Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
440
Countries
17
Sites
66
Relapsed or Refractory and Lenalidomide exposed Multiple Myeloma
To see if arlo-cel works better than standard treatments (Daratumumab with Pomalidomide and Dexamethasone (DPd) or Carfilzomib with Dexamethasone (Kd)) by comparing two main effectiveness measures.
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Apr 2025 → ongoing
- Decision date (initial)
- 2025-04-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Celgene Corporation
External identifiers
- EU CT number
- 2024-515279-37-00
- WHO UTN
- U1111-1308-9347
- ClinicalTrials.gov
- NCT06615479
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To see if arlo-cel works better than standard treatments (Daratumumab with Pomalidomide and Dexamethasone (DPd) or Carfilzomib with Dexamethasone (Kd)) by comparing two main effectiveness measures.
Secondary objectives 2
- To compare additional effectiveness measures between arlo-cel and standard treatments (DPd or Kd)
- To assess safety (type, frequency, and severity of side effects) and other effectiveness measures.
Conditions and MedDRA coding
Relapsed or Refractory and Lenalidomide exposed Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086466 | Relapsed/refractory multiple myeloma | 100000004848 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researches, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: "https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html"
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Have RRMM, have received 1-3 prior lines of therapy (LOT) for MM, and with proof that the disease got worse during or after the last treatment and have prior exposure to LEN.
- Have measurable signs of MM as per the study criteria.
- Be at least 18 years old and have adequate organ function and performance status as per study criteria.
Exclusion criteria 3
- Known or history of central nervous system involvement with MM.
- Solitary plasmacytomas or non-secretory MM and no other measurable signs of MM.
- Need for urgent treatment due to rapidly progressing MM.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Progression free survival (PFS): The average time participants are alive without their MM getting worse after starting the study.
- Minimal residual disease (MRD)-negative, complete response (CR): No signs of MM can be found in the participant’s body.
Secondary endpoints 2
- Overall survival (OS): The average time participants are alive after starting the study.
- Overall response rate (ORR): How many participants show a positive response to treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11660738 · Product
- Active substance
- Arlocabtagene Autoleucel
- Substance synonyms
- Autologous T-cells expressing a chimeric antigenic receptor against GPRC5D, BMS-986393, CC-95266
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0000 Other
- Max total dose
- 0000 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 13
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 999 mg/ml milligram(s)/millilitre
- Max total dose
- 999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 999 mg/ml milligram(s)/millilitre
- Max total dose
- 999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 999 mg/ml milligram(s)/millilitre
- Max total dose
- 999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 999 mg/ml milligram(s)/millilitre
- Max total dose
- 999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB175772 · Substance
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 999 mg/l milligram(s)/litre
- Max total dose
- 999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB33379 · Substance
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB33379 · Substance
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB33379 · Substance
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB33379 · Substance
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB32911 · Substance
- Active substance
- Carfilzomib
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 999 mg/ml milligram(s)/millilitre
- Max total dose
- 999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
Auxiliary 5
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB13897MIG · Substance
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION OR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 999 mg/m2 milligram(s)/sq. meter
- Max total dose
- 999 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB13897MIG · Substance
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 999 mg/m2 milligram(s)/sq. meter
- Max total dose
- 999 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
SUB20313 · Substance
- Active substance
- Tocilizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 999 mg/ml milligram(s)/millilitre
- Max total dose
- 999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelled and repackaged labelled for clinical trial use
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- Celgene Corporation
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- Celgene Corporation
Third parties 19
| Organisation | City, country | Duties |
|---|---|---|
| Clincierge ORL-000001040
|
Philadelphia, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Cellcarta Fremont LLC ORG-100042774
