Clinical trial • Phase III • Oncology

Mezigdomide for Relapsed or refractory multiple myeloma

Phase III trial of Mezigdomide for Relapsed or refractory multiple myeloma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed or refractory multiple myeloma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
25-04-2024
First CTIS Authorization Date
18-06-2024

Trial design

Randomised, open-label, mezigdomide (cc-92480) + bortezomib + dexamethasone versus pomalidomide + bortezomib + dexamethasone; dosing and schedule not specified in available ctis data.-controlled, adaptive Phase III trial in Belgium, Czechia, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Mezigdomide (CC-92480) + Bortezomib + Dexamethasone versus Pomalidomide + Bortezomib + Dexamethasone; dosing and schedule not specified in available CTIS data.
Adaptive
True, two-stage design: Stage 1 is a dose-finding/determination stage to identify the recommended mezigdomide dose to continue into Stage 2 (Stage 2 is the randomized comparison).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
576

Eligibility

Recruits 576 Vulnerable population flag selected. Study materials include pregnancy-specific informed consent forms and partner consent forms (e.g. documents titled 'Pregnant Patient IC' and 'Pregnant Partner IC' in multiple languages). Informed consent is obtained using subject information sheets and ICF documents; specific pregnancy-related consent/partner consent forms are provided. No explicit assent process for minors is stated in the available material..

Vulnerable Population
Vulnerable population flag selected. Study materials include pregnancy-specific informed consent forms and partner consent forms (e.g. documents titled 'Pregnant Patient IC' and 'Pregnant Partner IC' in multiple languages). Informed consent is obtained using subject information sheets and ICF documents; specific pregnancy-related consent/partner consent forms are provided. No explicit assent process for minors is stated in the available material.

Inclusion criteria

  • {"criterion_text":"- Subject has documented diagnosis of MM and measurable disease, defined as: —M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or —For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio\n- Subject has received 1 to 3 prior anti-myeloma lines of therapy\n- Subject must have received prior treatment with a lenalidomide containing regimen. For country-specific requirements, see APPENDIX I\n- Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy\n- Subject must have documented disease progression during or after their last antimyeloma regimen\n- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2."}

Exclusion criteria

  • {"criterion_text":"- Subject has had prior treatment with mezigdomide or pomalidomide\n- Subject has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below: a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded.\n- For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression free Survival (PFS)","definition_or_measurement_approach":"Progression-free survival (PFS): comparison of PFS between MeziVd and PVd; time from randomisation to disease progression or death (progression-free survival)."}

Secondary endpoints

  • {"endpoint_text":"- Recommended mezigdomide dose\n- Pharmacokinetics\n- Overall Survival (OS)\n- Overall Response Rate (OR)\n- Complete Response Rate (CR) or better\n- Very Good Partial Response Rate (VGPR) or better\n- Time to Response (TTR)\n- Duration of Response (DOR)\n- Time to Progression (TTP)\n- Time to Next Treatment (TTNT)\n- Progression-free survival 2 (PFS-2)\n- Minimal residual disease (MRD) negativity\n- Safety\n- Health Related Quality of Life (HRQoL) Evaluation","definition_or_measurement_approach":"Definitions/measurement approaches where available: Recommended mezigdomide dose determined in Stage 1 (dose-finding). Pharmacokinetics: plasma concentrations of mezigdomide measured. OS: time from randomisation to death. Response endpoints (OR, CR, VGPR, TTR, DOR, TTP, TTNT): standard response and time-to-event measures per protocol. PFS-2: time from randomisation to disease progression with the next anti-myeloma therapy or death, whichever occurs first. MRD negativity: assessed per protocol (MRD assessment vendor Hematogenix listed). Safety: adverse events monitoring. HRQoL: measured using EORTC QLQ-C30 and EORTC QLQ-MY20."}

Recruitment

Planned Sample Size
576
Recruitment Window Months
142
Consent Approach
Informed consent is obtained using subject information sheets (SIS) and informed consent forms (ICF). Multiple language versions and country-adapted ICFs are provided (examples: English, French, Dutch, German, Spanish, Portuguese, Polish, Greek, Russian noted among available documents). There are specific pregnancy-related consent forms (pregnant participant and pregnant partner forms). The available documentation does not specify assent procedures for minors.

