK office\"},{\"id\":951146,\"code\":\"6\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"IQVIA Laboratories LLC","duties_or_roles":"[{\"id\":951133,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"[{\"id\":951147,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"[{\"id\":951136,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"[{\"id\":951148,\"code\":\"15\",\"value\":\"COA translations and linguistic validation\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Qd Solutions Inc.","duties_or_roles":"[{\"id\":951141,\"code\":\"15\",\"value\":\"Patient recruitment and retention materials and site support materials\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"[{\"id\":951134,\"code\":\"15\",\"value\":\"eCOA provider\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"[{\"id\":951144,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"Acolad Belgium","duties_or_roles":"[{\"id\":951135,\"code\":\"15\",\"value\":\"Translation services\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"[{\"id\":951137,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-64407564
Active Substance
TALQUETAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
1
Orphan Designation
Yes
Maximum Dose
800 µg/Kg (maxDailyDoseAmount reported)
Investigational Product Name
teclistamab
Active Substance
TECLISTAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
1
Maximum Dose
3 mg/Kg (maxDailyDoseAmount reported)
Investigational Product Name
Pomalidomide / Imnovid (multiple presentations)
Active Substance
POMALIDOMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
1/2 (various products have prodAuthStatus 1 or 2)
Orphan Designation
True (Imnovid presentations have orphan designation EU/3/09/672)
Maximum Dose
4 mg (maxDailyDoseAmount reported)
Investigational Product Name
Empliciti (Elotuzumab) 300/400 mg
Active Substance
ELOTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
20 mg (maxDailyDoseAmount reported)
Investigational Product Name
VELCADE (Bortezomib)
Active Substance
BORTEZOMIB
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
2
Maximum Dose
20 mg (maxDailyDoseAmount reported)
Investigational Product Name
Dexamethasone (various tablet presentations)
Active Substance
DEXAMETHASONE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Maximum Dose
40 mg (maxDailyDoseAmount reported)
Investigational Product Name
Privigen 100 mg/ml solution for infusion
Active Substance
HUMAN NORMAL IMMUNOGLOBULIN
Modality
Other antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
0 mg/kg reported as maxDailyDoseAmount 0 (per product record)
Combination Treatment
Yes

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