|
Fremont, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Olink Proteomics AB ORG-100045757
|
Uppsala, Sweden | Other |
| ProtaGene CGT GmbH ORG-100041450
|
Heidelberg, Germany | Other |
| Q2 Solutions ORL-000001988
|
United States | Other |
| Mosaic Laboratories LLC ORG-100042385
|
Lake Forest, United States | Other |
| Neogenomics Laboratories Inc. ORG-100041804
|
Aliso Viejo, United States | Other |
| Cellcarta Pty Limited ORG-100042914
|
Norwest, Australia | Other |
| Cellcarta Naperville LLC ORG-100042145
|
Naperville, United States | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Accenture Services Pvt. Ltd. ORL-000000127
|
Bengaluru, India | Other |
| Q2 Solutions ORL-000010221
|
West Lothian, United Kingdom | Other |
| Omnitrace Corp. ORG-100045579
|
Palm Beach Gardens, United States | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Other |
| Q2 Solutions, 2 Squared Solutions LLC ORL-000001473
|
Valencia, CA, United States | Other |
| Adaptive ORL-000007821
|
Seattle, United States | Other |
Locations
17 EU/EEA countries · 66 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 8 | 2 |
| Belgium | Ongoing, recruiting | 8 | 4 |
| Czechia | Ongoing, recruiting | 9 | 4 |
| Denmark | Ongoing, recruiting | 12 | 4 |
| Finland | Ongoing, recruiting | 3 | 3 |
| France | Ongoing, recruiting | 6 | 5 |
| Germany | Ongoing, recruiting | 22 | 11 |
| Greece | Ongoing, recruiting | 12 | 3 |
| Hungary | Ongoing, recruiting | 8 | 2 |
| Italy | Ongoing, recruiting | 21 | 6 |
| Netherlands | Ongoing, recruiting | 22 | 4 |
| Norway | Ongoing, recruiting | 11 | 1 |
| Poland | Ongoing, recruiting | 12 | 3 |
| Portugal | Ongoing, recruiting | 5 | 1 |
| Romania | Ongoing, recruiting | 11 | 3 |
| Spain | Ongoing, recruiting | 15 | 7 |
| Sweden | Authorised, recruiting | 4 | 3 |
| Rest of world
Argentina, United Kingdom, Australia, United States, Canada, Japan, Turkey, Switzerland, Korea, Republic of, Taiwan, Saudi Arabia, Singapore, Israel, Brazil
|
— | 251 | — |
Investigational sites
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department of Hematology and Oncology, Heinrich-Collin-Strasse 30, Penzing, Vienna
Ordensklinikum Linz GmbH
Department of Hematology and Oncology, Fadingerstrasse 1, 4020, Linz
Cliniques Universitaires Saint-Luc
Hematology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Universitair Ziekenhuis Antwerpen
Hematology, Drie Eikenstraat 655, 2650, Edegem
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika FN Brno, Jihlavska 340/20, Bohunice, Brno
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika - klinika hematologie 1.LF a VFN, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Hradec Kralove
IV. interni hematologicka klinika FN Hradec Kralove, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Odense University Hospital
Department of Hematology, J B Winsloews Vej 4, 5000, Odense C
Region Midtjylland
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Sjaelland
Department of Hematology, Vestermarksvej 6, 4000, Roskilde
Rigshospitalet
Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
HUS-Yhtymae
Comprehensive cancer center, Clinical Trial Unit, Haartmaninkatu 4, 00290, Helsinki
Oulu University Hospital
Clinical Hematology, Kajaanintie 50, 90220, Oulu
Turku University Hospital
Hematology, Hameentie 11, 20520, Turku
Hospices Civils De Lyon
Département d'hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
CHU Nantes
Service d'Hématologie, 1 Place Alexis Ricordeau, 44093, Nantes
Centre Hospitalier Universitaire De Lille
Service des Maladies du Sang, Rue Michel Polonovski, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Service clinique d'Immuno-Hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
CHU Henri Mondor
Unité Hématopathies Lymphoïdes, 1 rue Gustave Eiffel, 94010, Créteil Cedex
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Heidelberg AöR
Klinik für Hämatologie, Onkologie, Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, Johannisallee 32a, Zentrum-Südost, Leipzig
Klinikum Chemnitz gGmbH
Hematology and Oncology, Flemmingstrasse 2, Altendorf, Chemnitz
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Otto Von Guericke Universitaet Magdeburg
Hematology and Oncology, Leipziger Strasse 44, Leipziger Str., Magdeburg
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für innere Medizin II, Arnold-Heller-Strasse 3, Brunswik, Kiel
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik für Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Charite Universitaetsmedizin Berlin KöR
Hematology and Oncology, Augustenburger Platz 1, Wedding, Berlin
Klinikum Nuernberg
Medizinische Klinik 5, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
General University Hospital Of Patras
Bone Marrow Transplantation Unit, Rio, 265 04, Patras
University General Hospital Attikon
2nd Dept of Internal Medicine Division of Hematology, Rimini Street 1, 124 62, Athens
Evaggelismos Hospital
Hematology Clinic, Bοne Marrow Tranplanation Unit, Ipsiladou 45-47, 106 76, Athens
University Of Debrecen
Department of Hematology, Nagyerdei Korut 98, 4032, Debrecen
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Haematology & Stem Cell Transplantation, Albert Florian Ut 5-7, 1097, Budapest IX
Humanitas Mirasole S.p.A.