Methods

  • Site-based recruitment via participating hospitals and oncology/hematology clinics; country-specific recruitment arrangements (K1 documents) and patient-facing brochures/overview sheets (K2) are provided for multiple countries (examples: BE, DE, AT, IE, CZ, FR, IT, ES, PL, PT, RO, FI, GR). Recruitment materials are available in multiple languages and include patient brochures, study overview sheets and local K1 recruitment documents.

Geography

Total Number Of Sites
66
Total Number Of Participants
325

Belgium

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
664
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
Hematology
Principal Investigator Name
Natalie Put
Principal Investigator Email
natalie.put@zol.be
Contact Person Name
Natalie Put
Contact Person Email
natalie.put@zol.be
Site Name
Vitaz
Department Name
Medical Oncology/Hematology
Principal Investigator Name
Isabelle Vande Broek
Principal Investigator Email
Isabelle.VandeBroek@vitaz.be
Contact Person Name
Isabelle Vande Broek
Contact Person Email
Isabelle.VandeBroek@vitaz.be
Site Name
Het Ziekenhuisnetwerk Antwerpen
Department Name
Hematology
Principal Investigator Name
Ka Lung Wu
Principal Investigator Email
kalung.wu@zna.be
Contact Person Name
Ka Lung Wu
Contact Person Email
kalung.wu@zna.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Principal Investigator Name
Nicolas Kint
Principal Investigator Email
nicolas.kint@uzgent.be
Contact Person Name
Nicolas Kint
Contact Person Email
nicolas.kint@uzgent.be

Czechia

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
663
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika FN Brno
Principal Investigator Name
Ludek Pour
Principal Investigator Email
pour.ludek@fnbrno.cz
Contact Person Name
Ludek Pour
Contact Person Email
pour.ludek@fnbrno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interni klinika - klinika hematologie 1.LF a VFN
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 Kralovske Vinohrady
Department Name
Hematologicka klinika
Principal Investigator Name
Jan Soukup
Principal Investigator Email
jan.soukup@fnkv.cz
Contact Person Name
Jan Soukup
Contact Person Email
jan.soukup@fnkv.cz

Germany

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
671
Number Of Sites
13
Number Of Participants
35

Sites

Site Name
Praxis Onkologie am Raschplatz Hannover
Department Name
Studienzentrum
Principal Investigator Name
Eyck von der Heyde
Principal Investigator Email
vdheyde@onkologie-am-raschplatz.de
Contact Person Name
Eyck von der Heyde
Site Name
MVZ Nordoberpfalz GmbH
Department Name
Department of Oncology and Hematology at Medical Care Center Nordoberpfalz
Principal Investigator Name
Thomas Schichtl
Principal Investigator Email
thomas.schichtl@mvz-weiden.de
Contact Person Name
Thomas Schichtl
Contact Person Email
thomas.schichtl@mvz-weiden.de
Site Name
Kliniken Suedostbayern AG
Department Name
Department for Hematology, Oncology and Palliative Medicine
Principal Investigator Name
Matthias Egger
Principal Investigator Email
matthias.egger@kliniken-sob.de
Contact Person Name
Matthias Egger
Contact Person Email
matthias.egger@kliniken-sob.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medical Clinic Section for Stem Cell and Immunotherapy
Principal Investigator Name
Natalie Schub
Principal Investigator Email
natalie.schub@uksh.de
Contact Person Name
Natalie Schub
Contact Person Email
natalie.schub@uksh.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
Gemeinschaftspraxis Freiberg-Richter, Jacobasch, Illmer, Wolf Haematologie, Onkologie
Principal Investigator Name
Thomas Illmer
Principal Investigator Email
illmer@onkologie-dresden.net
Contact Person Name
Thomas Illmer
Contact Person Email
illmer@onkologie-dresden.net
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Klinik Altona
Principal Investigator Name
Hans-Jürgen Salwender
Principal Investigator Email
h.salwender@asklepios.com
Contact Person Name
Hans-Jürgen Salwender
Contact Person Email
h.salwender@asklepios.com
Site Name
Marien Hospital Duesseldorf GmbH
Department Name
Klinik für Onkologie, Hämatologie und Palliativmedizin
Principal Investigator Name
Maika Klaiber-Hakimi
Principal Investigator Email
maika.klaiber-hakimi@vkkd-kliniken.de
Contact Person Name
Maika Klaiber-Hakimi
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medical Clinic & Polyclinic Center for Oncology
Principal Investigator Name
Katja Weisel
Principal Investigator Email
k.weisel@uke.de
Contact Person Name
Katja Weisel
Contact Person Email
k.weisel@uke.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Internal Medicine II, Dept. of Oncology, Hematology, Rheumatology, Immunology
Principal Investigator Name
Britta Besemer
Principal Investigator Email
britta.besemer@med.uni-tuebingen.de
Contact Person Name
Britta Besemer
Site Name
Haematologisch Onkologische Schwerpunktpraxis
Department Name
Hematology-oncology specialist practice
Principal Investigator Name
Dominik Pretscher
Principal Investigator Email
d.pretscher@onkopraxis-wuerzburg.de
Contact Person Name
Dominik Pretscher
Site Name
Sozialstiftung Bamberg
Department Name
Sozialstiftung Bamberg, Klinikum am Bruderwald
Principal Investigator Name
Christof Schweizer
Contact Person Name
Christof Schweizer
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Clinic for Hematology, Oncology, Hemostaseology and Stem Cell Transplant (Medical clinic IV)
Principal Investigator Name
Deniz Nogueira-Gezer
Principal Investigator Email
dgezer@ukaachen.de
Contact Person Name
Deniz Nogueira-Gezer
Contact Person Email
dgezer@ukaachen.de
Site Name
Philipps-Universitaet Marburg
Department Name
Center for Internal Medicine; Clinic for Hematology, Oncology and Immunology
Principal Investigator Name
Christoph Mann
Principal Investigator Email
christoph.mann@med.uni-marburg.de
Contact Person Name
Christoph Mann

