Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
654
Countries
16
Sites
116
follicular lymphoma (FL) and marginal zone lymphoma (MZL)
To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab to the efficacy of placebo and lenalidomide in addition to rituximab in participants with relapsed/ refractory (R/R) FL.
Key facts
- Sponsor
- Incyte Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Jun 2021 → ongoing
- Decision date (initial)
- 2024-01-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Incyte Corporation, United States
External identifiers
- EU CT number
- 2023-504684-16-00
- EudraCT number
- 2020-004407-13
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy, Others, Pharmacodynamic
To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab to the efficacy of placebo and lenalidomide in addition to rituximab in participants with relapsed/ refractory (R/R) FL.
Secondary objectives 1
- 1. To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab versus placebo and lenalidomide in addition to rituximab in the overall population (FL and MZL) 2. To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab versus placebo and lenalidomide in addition to rituximabin terms of PET-CR rate in FDG-avid FL participants and OS in the FL population.
Conditions and MedDRA coding
follicular lymphoma (FL) and marginal zone lymphoma (MZL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10076596 | Marginal zone lymphoma | 100000004864 |
| 20.1 | LLT | 10080213 | In situ follicular lymphoma | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment phase 2 groups receiving either Tafasitamab plus lenalidomide and rituximab or placebo plus lenalidomide and rituximab stratified by factors depending on disease (FL or MZL)
|
Randomised Controlled | Double | [{"id":184195,"code":4,"name":"Analyst"},{"id":184196,"code":3,"name":"Monitor"},{"id":184197,"code":1,"name":"Subject"},{"id":184194,"code":5,"name":"Carer"},{"id":184198,"code":2,"name":"Investigator"}] | Group A: "group is receiving: • Tafasitamab (12 mg/kg IV), 28-day cycle − Cycles 1 to 3: Days 1, 8, 15, and 22 − Cycles 4 to 12: Days 1 and 15 • Rituximab (including biosimilars; 375 mg/m2 IV), 28-day cycle − Cycle 1: Days 1, 8, 15, and 22 − Cycles 2 to 5: Day 1 • Lenalidomide (including generics; 20 mg PO once daily), 28-day cycle − Cycles 1 to 12: Days 1 to 21" Group B: "group is receiving: • Tafasitamab placebo (0.9% saline solution) IV, 28-day cycle − Cycles 1 to 3: Days 1, 8, 15, and 22 − Cycles 4 to 12: Days 1 and 15 • Rituximab (including biosimilars; 375 mg/m2 IV), 28-day cycle − Cycle 1: Days 1, 8, 15, and 22 − Cycles 2 to 5: Day 1 • Lenalidomide (including generics; 20 mg PO once daily), 28-day cycle − Cycles 1 to 12: Days 1 to 21" |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- Undecided
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Male and female participants at least 18 years of age who have a histologically confirmed Grade 1, 2 or 3a FL or histologically confirmed nodal MZL, splenic MZL, or extranodal MZL 2. Must have been previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments such as rituximab monotherapy or chemotherapy plus immunotherapy with rituximab or obinutuzumab, with or without maintenance. 3. Must have documented relapsed, refractory, or progressive disease (PD) after treatment with systemic therapy a. Relapsed lymphoma: relapsed after initial response of CR or PR ≥ 6 months after prior therapy. b. Refractory lymphoma: achieved less than PR to the last treatment or achieved a CR or PR that lasted less than 6 months. c. Progressive lymphoma: PD after initial response of SD to prior therapy. Please refer to section 5.1 of the protocol for the full list of inclusion criteria.
Exclusion criteria 1
- 1. Women who are pregnant or breastfeeding. 2. History of or current histology other than FL and MZL or clinical evidence of transformed lymphoma by investigator (INV) assessment. 3. History of radiation therapy to ≥ 25% of the BM for other diseases. 4. Active systemic infection. 5. Participants in a severely immunocompromised state. 6. Known CNS lymphoma involvement. Please refer to section 5.2 of the protocol for the full list of exclusion criteria.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS by investigator (INV) assessment in the FL population, using Lugano 2014 criteria (Cheson et al 2014). PFS is defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.