Cellular therapy and transplant unit, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione IRCCS Istituto Nazionale Dei Tumori
Dipartimento di Oncologia ed Emato-Oncologia, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Hematology U division/SSD Clinical Trial in Oncohematology and Multiple Myeloma, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattia Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
IRCCS Ospedale Policlinico San Martino
Hematology and Cell Therapy, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Sanitaria Universitaria Friuli Centrale
SOC Clinica Ematologica, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Amsterdam UMC Stichting
Hematalogy, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Utrecht
Hematalogy, Heidelberglaan 100, 3584 CX, Utrecht
Radboud universitair medisch centrum Stichting
Hematalogy, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Academisch Ziekenhuis Maastricht
Hematalogy, P Debyelaan 25, 6229 HX, Maastricht
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematologii i Transplantologii- Klinika Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Uniwersyteckie Centrum Kliniczne
Katedra i Klinika Hematologi i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Hematology and Bone Marrow Transplant Department, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Spitalul Universitar De Urgenta Bucuresti
Hematology, Splaiul Independentei 169, 050098, Bucharest
Institutul Regional De Oncologie Iasi
Hematology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institutul Clinic Fundeni
Hematology, Soseaua Fundeni 258, 022328, Bucharest
Institut Catala D'oncologia
Hematolgy, Carretera Canyet S/n, 08916, Badalona
Complexo Hospitalario Universitario De Santiago
Hematology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Virgen De Las Nieves
Hematology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
University Hospital Son Espases
Hematology, Carretera Valldemossa 79, 07120, Palma
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department of Hematology Bruna Stråket 5 413 45 Göteborg, Bla Straket 5, Goteborgs Annedal, Goteborg
Karolinska University Hospital
ME CAST (Medicinska enheten för Cellterapi och Allogen StamcellsTransplantation), Halsovagen, Flemingsberg, Huddinge
Region Skane Skanes Universitetssjukhus
VO Hematologi, Onkologi & Strålningsfysik, Entregatan 7, 222 42, Lund
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-04-17 | 2025-06-04 | |||
| Belgium | 2025-05-28 | 2025-12-15 | |||
| Czechia | 2025-06-04 | 2025-07-29 | |||
| Denmark | 2025-05-15 | 2025-06-10 | |||
| Finland | 2025-04-17 | 2025-05-12 | |||
| France | 2025-05-14 | 2025-11-27 | |||
| Germany | 2025-04-24 | 2025-05-15 | |||
| Greece | 2025-06-03 | 2025-07-02 | |||
| Hungary | 2026-02-04 | 2026-04-23 | |||
| Italy | 2025-05-27 | 2025-07-14 | |||
| Netherlands | 2025-07-09 | 2025-10-23 | |||
| Norway | 2025-04-17 | 2025-04-30 | |||
| Poland | 2025-04-17 | 2025-05-05 | |||
| Portugal | 2025-06-20 | 2025-11-11 | |||
| Romania | 2025-04-18 | 2025-05-26 | |||
| Spain | 2025-04-21 | 2025-06-24 | |||
| Sweden | 2025-05-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 191 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 01 EU GR EU CT 2024-515279-37-00_Redacted | 01 EU |
| Protocol (for publication) | D1 Protocol GR EU CT 2024-515279-37-00_Redacted | 01 |
| Protocol (for publication) | D1_Protocol_2024-515279-37-00_redacted | 01 |
| Protocol (for publication) | D4__SE_Statement on validated questionnaires under license | 1 |
| Protocol (for publication) | D4_ES_Questionnaire_EQ-5D-5L digital interviewer_Statement | NA |
| Protocol (for publication) | D4_ES_Questionnaire_EQ-5D-5L self complete_Statement | NA |
| Protocol (for publication) | D4_ES_Questionnaire_MY20_Statement | NA |
| Protocol (for publication) | D4_ES_Questionnaire_QLQ-C30 Statement | NA |
| Protocol (for publication) | D4_NL_Patient facing documents_questionnaire EQ-5D-5L Digital Interviewer Administration Statement | N/A |
| Protocol (for publication) | D4_NL_Patient facing documents_questionnaire EQ-5D-5L Digital Self-Complete Statement | N/A |
| Protocol (for publication) | D4_NL_Patient facing documents_questionnaire MY20 Statement | N/A |
| Protocol (for publication) | D4_NL_Patient facing documents_questionnaire QLQ-C30 Statement | N/A |
| Protocol (for publication) | D4_Patient facing documents redacted GR | 1 |
| Protocol (for publication) | D4_patient facing documents__questionnaires_statement_ PL | N/A |
| Protocol (for publication) | D4_Patient facing documents_Not for Publication Statement_CZ_CS_public | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire redacted placeholder_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire redacted placeholder_PT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_Statement on validated questionnaires under license_BE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Statement on validated questionnaires under license_IT | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_GER_AT | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_GER_DE | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_HU | NA |
| Recruitment arrangements (for publication) | K Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1 _FI_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1 Recruitment and IC procedure_No redaction | 2 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements_PL | V2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_AT_clean | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_AT_TC | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_DE_clean | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_DE_TC | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_PT | 2 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment and Informed consent procedure | V02 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_NL_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and IC procedure_HU_Unredacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Clean | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 2 |
