Clinical trial • Phase III • Oncology

ISATUXIMAB for Multiple myeloma | Plasma cell myeloma

Phase III trial of ISATUXIMAB for Multiple myeloma | Plasma cell myeloma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Multiple myeloma | Plasma cell myeloma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
13-08-2024
First CTIS Authorization Date
19-09-2024

Trial design

Randomised, open-label, arm a: isatuximab (isatuximab, intravenous infusion, dose unit mg/kg, product record lists maxdailydoseamount 10 mg/kg) in combination with bortezomib (velcade, subcutaneous/solution for infusion), lenalidomide (lenalidomide oral capsules, product records list maxdailydoseamount up to 25 mg) and dexamethasone (oral or iv formulations, product records list maxdailydoseamount 20 mg). arm b (comparator): bortezomib + lenalidomide + dexamethasone. (doses/schedules not fully specified in the ctis metadata beyond product maximum dose values.)-controlled, crossover Phase III trial across 47 sites in Sweden, Portugal, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Isatuximab (isatuximab, intravenous infusion, dose unit mg/kg, product record lists maxDailyDoseAmount 10 mg/kg) in combination with Bortezomib (VELCADE, subcutaneous/solution for infusion), Lenalidomide (lenalidomide oral capsules, product records list maxDailyDoseAmount up to 25 mg) and Dexamethasone (oral or IV formulations, product records list maxDailyDoseAmount 20 mg). Arm B (comparator): Bortezomib + Lenalidomide + Dexamethasone. (Doses/schedules not fully specified in the CTIS metadata beyond product maximum dose values.)
Crossover
Yes
Target Sample Size
209

Eligibility

Recruits 209 Vulnerable population selected in the trial record. Written informed consent is required. Multiple country-specific subject information and informed consent forms are provided (including partner/pregnancy forms and some child/partner templates listed for specific countries in the document list)..

Pregnancy Exclusion
-Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
Vulnerable Population
Vulnerable population selected in the trial record. Written informed consent is required. Multiple country-specific subject information and informed consent forms are provided (including partner/pregnancy forms and some child/partner templates listed for specific countries in the document list).

Inclusion criteria

  • {"criterion_text":"-Multiple myeloma (International Myeloma Working Group [IMWG] criteria)."}
  • {"criterion_text":"-Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or participants < 65 years with comorbidities impacting possibility of transplant."}
  • {"criterion_text":"-Evidence of measurable disease."}
  • {"criterion_text":"-Written informed consent"}

Exclusion criteria

  • {"criterion_text":"-Age <18 years."}
  • {"criterion_text":"-Prior treatment for multiple myeloma."}
  • {"criterion_text":"-Any other prior or ongoing disease/health conditions incompatible with the study objectives."}
  • {"criterion_text":"-Organ function values not met."}
  • {"criterion_text":"-Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) > 2."}
  • {"criterion_text":"-Hypersensitivity to the study medications."}
  • {"criterion_text":"-Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods."}
  • {"criterion_text":"-Male participants who disagree to follow the study contraceptive counseling."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Progression free survival (PFS)","definition_or_measurement_approach":"To demonstrate prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide and dexamethasone in participants with newly diagnosed multiple myeloma not eligible for transplant."}