Secondary endpoints 1
- * PFS by INV assessment in the overall population (FL and MZL populations). * PET-CR rate by INV in the FDG-avid FL population, defined as a complete metabolic response at any time after start of treatment. *OS in the FL population.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
PRD9264292 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/010
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264287 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/008
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264307 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/013
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264288 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/011
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264267 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/009
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MINJUVI 200 mg powder for concentrate for solution for infusion
PRD9171980 · Product
- Active substance
- Tafasitamab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 12 mg/Kg milligram(s)/kilogram
- Max total dose
- 380 mg/kg milligram(s)/kilogram
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FX12 — -
- Marketing authorisation
- EU/1/21/1570/001
- MA holder
- INCYTE BIOSCIENCES DISTRIBUTION B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/14/1424
- Modified vs. Marketing Authorisation
- No
PRD8721724 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00505
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8721745 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00502
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8721743 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00506
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8721704 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00504
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 100 mg concentrate for solution for infusion
PRD5065907 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 3000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 113 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/002
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Incyte Corp.
- Sponsor organisation
- Incyte Corp.
- Address
- 1801 Augustine Cut Off
- City
- Wilmington
- Postcode
- 19803-4404
- Country
- United States
Scientific contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Massive Bio Inc. ORG-100044618
|
New York, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Neogenomics Laboratories Inc. ORG-100041804
|
Houston, United States | Other |
| Universitaetsklinikum Schleswig-Holstein ORG-100023619
|
Kiel, Germany | Other |
| Neogenomics Laboratories Inc. ORG-100041804
|
San Diego, United States | Other |
| Inivata Limited ORG-100046830
|
Cambridge, United Kingdom | Other |
| Iqvia Laboratories Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Neogenomics Laboratories Inc. ORG-100041804
|
Aliso Viejo, United States | Other |
| Syneos Health Hellas Single Member S.A. ORG-100043210
|
Vrilissia, Greece | On site monitoring, Code 12, Code 5 |
| Eurofins Adme Bioanalyses ORG-100034510
|
Vergeze, France | Other |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 12, Code 2, Code 5, Data management, E-data capture |
Locations
16 EU/EEA countries · 116 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 18 | 5 |
| Belgium | Ongoing, recruitment ended | 36 | 9 |
| Czechia | Ongoing, recruitment ended | 27 | 4 |
| Denmark | Ongoing, recruitment ended | 5 | 1 |
| Finland | Ongoing, recruitment ended | 12 | 5 |
| France | Ongoing, recruitment ended | 16 | 12 |
| Germany | Ongoing, recruitment ended | 8 | 4 |
| Greece | Ongoing, recruitment ended | 31 | 4 |
| Hungary | Ongoing, recruitment ended | 17 | 7 |
| Ireland | Ongoing, recruitment ended | 2 | 1 |
| Italy | Ongoing, recruitment ended | 60 | 24 |
| Netherlands | Ongoing, recruitment ended | 9 | 4 |
| Norway | Ongoing, recruitment ended | 5 | 2 |
| Poland | Ongoing, recruitment ended | 10 | 7 |
| Spain | Ongoing, recruitment ended | 83 | 25 |
| Sweden | Ongoing, recruitment ended | 6 | 2 |
| Rest of world
Canada, Israel, Taiwan, Australia, Switzerland, Korea, Republic of, United Kingdom, Turkey, Japan, United States
|
— | 309 | — |
Investigational sites
Kepler Universitaetsklinikum GmbH
Department of Internal Medicine I, Krankenhausstrasse 9, 4020, Linz
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
3rd Medical Division, Heinrich-Collin-Strasse 30/1100, Penzing, Vienna
Medical University Of Vienna
Department of Internal Medicine I, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Graz
University Hospital of Internal Medicine, Neue Stiftingtalstrasse 6, 8010, Graz
Medizinische Universitaet Innsbruck
Internal Medicine 5, Anichstrasse 35, 6020, Innsbruck
CHU De Liege
Hematology, Avenue De L'hopital 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Hematology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Het Ziekenhuisnetwerk Antwerpen
Hematology, Kempenstraat 100, 2030, Antwerp
UZ Leuven
Hematology – Internal Medicine, Herestraat 49, 3000, Leuven
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Hematology, Rue Heger Bordet 1, 1000, Brussels
UCL Mont-Godinne
Hematology, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
Algemeen Ziekenhuis Delta
Hematology, Deltalaan 1, 8800, Roeselare
Fakultní Nemocnice Královské Vinohrady
Hematologicka klinika, Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Nemocnice Hradec Kralove
4. interni a hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika VFN a 1. LF UK, U Nemocnice 499/2, Nove Mesto, Prague 2
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, 708 00, Poruba
HUS-Yhtymae
Dept of Oncology, Haartmaninkatu 4, 00290, Helsinki
Kuopio University Hospital
Dept of Oncology, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Turku University Hospital
Dept of Oncology, Kiinamyllynkatu 4-8, 20520, Turku
Oulu University Hospital
Dept of Oncology, Kajaanintie 50, 90220, Oulu
Tampere University Hospital
Dept of Oncology, Elamanaukio 2, 33520, Tampere
Centre Hospitalier Regional Universitaire De Tours
Service d’hematologie et Therapie Cellulaire, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Hopital Universitaire Pitie Salpetriere
Service d’Hematologie – Clinique Georges Heuyer, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Assistance Publique Hopitaux De Paris
Service d’Hematologie du Pr. Bouscary, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Hopital NOVO
Service Hematologie Clinique et Therapie Cellulaire, 6 Avenue De L Ile De France, 95300, Pontoise
Centre Hospitalier Yves Le Foll