Austria

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
671
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department Name
Department for Hemato-Oncology
Principal Investigator Name
Thamer Sliwa
Principal Investigator Email
thamer.sliwa@kages.at
Contact Person Name
Thamer Sliwa
Contact Person Email
thamer.sliwa@kages.at
Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
3rd Medical Department
Principal Investigator Name
Michael Fillitz
Principal Investigator Email
michael.fillitz@oegk.at
Contact Person Name
Michael Fillitz
Contact Person Email
michael.fillitz@oegk.at
Site Name
Universitaetsklinikum Krems
Department Name
Clinical Department for Internal Medicine II
Principal Investigator Name
Klaus Podar
Principal Investigator Email
klaus.podar@krems.lknoe.at
Contact Person Name
Klaus Podar
Contact Person Email
klaus.podar@krems.lknoe.at
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
1st Medical Department, Center for Oncology and Hematology
Principal Investigator Name
Thomas Spannberger
Principal Investigator Email
Thomas.spannberger@gesundheitsverbund.at
Contact Person Name
Thomas Spannberger
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Clinical Department for Internal Medicine I
Principal Investigator Name
Petra Pichler
Principal Investigator Email
petra.pichler@stpoelten.lknoe.at
Contact Person Name
Petra Pichler

Finland

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
671
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Kuopio University Hospital
Department Name
Department of Hematology
Principal Investigator Name
Anu Partanen
Principal Investigator Email
anu.partanen@pshyvinvointialue.fi
Contact Person Name
Anu Partanen
Site Name
HUS-Yhtymae
Department Name
Comprehensive cancer center
Principal Investigator Name
Suvi Luoma
Principal Investigator Email
suvi.luoma@hus.fi
Contact Person Name
Suvi Luoma
Contact Person Email
suvi.luoma@hus.fi

Ireland

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
671
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
Cork University Hospital
Department Name
Oncology
Principal Investigator Name
Vitaliy Mykytiv
Principal Investigator Email
uccctg@ucc.ie
Contact Person Name
Vitaliy Mykytiv
Contact Person Email
uccctg@ucc.ie
Site Name
University Hospital Galway
Department Name
Oncology
Principal Investigator Name
Janusz Krawczyk
Principal Investigator Email
XXX@XXXX.ie
Contact Person Name
Janusz Krawczyk
Contact Person Email
XXX@XXXX.ie
Site Name
St James's Hospital
Department Name
Oncology
Principal Investigator Name
Patrick Hayden
Principal Investigator Email
research@stjames.ie
Contact Person Name
Patrick Hayden
Contact Person Email
research@stjames.ie

France

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
671
Number Of Sites
11
Number Of Participants
64