Secondary endpoints

  • {"endpoint_text":"-Complete response (CR)","definition_or_measurement_approach":"As defined by the International Myeloma Working Group (IMWG) criteria."}
  • {"endpoint_text":"-Minimal residual disease (MRD) negativity rate for participants with CR","definition_or_measurement_approach":"MRD negativity rate assessed in participants achieving CR (as specified in trial objectives)."}
  • {"endpoint_text":"-Very good partial response (VGPR) or better rate","definition_or_measurement_approach":"Response rates assessed using IMWG criteria (VGPR or better)."}
  • {"endpoint_text":"-Overall survival (OS)","definition_or_measurement_approach":"All-cause survival measured from randomization to death."}
  • {"endpoint_text":"-Overall response rate (ORR)","definition_or_measurement_approach":"Assessed per IMWG criteria."}
  • {"endpoint_text":"-Time to progression (TTP)","definition_or_measurement_approach":"Time from randomization to documented progression."}
  • {"endpoint_text":"-Duration of response (DOR)","definition_or_measurement_approach":"Time from first documented response until progression."}
  • {"endpoint_text":"-Time to first response (TT1R)","definition_or_measurement_approach":"Time from randomization to first documented response."}
  • {"endpoint_text":"-Time to best response (TTBR)","definition_or_measurement_approach":"Time from randomization to best recorded response."}
  • {"endpoint_text":"-PFS on next line of therapy (PFS2)","definition_or_measurement_approach":"Progression-free survival measured on the next line of therapy (PFS2)."}
  • {"endpoint_text":"-PFS in MRD negative participants","definition_or_measurement_approach":"PFS evaluated in the subgroup of participants who are MRD negative."}
  • {"endpoint_text":"-Sustained MRD negativity ≥12 months rate","definition_or_measurement_approach":"Rate of participants with MRD negativity sustained for ≥12 months."}
  • {"endpoint_text":"-Adverse Events","definition_or_measurement_approach":"Safety assessed by recording adverse events per standard reporting."}
  • {"endpoint_text":"-Assessment of PK parameter: Ctrough","definition_or_measurement_approach":"Pharmacokinetic assessment of trough concentration (Ctrough) of isatuximab (IVRd arm only)."}
  • {"endpoint_text":"-Immunogenicity","definition_or_measurement_approach":"Assessment of anti-drug antibodies/immunogenicity in participants receiving isatuximab (IVRd and crossover arms)."}
  • {"endpoint_text":"-Participants reported outcome (PRO): QLQ-C30","definition_or_measurement_approach":"Health-related quality of life assessed using the QLQ-C30 questionnaire."}
  • {"endpoint_text":"-PRO: QLQ-MY20","definition_or_measurement_approach":"Disease-specific quality of life assessed using the QLQ-MY20 instrument."}
  • {"endpoint_text":"-PRO: EQ-5D-5L","definition_or_measurement_approach":"Health state utility and status assessed using the EQ-5D-5L questionnaire."}

Recruitment

Planned Sample Size
209
Recruitment Window Months
114
Consent Approach
Written informed consent is required. Multiple country-specific subject information and informed consent forms are provided (documents list includes ICFs and partner/pregnancy forms and some child/partner templates). ICFs are provided in multiple country/language versions (examples in the document list include Swedish, Portuguese, Spanish, Greek, French, Italian, Lithuanian, Polish, German, Danish, Czech and others).

Geography

Total Number Of Sites
47
Total Number Of Participants
308

Sweden

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
20-09-2024
Processing Time Days
21
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Karolinska University Hospital
Department Name
Haematology Centre, R 51
Principal Investigator Name
Johan Lund
Principal Investigator Email
johan.l.lund@regionstockholm.se
Contact Person Name
Johan Lund
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Hematologmottagningen
Principal Investigator Name
Johan Theander
Principal Investigator Email
johan.theander@skane.se
Contact Person Name
Johan Theander
Contact Person Email
johan.theander@skane.se

Portugal

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
19-09-2024
Processing Time Days
20
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Principal Investigator Name
Adriana Roque
Principal Investigator Email
adriroque05@hotmail.com
Contact Person Name
Adriana Roque
Contact Person Email
adriroque05@hotmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Principal Investigator Name
Herlander Marques
Principal Investigator Email
herlandermarques@hotmail.com
Contact Person Name
Herlander Marques
Contact Person Email
herlandermarques@hotmail.com
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Principal Investigator Name
Angelo Martins
Principal Investigator Email
angelo.telma@gmail.com
Contact Person Name
Angelo Martins
Contact Person Email
angelo.telma@gmail.com
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Departamento de Hematologia
Principal Investigator Name
Fernando Leal da Costa
Principal Investigator Email
flcosta@ipolisboa.min-saude.pt
Contact Person Name
Fernando Leal da Costa
Contact Person Email
flcosta@ipolisboa.min-saude.pt