Service d Hematologie, 10 Rue Marcel Proust, 22000, Saint-Brieuc
Centre Hospitalier Annecy Genevois
N/A, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Centre Hospitalier Universitaire De Dijon
Service Hematologie Clinique, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire D'Angers
Service des Maladies du sang, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Nantes
Service d’hematologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Hopital Saint Louis
Service d’Onco-Hematologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier De Versailles
Service d hematologie et oncologie, 177 Rue De Versailles, Le Chesnay, Le Chesnay Rocquencourt
Centre Hospitalier Universitaire Amiens Picardie
Service d’hematologie clinique et Therapie cellulaire, 30 Avenue De La Croix Jourdain, 80054, Amiens Cedex 1
Vivantes Netzwerk fuer Gesundheit GmbH
Clinic for Internal Medicine, Hematology and Oncology, Dieffenbachstrasse 1/1, Kreuzberg, Berlin
Universitaet Muenster
Medical Clinic A, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Essen AöR
Clinic for Hematology and Stem Cell Transplantation, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Wuerzburg AöR
Center for Internal Medicine Medical Clinic and Polyclinic II, Outpatient Clinic Hematology/Oncology, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Hematology Department, Rimini 1, 124 61, Chaidari
General University Hospital Of Patras
Haematology Department of the Clinic of Internal Medicine, Rio, 265 04, Patras
251 Air Force General Hospital
Haematology Department, Kanellopoulou Avenue 3, 115 25, Athens
Laiko General Hospital Of Athens
1st Department of Propaedeutic Internal Medicine, Sevastoupoleos 16, 115 26, Athens
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Hematology Department, Szent Istvan Utca 68, 4400, Nyiregyhaza
University Of Debrecen
Internal Medicine Clinic B building Hematology, Nagyerdei Korut 98, 4032, Debrecen
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Hematology department, Tallian Gyula Utca 20-32, 7400, Kaposvar
Orszagos Onkologiai Intezet
"A" Internal Medicine Oncology and Hematology Department, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Semmelweis University
Clinic of Internal Medicine and Hematology, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
University Of Szeged
Hematology Department, Semmelweis Utca 8, 6725, Szeged
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department of Internal Medicine, Knezich Karoly Utca 1, 3300, Eger
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Hematology, Corso Giuseppe Mazzini 18, 28100, Novara
Fondazione IRCCS Istituto Nazionale Dei Tumori
Hematology, Via Giacomo Venezian 1, 20133, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Hematology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliera Universitaria Federico II Di Napoli
Hematology, Via Sergio Pansini 5, 80131, Naples
Azienda USL IRCCS Di Reggio Emilia
SC Ematologia, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Hematology, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Hematology, Corso Bramante 88, 10126, Turin
Azienda Sanitaria Universitaria Giuliano Isontina
Hematology, Via Costantino Costantinides 2, 34128, Trieste
Azienda Ospedaliera S Maria Di Terni
Hematology, Viale Tristano Di Joannuccio 1, 05100, Terni
Azienda Unita Sanitaria Locale Di Piacenza
Hematology, Via Giuseppe Taverna 49, 29121, Piacenza
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Hematology, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Hematology, Via Venezia 16, 15121, Alexandria
Ospedale Vito Fazzi Lecce
Hematology, Piazza Filippo Muratore 1, 73100, Lecce
Azienda Unita Sanitaria Locale Della Romagna
Hematology unit, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione IRCCS Policlinico San Matteo
Hematology, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Hematology, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Hematology, Via Trabucco 180, 90146, Palermo
Hospital Santa Maria Della Misericordia
Hematology, Piazzale Giorgio Menghini 1, 06129, Perugia
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Hematology, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Azienda Unita Sanitaria Locale Della Romagna
Hematology, Viale Luigi Settembrini 2, 47923, Rimini
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Hematology, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero Universitaria Pisana
Hematology, Via Roma 67, 56126, Pisa
ASST Grande Ospedale Metropolitano Niguarda
Hematology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Ospedale S. Eugenio
Hematology, PIAZZALE DELL'UMANESIMO 10, 00144, ROMA
Amsterdam UMC
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Rijnstate Ziekenhuis Stichting
Hematology, Wagnerlaan 55, 6815 AD, Arnhem
Medisch Centrum Leeuwarden B.V.
Hematology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Medical Center Haaglanden
Hematology, Burgemeester Banninglaan 1, 2262 BA, Leidschendam
St. Olavs Hospital HF
Kreftkliniken, Prinsesse Kristinas G. 3, 7030, Trondheim
Oslo University Hospital HF
Dept. of Oncology, Taarnbygget, Kirkeveien 166, Oslo
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematoonkologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 16, 20-081, Lublin
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
i Chorob Wewnetrznych, Ul. Macieja Jakubowskiego 2, 30-688, Krakow
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematologii Ogólnej, Ul. Pabianicka 62, 93-513, Lodz
Pratia S.A.
N/A, Ul. Gryfinska 1, 60-192, Poznan
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Hospital Universitario Dr Peset Aleixandre
Hematology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitario Araba
Hematology, Jose Achotegui Kalea S/N, 01009, Vitoria
Hospital Son Llatzer
Hematology, Carretera De Manacor Km 4, 07198, Palma
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Y Politecnico La Fe
Hematology and Hemotherapy, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario De Burgos
Hematology and Hemotherapy, Avenida De Las Islas Baleares 3, 09006, Burgos
Institut Catala D'oncologia
Clinical Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario De Cabuenes
Hematology, Calle Prados 395, Cabuenes, Gijon
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Fundacio Assistencial De Mutua De Terrassa Fpc
Hematology, Calle De San Antonio No 32, 08221, Terrassa
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
University Clinical Hospital Virgen De La Arrixaca
Hematology and Hemotherapy, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Marques De Valdecilla
Hematology and Hemotherapy, Avenida Valdecilla Sn, 39008, Santander