Sites

Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hematology
Principal Investigator Name
Anne Pascale Grandjean
Principal Investigator Email
apgrandjean@chu-clermontferrand.fr
Contact Person Name
Anne Pascale Grandjean
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology
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
Institut De Cancerologie Strasbourg Europe
Department Name
Hematology
Principal Investigator Name
Cecile Sonntag
Principal Investigator Email
c.sonntag@icans.eu
Contact Person Name
Cecile Sonntag
Contact Person Email
c.sonntag@icans.eu
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hematology
Principal Investigator Name
Cecile Sonntag
Principal Investigator Email
c.sonnetag@icans.eu
Contact Person Name
Cecile Sonntag
Contact Person Email
c.sonnetag@icans.eu
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology
Principal Investigator Name
Thomas Chalopin
Principal Investigator Email
t.chalopin@chu-tours.fr
Contact Person Name
Thomas Chalopin
Contact Person Email
t.chalopin@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology
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
Centre Leon Berard
Department Name
Hematology
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
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hematology
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
Centre Hospitalier Universitaire De Nimes
Department Name
Hematology
Principal Investigator Name
Agathe Rascalou Waultier
Principal Investigator Email
agathe.waultier.rascalou@chu-nimes.fr
Contact Person Name
Agathe Rascalou Waultier
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hematology
Principal Investigator Name
Salomon Manier
Principal Investigator Email
salomon.manier@chru-lille.fr
Contact Person Name
Salomon Manier
Contact Person Email
salomon.manier@chru-lille.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hematology
Principal Investigator Name
Murielle Roussel
Principal Investigator Email
murielle.roussel@chu-limoges.fr
Contact Person Name
Murielle Roussel

Italy

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
672
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Ematologia
Principal Investigator Name
Silvia Mangiacavalli
Principal Investigator Email
s.mangiacavalli@smatteo.pv.it
Contact Person Name
Silvia Mangiacavalli
Contact Person Email
s.mangiacavalli@smatteo.pv.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
UOC Ematologia
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
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Istituto di Ematologia "L e A Seragnoli"
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 Ospedaliero-Universitaria Sant Andre
Department Name
UOC Ematologia
Principal Investigator Name
Giacinto La Verde
Principal Investigator Email
giacintolaverde@gmail.com
Contact Person Name
Giacinto La Verde
Contact Person Email
giacintolaverde@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Onco-Hematology
Principal Investigator Name
Davide Nappi
Principal Investigator Email
davide.nappi@irst.emr.it
Contact Person Name
Davide Nappi
Contact Person Email
davide.nappi@irst.emr.it

Spain

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
672
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Hospital General Universitario Morales Meseguer
Department Name
Hematology and Medical Oncology
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
University Hospital Son Espases
Department Name
Hematology
Principal Investigator Name
Antonia Sampol Mayol
Principal Investigator Email
antonia.sampolm@ssib.es
Contact Person Name
Antonia Sampol Mayol
Contact Person Email
antonia.sampolm@ssib.es
Site Name
Hospital Universitario De Leon
Department Name
Hematology
Principal Investigator Name
FERNANDO ESCALANTE
Principal Investigator Email
xxxxxxx@xxxxx.es
Contact Person Name
FERNANDO ESCALANTE
Contact Person Email
xxxxxxx@xxxxx.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Joaquin Martinez
Principal Investigator Email
j.martinez@salud.madrid.org
Contact Person Name
Joaquin Martinez
Contact Person Email
j.martinez@salud.madrid.org
Site Name
Hospital Costa Del Sol
Department Name
Hematology
Principal Investigator Name
Maria Casanova
Principal Investigator Email
xxxxxxx@xxxx.com
Contact Person Name
Maria Casanova
Contact Person Email
xxxxxxx@xxxx.com
Site Name
Hospital San Pedro De Alcantara
Department Name
Hematology
Principal Investigator Name
Juan Miguel Bergua Burgués
Principal Investigator Email
xxxxxxx@xxx.xx
Contact Person Name
Juan Miguel Bergua Burgués
Contact Person Email
xxxxxxx@xxx.xx
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Principal Investigator Name
Laura Rosinol
Principal Investigator Email
lrosinol@clinic.cat
Contact Person Name
Laura Rosinol
Contact Person Email
lrosinol@clinic.cat