Italy

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
24-09-2024
Processing Time Days
25
Number Of Sites
4
Number Of Participants
19

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I( #1)
Principal Investigator Name
Massimo Offidani
Principal Investigator Email
massimo.offidani@ospedaliriuniti.marche.it
Contact Person Name
Massimo Offidani
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
A.S.S.T Spedali Civili di Brescia( #1)
Principal Investigator Name
Alessandra Tucci
Principal Investigator Email
alessandra.tucci@asst-spedalicivili.it
Contact Person Name
Alessandra Tucci
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Presidio Molinette
Principal Investigator Name
Giulia Benevolo
Principal Investigator Email
gbenevolo@cittadellasalute.to.it
Contact Person Name
Giulia Benevolo
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dip di Med.Specialistica, Diagnostica e Sperimentale-Unita Operativa 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

Germany

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
20-09-2024
Processing Time Days
21
Number Of Sites
4
Number Of Participants
21

Sites

Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Hamatologie/Onkiologie
Principal Investigator Name
Julia Pross
Principal Investigator Email
Julia.Pross@heliosgesundheit.de
Contact Person Name
Julia Pross
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Medizinische Klinik II Abteilung Hämatologie und Onkologie
Principal Investigator Name
Ivana Metzler
Principal Investigator Email
metzler@med.uni-frankfurt.de
Contact Person Name
Ivana Metzler
Contact Person Email
metzler@med.uni-frankfurt.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Hamatologie, Onkologie etc.
Principal Investigator Name
Britta Besemer
Principal Investigator Email
britta.besemer@med.uni-tuebingen.de
Contact Person Name
Britta Besemer
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Hämatologie, Onkologie und Rheumatologie
Principal Investigator Name
Hartmut Goldschmidt
Principal Investigator Email
hartmut.goldschmidt@med.uni-heidelberg.de
Contact Person Name
Hartmut Goldschmidt

Spain

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
19-09-2024
Processing Time Days
20
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
Hospital General Universitario Morales Meseguer
Department Name
Servicio de Hematología y Oncología Médica
Principal Investigator Name
Felipe de Arriba de la Fuente
Principal Investigator Email
farriba@um.es
Contact Person Name
Felipe de Arriba de la Fuente
Contact Person Email
farriba@um.es
Site Name
Vall D Hebron Institute Of Oncology
Department Name
Servei d'Hematologia
Principal Investigator Name
Mercedes Gironella Mesa
Principal Investigator Email
mgironel@gmail.com
Contact Person Name
Mercedes Gironella Mesa
Contact Person Email
mgironel@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servei d'Hematologia
Principal Investigator Name
Jordi Lopez
Principal Investigator Email
jlopezpar@santpau.cat
Contact Person Name
Jordi Lopez
Contact Person Email
jlopezpar@santpau.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Hematología y Hemoterapia
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

Lithuania

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
03-10-2024
Processing Time Days
34
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Hematology, Oncology and Transfusion Medicine Center
Principal Investigator Name
Valdas Peceliunas
Principal Investigator Email
valdas.peceliunas@santa.lt
Contact Person Name
Valdas Peceliunas
Contact Person Email
valdas.peceliunas@santa.lt
Site Name
Klaipedos universiteto ligonine VšĮ
Department Name
Klaipeda Seamen's hospital( #1)
Principal Investigator Name
Mindaugas Jurgutis
Principal Investigator Email
mindaugas.jurgutis@kulig.lt
Contact Person Name
Mindaugas Jurgutis
Contact Person Email
mindaugas.jurgutis@kulig.lt

France

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
20-09-2024
Processing Time Days
21
Number Of Sites
12
Number Of Participants
89