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital De La Santa Creu I Sant Pau
Hematology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital General Universitario Dr. Balmis
Medical Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Del Mar
Clinical Hematology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Donostia
Hematology, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
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 | 2021-08-17 | 2021-08-17 | 2023-06-27 | ||
| Belgium | 2021-06-22 | 2021-07-07 | 2023-06-22 | ||
| Czechia | 2021-12-17 | 2022-01-12 | 2023-07-19 | ||
| Denmark | 2021-12-14 | 2021-12-29 | 2023-03-29 | ||
| Finland | 2021-10-25 | 2021-11-17 | 2023-07-18 | ||
| France | 2021-06-05 | 2021-09-08 | 2023-07-11 | ||
| Germany | 2022-05-20 | 2022-07-05 | 2023-06-05 | ||
| Greece | 2021-07-05 | 2021-07-22 | 2023-07-27 | ||
| Hungary | 2021-09-03 | 2021-10-22 | 2023-07-27 | ||
| Ireland | 2021-10-14 | 2022-02-02 | 2022-12-22 | ||
| Italy | 2021-10-06 | 2021-12-09 | 2023-07-13 | ||
| Netherlands | 2021-09-21 | 2021-11-05 | 2023-01-02 | ||
| Norway | 2022-01-22 | 2022-03-01 | 2023-07-03 | ||
| Poland | 2021-08-31 | 2021-12-21 | 2023-07-14 | ||
| Spain | 2021-06-10 | 2021-06-22 | 2023-07-20 | ||
| Sweden | 2022-04-26 | 2022-06-07 | 2023-06-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 355 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-504684-16-00_eCRF_redacted | 2.0 |
| Protocol (for publication) | D1_Protocol_2023-504684-16-00_placebo justification_redacted | 1 |
| Protocol (for publication) | D1_Protocol_2023-504684-16-00_redacted | PA7, V8 |
| Protocol (for publication) | D1_Protocol_EL_2023-504684-16-00_redacted | PA7, V8 |
| Protocol (for publication) | D2_Protocol_admin change 3_2023-504684-16-00 | N/A |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Digital Self-Complete Tablet_FR-FRE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Digital Self-Complete_tablet_BE-DUT | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Digital Self-Complete_tablet_BE-FRE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Paper Self-Complete_AT-GER | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Paper Self-Complete_BE-DUT | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Paper Self-Complete_BE-FRE | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Paper Self-Complete_CZ | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Paper Self-Complete_EL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Paper Self-Complete_FR-FRE | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Paper Self-Complete_HUN | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Paper Self-Complete_NL-DUT | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_ Digital Self complete Tablet_AT-GER | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self complete Tablet_NL-DUT | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self-Complete Tablet_CZ | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self-Complete Tablet_DE-GER | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self-Complete Tablet_DK | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self-Complete Tablet_EL | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self-Complete Tablet_FI-FIN | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self-Complete Tablet_FI-SV | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self-Complete Tablet_ITA | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Digital Self-Complete Tablet_SE-SV | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Final Report_AT-GER | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Final Report_HUN | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Final Report_IE-ENG | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Final Report_NO | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_Final Report_POL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_CZ | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_DK | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_DUT | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_EL | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_FIN | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_Final Report_AT-GER | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_Final Report_HUN | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_Final Report_IE-ENG | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_Final Report_NO | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_Final Report_POL | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_FRE | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_GER | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_ITA | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACT-Lym_SV | 4 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_CZ | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_DK | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_DUT | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_EL | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_FIN | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_Final Report_AT-GER | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_Final Report_HUN | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_Final Report_IE-ENG | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_Final Report_NO | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_Final Report_POL | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_FRE | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_GER | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_ITA | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_SV | 3 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank Document | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank document | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank Document | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank document_FI | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank document_GR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank document_NO | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank document_SE | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank_BE | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank_CZ | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DK_BLANK | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Dr to Dr letter_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_eNewsletter | 0.2.2 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Flowchart | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_PAG_study_fact_sheet_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Patient Brochure_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_patient_FAQ_brochure_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Site to PAG letter | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Social Media Ad_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Web Banner Ad_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material trial_Dosing diary Lenalidomide | 1.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_ Dosing Diary Lenalidomide _DK | 1.1.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_ Patient emergency card _DK | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_ Visit Reminder Card _DK | 1.1.0 |