| Recruitment arrangements (for publication) | K2 Recruitment material Possibia study description | 1.6 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_patient brochure_IT | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Study Intro brochure_GR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material _ Participant Letter_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient letter_AT_GER | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient letter_DE_GER | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Intro Brochure_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trifold Europe_AT_GER | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trifold Europe_DE_GER | 1 |
| Subject information and informed consent form (for publication) | L1 CA088-1007_NO_SIS-ICF Main_V4_26Nov2025_nor_clean | 4 |
| Subject information and informed consent form (for publication) | L1 CA088-1007_NO_SIS-ICF Main_V4_26Nov2025_nor_clean - Redacted | 4 |
| Subject information and informed consent form (for publication) | L1 CA088-1007_NO_SIS-ICF Main_V4_26Nov2025_nor_TC | 4 |
| Subject information and informed consent form (for publication) | L1 ICF Pharmacogenomic_HU_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Addendum_exception release_HU_Unredacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main_HU_redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Future Research_HU_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_HU_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1 SIS Pharmacogenomic_HU_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1 SIS-IC Pregnant Partner_no redaction | 2 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Exception Release_No redaction | 2 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Exception release_no redactions | 2 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Main_TC | 3 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Optional Future Research_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Pregnant Partner_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Pregnant Partner_TC | 3 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Pregnant Patient_clean_No redactions | 2 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Right not to know_No redaction | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Addendum Exception Release | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Exeptional Release_no redactions | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner_no redaction | 2 |
| Subject information and informed consent form (for publication) | L1_ES_PPP and SIS Pomalidomide | 4 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Exception release_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Main_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Optional Future Research_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Pregnant Partner_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_FI_SIS and ICF Pregnant Partner_No redactions needed | 2 |
| Subject information and informed consent form (for publication) | L1_FI_SIS and ICF_Exception Release_No redactions needed | 2 |
| Subject information and informed consent form (for publication) | L1_FI_SIS and Main IC_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF exception release_NLD | 2.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF main IC redacted_NLD | 3.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF optional future research redacted_NLD | 2.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF pregnant participant_NLD | 2.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF pregnant partner_NLD | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _Pregnant Participant_PL_ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Exception Release_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Exception Release_Clean_No redaction | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Exception Release_FR_Clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Data Protection Notice for travel assistance program_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for exception release_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Research_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partners | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Clean_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_New patients_FR_Clean_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_redacted PL_ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_PT | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Opt Future Research_FR_Clean_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant ICF_FR_Clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner _PL_ | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner ICF_FR_Clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Clean_No redaction | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PT_no redaction needed | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_exception release_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Exception Release IC_ENG_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Exception Release IC_FRA_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Exception Release IC_NLD_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_ENG_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_Eng_v1-2_sponsorstatement BMS_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_FRA_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_NLD_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner_ENG_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner_FRA_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner_NLD_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country IC Main_Redacted_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Exception Release_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Exeptional Release_clean_no readactions | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_clean_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Clean_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_already enrolled study participant_CZ_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_new participant_CZ_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_main_PL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research IC_Redacted_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_Clean_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Research_Redacted_PL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant IC_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_clean_no redactions | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner IC_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_clean_no redactions | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy notice_Redacted_IT | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement IC-via institution_Redacted_IT | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Site Contact List_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS ans ICF Exception Release_PT_no redaction needed | 2 |