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Departement hématologie, maladies du sang
Principal Investigator Name
Thierry Facon
Principal Investigator Email
thierry.facon@chru-lille.fr
Contact Person Name
Thierry Facon
Contact Person Email
thierry.facon@chru-lille.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Service onco hématologie
Principal Investigator Name
Komivi AGBETSIVI
Principal Investigator Email
komivi.agbetsivi@chd-vendee.fr
Contact Person Name
Komivi AGBETSIVI
Contact Person Email
komivi.agbetsivi@chd-vendee.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Service Hématologie
Principal Investigator Name
Julie GAY
Principal Investigator Email
jgay@ch-cotebasque.fr
Contact Person Name
Julie GAY
Contact Person Email
jgay@ch-cotebasque.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hématologie et Therapie cellulaire
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
Centre Hospitalier De La Cote De Nacre (Caen)
Department Name
Service Hématologie Clinique
Principal Investigator Name
Margaret Macro
Principal Investigator Email
macro-m@chu-caen.fr
Contact Person Name
Margaret Macro
Contact Person Email
macro-m@chu-caen.fr
Site Name
Hopital Saint Antoine
Department Name
Hématologie clinique et Therapie cellulaire
Principal Investigator Name
Mohamad MOHTY
Principal Investigator Email
mohamad.mohty@inserm.fr
Contact Person Name
Mohamad MOHTY
Contact Person Email
mohamad.mohty@inserm.fr
Site Name
CHRU De Nancy
Department Name
Service Hématologie
Principal Investigator Name
Pierre Feugier
Principal Investigator Email
p.feugier@chru-nancy.fr
Contact Person Name
Pierre Feugier
Contact Person Email
p.feugier@chru-nancy.fr
Site Name
Hospices Civils De Lyon
Department Name
Service Hématologie Clinique
Principal Investigator Name
Lionel Karlin
Principal Investigator Email
lionel.karlin@chu-lyon.fr
Contact Person Name
Lionel Karlin
Contact Person Email
lionel.karlin@chu-lyon.fr
Site Name
Oncopole Claudius Regaud
Department Name
Service hématologie-médecine interne
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
Hospital Hotel Dieu (Nantes)
Department Name
Departement hématologie
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 Dijon
Department Name
Service d'Hématologie clinique
Principal Investigator Name
JEAN NOEL BASTIE
Principal Investigator Email
jean-noel.bastie@chu-dijon.fr
Contact Person Name
JEAN NOEL BASTIE
Contact Person Email
jean-noel.bastie@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hématologie clinique et Therapie cellulaire
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

Greece

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
04-12-2024
Processing Time Days
28
Number Of Sites
3
Number Of Participants
34

Sites

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
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department - BMT Unit
Principal Investigator Name
MARIA PAPATHANASIOU
Principal Investigator Email
ppthsmr@gmail.com
Contact Person Name
MARIA PAPATHANASIOU
Contact Person Email
ppthsmr@gmail.com
Site Name
Evangelismos S.A.
Department Name
Department of Hematology and Bone Marrow Transplantation Unit
Principal Investigator Name
SOSANA DELIMPASI
Principal Investigator Email
sodeli@yahoo.com
Contact Person Name
SOSANA DELIMPASI
Contact Person Email
sodeli@yahoo.com

Poland

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
31
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klin.Nowotworow Ukl. Chlonnego
Principal Investigator Name
JOANNA Romejko-Jarosinska
Principal Investigator Email
joanna.romejko-jarosinska@pib-nio.pl
Contact Person Name
JOANNA Romejko-Jarosinska
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Monika Szarejko
Principal Investigator Email
monasza1@gumed.edu.pl
Contact Person Name
Monika Szarejko
Contact Person Email
monasza1@gumed.edu.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Odział Hematologii Ogólnej i Chorób Wewnętrznych
Principal Investigator Name
Tadeusz ROBAK
Principal Investigator Email
robaktad@csk.umed.lodz.pl
Contact Person Name
Tadeusz ROBAK
Contact Person Email
robaktad@csk.umed.lodz.pl

Czechia

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
20-09-2024
Processing Time Days
21
Number Of Sites
6
Number Of Participants
55