| Recruitment arrangements (for publication) | K2_Other patient facing material_Flowchart _DK | 3.0 |
| Recruitment arrangements (for publication) | K2_Other patient facing material_Study participant guide_DK | 3.0 |
| Recruitment arrangements (for publication) | K2_Other Subject information material_Participant Guide | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_Dr-Dr letter_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_eNewsletter_IT | 0.2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_FAQ_brochure_IT | 1.1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_PAG pat_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_PAG_site_letter_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_PAG_study_IT | 1.1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_patient_brochure_IT | 1.1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_social_media_ads_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment mat_web_banner_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_Dr to dr letter | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_eNewsletter content | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_flowchart | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_GP letter | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_PAG study fact sheet | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_PAG to patient letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_Participant guide | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_Patient Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_patient_FAQ_brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_Site to PAG letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material trial_Visit reminder card | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ chart review checklist | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ eNewsletter content | 0.2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ eNewsletter Content_CZ | 0.2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ PAG study fact sheet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ PAG to patient letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ patient brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ patient FAQ brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ site to PAG letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ social media ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ web banner ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_chart review checklist_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_dr to dr letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_dr to dr letter_CZ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_dr to dr letter_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr letter_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_eNewsletter | 0.2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_eNewsletter | 0.2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_eNewsletter content | 0.2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_eNewsletter content_PL | 0.2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_eNewsletter_NL | 0.2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FAQ_brochure_NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_flowchart_FR | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchart_NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_flowchart_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GDP Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GDP study factsheet_FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_other subject information material chart review checklist_GR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_other subject information material dr to dr letter_GR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_other subject information material site staff welcome letter GR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_other subject information material toolkit sheet_GR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_other subject information material trial card pocketsize_GR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PAG study fact sheet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PAG study fact sheet_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PAG to patient letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PAG to patient letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PAG to patient letter_CZ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PAG to patient letter_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient brochure_CZ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient brochure_NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient brochure_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient FAQ brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient FAQ brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient FAQ brochure_CZ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient FAQ brochure_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_site staff welcome letter_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_site to PAG letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_site to PAG letter_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_social media ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social media ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_social media ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ads_CZ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social media ads_NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_social media ads_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Fact Sheet_CZ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_study participant guide_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_toolkit sheet_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_trial card pocketsize_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_trial card_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Visit reminder card_FR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Web banner | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_web banner ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Web banner ad_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Web banner_CZ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment matieral_PAG to Pt Letter_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional Biopsy and Mandatory Genomic Testing | 2.3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _ Add Opt Tissue Biopsy_Redacted | 2.