Poland

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
673
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Pratia Hematologia Sp. z o.o.
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
anna.jakubiec@pratia.com
Contact Person Name
Sebastian Grosicki
Contact Person Email
anna.jakubiec@pratia.com
Site Name
MICS Centrum Medyczne Torun
Principal Investigator Name
Dominik Chraniuk
Principal Investigator Email
d.chraniuk@naszlekarz.pl
Contact Person Name
Dominik Chraniuk
Contact Person Email
d.chraniuk@naszlekarz.pl
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Hematologii
Principal Investigator Name
Agnieszka Kolkowska-Lesniak
Principal Investigator Email
agnieszka.kolkowska@poczta.fm
Contact Person Name
Agnieszka Kolkowska-Lesniak
Contact Person Email
agnieszka.kolkowska@poczta.fm
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddzial Hematologii i Translantacji
Principal Investigator Name
Wojciech Homenda
Principal Investigator Email
wojhom@sl.home.pl
Contact Person Name
Wojciech Homenda
Contact Person Email
wojhom@sl.home.pl

Portugal

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
673
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Onco-Hematologia
Principal Investigator Name
Angelo Martins
Principal Investigator Email
angelo.martins@ipoporto.min-saude.pt
Contact Person Name
Angelo Martins
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Unidade de Investigação Clínica
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
Cristina João
Principal Investigator Email
cristina.joao@fundacaochampalimaud.pt
Contact Person Name
Cristina João

Romania

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
674
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Hematology
Principal Investigator Name
Catalin Danaila
Principal Investigator Email
programari@iroiasi.ro
Contact Person Name
Catalin Danaila
Contact Person Email
programari@iroiasi.ro
Site Name
Institutul Clinic Fundeni
Department Name
Hematology
Principal Investigator Name
Sorina Nicoleta Badalita
Principal Investigator Email
hematologie1@icfundeni.ro
Contact Person Name
Sorina Nicoleta Badalita
Contact Person Email
hematologie1@icfundeni.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Hematology
Principal Investigator Name
Ciprian Tomuleasa
Principal Investigator Email
office@iocn.ro
Contact Person Name
Ciprian Tomuleasa
Contact Person Email
office@iocn.ro

Greece

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
615
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Evaggelismos Hospital
Department Name
Hematology and Lymphoma/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
Site Name
Alexandra Hospital
Department Name
Plasma Cell Dyscrasias Unit, 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
Department of Haematology- Haematopoietic Cell Transplantation Centre
Principal Investigator Name
Ioanna Sakellari
Principal Investigator Email
bmt@gpapanikolaou.gr
Contact Person Name
Ioanna Sakellari
Contact Person Email
bmt@gpapanikolaou.gr

Sponsor

Primary sponsor

Full Name
Celgene Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Endpoint Clinical Inc.
Responsibilities
IVRS – treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re)Supplies Assignment
Name
Icon (Lr) Limited
Responsibilities
Local Lab Management Sevice (iRIS)
Name
Syneos Health Inc.
Responsibilities
responsibilities listed as code '1' in CTIS record (operational/CRO services)
Name
Medidata Solutions Inc.
Responsibilities
responsibilities listed as code '6' in CTIS record (electronic data capture/vendor)

Third parties

  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"PK Testing & Reporting","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"BMB IHC Testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS – treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re)Supplies Assignment","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Frontage Laboratories (Shanghai) Co. Ltd.","duties_or_roles":"PK testing and reporting","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"PRO/COA","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage for PK and BMs","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Tumor blocks/slides storage,PGX spl, spl storage for vendors,IHC,Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Medical review & Cases Data Entry.","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"MRD assessment","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"6","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing Yes Clinical chemistry Yes Clinical haematology Yes Clinical microbiology, Tumor blocks/slides storage,PGX spl, spl storage for vendors,IHC,Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Local Lab Management Sevice (iRIS)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc. (duplicate entry across regions)","duties_or_roles":"PK testing and reporting (regional entity Frontage Laboratories (Shanghai) also listed)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CC-92480
Active Substance
Mezigdomide
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational (no marketing authorisation listed)
Investigational Product Name
VELCADE 1 mg powder for solution for injection
Active Substance
Bortezomib
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketing authorisation present)
Investigational Product Name
Imnovid (pomalidomide) hard capsules
Active Substance
Pomalidomide
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation present for Imnovid formulations)
Investigational Product Name
Dexamethason / Dexamethasone (various formulations)
Active Substance
Dexamethasone
Modality
Small molecule (corticosteroid)
Routes Of Administration
ORAL / INTRAVENOUS USE (injectable formulations referenced)
Route
ORAL/INTRAVENOUS
Authorisation Status
Authorised (marketing authorisations present for listed formulations)
Combination Treatment
Yes

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