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
Vladimir Maisnar
Principal Investigator Email
vladimir.maisnar@fnhk.cz
Contact Person Name
Vladimir Maisnar
Contact Person Email
vladimir.maisnar@fnhk.cz
Site Name
University Hospital Olomouc
Department Name
Hemato-onkologicka klinika
Principal Investigator Name
Jiri Minarik
Principal Investigator Email
Jiri.Minarik2@fnol.cz
Contact Person Name
Jiri Minarik
Contact Person Email
Jiri.Minarik2@fnol.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
Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika
Principal Investigator Name
Martin Stork
Principal Investigator Email
stork.martin@fnbrno.cz
Contact Person Name
Martin Stork
Contact Person Email
stork.martin@fnbrno.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
Hematologicko-onkologicke oddeleni
Principal Investigator Name
Alexandra Jungova
Principal Investigator Email
jungovaa@fnplzen.cz
Contact Person Name
Alexandra Jungova
Contact Person Email
jungovaa@fnplzen.cz

Denmark

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
20-09-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Aalborg University Hospital
Department Name
Department of Haematology
Principal Investigator Name
Elena Manuela Teodorescu
Principal Investigator Email
emt@rn.dk
Contact Person Name
Elena Manuela Teodorescu
Contact Person Email
emt@rn.dk
Site Name
Odense University Hospital
Department Name
Department of Haematology X
Principal Investigator Name
Charlotte Toftmann Hansen
Principal Investigator Email
Charlotte.Toftmann.Hansen2@rsyd.dk
Contact Person Name
Charlotte Toftmann Hansen
Site Name
Aarhus Universitetshospital
Department Name
Hematologisk afd.
Principal Investigator Name
Anja Klostergaard
Principal Investigator Email
Anja.Klostergaard@rm.dk
Contact Person Name
Anja Klostergaard
Contact Person Email
Anja.Klostergaard@rm.dk

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Teckro Limited
Responsibilities
study service outsourced
Name
ESMS Global Limited
Responsibilities
Centralized 24-Hour Emergency System: eSMS
Name
Bioclinica Inc.
Responsibilities
Central Medical Reading or Imaging Reading
Name
Euraxi Pharma
Responsibilities
Other study service outsourced (for G&L SPL)

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Portugal","full_name":"Evidenze Portugal Unipessoal Lda.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"study service outsourced","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"Signant Health Oy","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Tamro AB","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Pharmalink Sp. z o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Czechia","full_name":"Zentiva k.s.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Euraxi Pharma","duties_or_roles":"Other study service outsourced (for G&L SPL)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Medical Reading or Imaging Reading","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Portugal","full_name":"Logiters Logistica Portugal S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Isatuximab
Active Substance
ISATUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
prodAuthStatus 1 (as recorded)
Maximum Dose
10 mg/kg
Investigational Product Name
VELCADE 3.5 mg powder for solution for injection (bortezomib)
Active Substance
BORTEZOMIB
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
prodAuthStatus 2 (authorized marketing authorisation present)
Maximum Dose
1.3 mg/m3 (as recorded in product metadata)
Investigational Product Name
Lenalidomide (Revlimid / Zelvina formulations listed)
Active Substance
LENALIDOMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 2 (authorized marketing authorisation present for listed products)
Dose Levels
multiple capsule strengths available (5 mg, 10 mg, 15 mg, 20 mg, 25 mg listed)
Maximum Dose
25 mg (maxDailyDoseAmount as listed in product entries)
Investigational Product Name
Dexamethasone (various formulations listed)
Active Substance
DEXAMETHASONE / DEXAMETHASONE SODIUM PHOSPHATE
Modality
Small molecule
Routes Of Administration
ORAL / INTRAVENOUS USE
Route
ORAL / INTRAVENOUS USE
Authorisation Status
prodAuthStatus 2 (authorized marketing authorisation present for listed products)
Maximum Dose
20 mg (maxDailyDoseAmount as listed in product entries)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.