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _ Pregnant Partner | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _Main_Radacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_PL_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Add Opt Tissue Biopsy_IT | 2.1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Genomic Testing _GR | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Optional Tissue Biopsy Collection_GR | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Payment Reimbursement Greenphire_GR | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_DUT_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_ENG_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_FRE_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_IE_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_AddGenomic Test_IT | 2.1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main 539 PI Trneny ongoing patients_CZ_Redacted | 8.1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main 539 PI Trneny_Redacted | 9.1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ongoing patients_CZ_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ BE-FR_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-EN_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-NL_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_clean_Redacted | 9.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DK_Redacted | 9.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_GR_ Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_IRL | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_IT_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_main_NL_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NO_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted_FI | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted_HU | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted_SE | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Tissue Biopsy | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Tissue Biopsy 539 PI Trneny_CZ_Redacted | 2.2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Tissue Biopsy ongoing patients_CZ | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Tissue Biopsy PI Trneny ongoing patients_CZ_Redacted | 2.2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Tissue Biopsy_CZ | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Tissue Biopsy_FR_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Partner_FI_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_DUT_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_ENG_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_FRE_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_IT | 2.1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnancy_NL_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ongoing patients_CZ | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DK | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FR_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_GR | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_IE_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_NO | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_SE | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy Notice ongoing patients_CZ | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy Notice_CZ | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Site details_Redacted | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_soc main_NL | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Main_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Optional Biopsy and Mandatory Genomic Testing | 2.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Pregnant Partner | 2.2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Lenalidomide Counselling Form_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dosing Diary_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_flowchart_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participants Giude_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Reminder Card_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ flowchart | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ Greenphire ClinCard Cardholder_GR | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ Greenphire ClinCard Msg Templates _GR | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ Greenphire EU Generic ClinCard _GR | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ Greenphire Fee Schedule_GR | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ Patient Emergency | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ Reminder Card_GR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ study participant guide | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ Visit Reminder Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ClinCard EC Submission_FR_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Diary_FI | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dosing Diary | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dosing Diary | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Dosing Diary_Lenalidomide_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dr to Dr letter_NO_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency card | 2.