| Subject information and informed consent form (for publication) | L1_SIS ans ICF Optional Future Research_Redacted_PT | 2 |
| Subject information and informed consent form (for publication) | L2 Dine rettigheder som forsgsperson i forsg med medicin_Not to be redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2 Other Subject Info PPP Pomalidomide | 4 |
| Subject information and informed consent form (for publication) | L2 Other subject info_Pomalidomide Global PPP_Adult_No redaction | 4 |
| Subject information and informed consent form (for publication) | L2_ Other subject info_Polamidomide global PPP_Clean_no redactions | 4 |
| Subject information and informed consent form (for publication) | L2_ Other subject info_Polamidomide global PPP_no redactions | 4 |
| Subject information and informed consent form (for publication) | L2_FI_Pomalidomide Global PPP_Adult_No redactions needed | 1 |
| Subject information and informed consent form (for publication) | L2_Global Pregnancy Prevention Plan_FR | 4 |
| Subject information and informed consent form (for publication) | L2_NL_Other subject information material_PPP pomalidomide_ENG | 4.0 |
| Subject information and informed consent form (for publication) | L2_NL_Other subject information material_PPP pomalidomide_patient facing section_NLD | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject info_Pomalidomide Pregnancy prevention plan_HU_Unredacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pomalidomide PPP_GR | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pomalidomide PPP_IT | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Personal Data Processing_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pomalidomide Global PPP Adult_RO | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PPP_CZ | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PPP_PT_no redaction needed | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Pomalidomide Global PPP_Adult_PL | 4 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_Global_PPP_ADULT_BE_ENG_for publication | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_Global_PPP_ADULT_BE_FRA_for publication | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_Global_PPP_ADULT_BE_NLD_for publication | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Pomalidomide_PPP | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Alert Card_HU_redacted | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carfilzomib_Kyprolis_Amgen | 21 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daratumumab sol for infusion_injection DARZALEX Janssen | 25 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daratumumab sol for infusion_injection DARZALEX Janssen_Summary_of_changes | 25 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daratumumab sol for infusion_injection DARZALEX Janssen_TC | 25 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dexamethason-ratiopharm_4 mg_8 mg Tablet | 7 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fortecortin Inject 4_8_40_100 mg_Merck Healthcare Germany | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pomalidomide_Imnovid_Bristol-Myers Squibb | 25 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pomalidomide_Imnovid_Bristol-Myers Squibb summary of changes | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis EU CT 2024-515279-37-00_PT | 4 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis GR 2024-515279-37-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis_NO_2024-515279-37 | 4 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis_pl 2024-515279-37_PL | 4.0 |
| Synopsis of the protocol (for publication) | D1_ES_Protocol synopsis_2024-515279-37-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-515279-37_CZ | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-515279-37_NLD | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515279-37_BE_FRE | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515279-37_BE_GER | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515279-37_BE_NLD | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-515279-37_clean_GER_AT | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515279-37_Clean_SE | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515279-37_FR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515279-37_IT | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515279-37_RO | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515279-37-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2024-515279-37_HU | 4 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-22 | Denmark | Acceptable with conditions 2025-03-31
|
2025-03-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-08 | Acceptable with conditions 2025-03-31
|
2025-04-08 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-24 | Acceptable with conditions 2025-03-31
|
2025-04-24 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-25 | Acceptable with conditions | 2025-05-15 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-29 | Acceptable with conditions | 2025-06-04 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-29 | Acceptable with conditions | 2025-05-05 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-30 | Acceptable with conditions | 2025-06-16 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-16 | Denmark | Acceptable with conditions | 2025-05-30 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-24 | 2025-06-24 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-29 | Denmark | Acceptable 2025-11-03
|
2025-11-03 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-11 | Acceptable 2025-11-03
|
2025-11-11 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-03 | Denmark | Acceptable 2026-03-13
|
2026-03-13 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-04-08 | Acceptable 2026-03-13
|
2026-04-08 |