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency card_SE | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eNewsletter content_NO | 0.2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eNewsletter content_SE | 0.2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EORTC-QLQ-C30_SE | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EQ-5D-5L_NO | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EQ-5D-5L_SE | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FACT-Lym_NO | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FACT-Lym_SE | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_flowchart | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Flowchart | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_flowchart_FI | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Flowchart_NO | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Flowchart_SE | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter | 2.1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_GP Letter_FR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Greenphire ClinCard Card Carrier_FR_Redacted | N/A |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Greenphire ClinCard Card Carrier_GR | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Greenphire ClinCard Cardholder FAQ_FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Greenphire ClinCard standard message_FR_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Greenphire EU ClinCard_FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Greenphire Fee Schedule_FR | N/A |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Greenphire Memo_FR_Redacted | N/A |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Greenphire_FR_Redacted | N/A |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_inMIND Trial Card_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PAG study fact sheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PAG study fact sheet_FI_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_PAG study fact sheet_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PAG study fact sheet_NO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PAG to patient letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PAG to patient letter_FI | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PAG to patient letter_NO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_patient brochure | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_patient brochure_FI_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Brochure_NO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient brochure_SE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Patient card_FR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient emergency card_FI | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient emergency card_NO | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_patient FAQ brochure | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_patient FAQ brochure_FI_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_patient FAQ brochure_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient FAQ brochure_NO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient FAQ brochure_SE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient letter_SE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QLQ-C30_NO | N/A |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Rights_DK | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_site to PAG letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_site to PAG letter_FI | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Site to PAG letter_NO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_social media ads_FI_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Social media ads_NO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Social media ads_SE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_study participant guide | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study participant guide | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_study participant guide_FI_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_study participant guide_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study participant guide_NO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study participant guide_SE | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Reminder Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Reminder Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit reminder card_FI | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Reminder Card_NO | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_web banner ad_FI_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_web banner ad_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Web banner ad_SE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Website Banner Ad_NO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Flowchart_BE-EN | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Flowchart_BE-FR | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Flowchart_BE-NL | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Study Guide_BE-EN | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Study Guide_BE-FR | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Study Guide_BE-NL | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Visit reminder card_SE | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Revlimid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Truxima | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Zelvina | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT-GER_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DUT_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FRE_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-GER_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ-CZE_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES-SPA_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FRE_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR-EL_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU-HUN_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT-ITA_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL-DUT_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO-NO_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL-POL_2023-504684-16-00 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE-SV_2023-504684-16-00 | N/A |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-16 | Belgium | Acceptable 2024-01-15
|
2024-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-30 | Belgium | Acceptable 2024-07-09
|
2024-07-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-29 | Belgium | Acceptable 2025-04-23
|
2025-04-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-12 | Acceptable | 2025-07-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-21 | Acceptable | 2025-09-26 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-22 | Acceptable | 2025-10-02 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-22 | Belgium | Acceptable with conditions 2026-04-08
|
2026-04-08 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-04-30 | Acceptable with conditions | 2026-05-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-04-30 | Acceptable with conditions | 2026-05-25 |