Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
590
Countries
13
Sites
79
Relapsed/refractory multiple myeloma
To compare the efficacy of teclistamab with PVd/Kd
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 29 Mar 2023 → ongoing
- Decision date (initial)
- 2024-07-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503444-13-00
- EudraCT number
- 2022-000928-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Others, Pharmacodynamic, Safety, Pharmacoeconomic, Pharmacogenomic, Efficacy
To compare the efficacy of teclistamab with PVd/Kd
Conditions and MedDRA coding
Relapsed/refractory multiple myeloma
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1. Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (≥)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level ≥200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain ≥10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- 2. Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
- 3. Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
- 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- 5. A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
- 6. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion criteria 6
- 1. Received any prior B cell maturation antigen (BCMA)-directed therapy
- 2. A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (≥) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade ≥3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
- 3. Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma
- 4. Received a live, attenuated vaccine within 4 weeks before randomization
- 5. Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
- 6. Received a maximum cumulative dose of corticosteroids of ≥140 mg of prednisone or equivalent within 14 days prior to randomization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- progression free survival (PFS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 16
PRD11001952 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11001954 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9260805 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
PRD11001953 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11001955 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9260804 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
PRD9260808 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
PRD9260806 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
VELCADE 3.5 mg powder for solution for injection
PRD703624 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
Dexamethason 8 mg GALEN® Tabletten
PRD808394 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 33652.01.00
- MA holder
- GALENPHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
PRD10324901 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 9587.01.00
- MA holder
- MERCK HEALTHCARE GERMANY GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
Dexamethasone Tablets BP 2.0mg
PRD3570594 · Product
- Active substance
- Dexamethasone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 39699/0056
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
PRD9936207 · Product
- Active substance
- Teclistamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 µg/Kg microgram(s)/kilogram
- Max total dose
- 0 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9936206 · Product
- Active substance
- Teclistamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 µg/Kg microgram(s)/kilogram
- Max total dose
- 0 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Kyprolis 60 mg powder for solution for infusion
PRD3374183 · Product
- Active substance
- Carfilzomib
- Substance synonyms
- PR-171
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
Auxiliary 3
Privigen 100 mg/ml solution for infusion
PRD339234 · Product
- Active substance
- Human Normal Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/Kg milligram(s)/kilogram
- Max total dose
- 0 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/08/446/001
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
Privigen 100 mg/ml solution for infusion
PRD339233 · Product
- Active substance
- Human Normal Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/Kg milligram(s)/kilogram
- Max total dose
- 0 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/08/446/002
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
Privigen 100 mg/ml solution for infusion
PRD339232 · Product
- Active substance
- Human Normal Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/kg milligram(s)/kilogram
- Max total dose
- 0 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/08/446/003
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Hematogenix Laboratory Services Limited ORG-100047188
|
Cheadle, United Kingdom | Other, Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Cellcarta Biosciences Inc. ORG-100042227
|
Montreal, Canada | Other |
| The Binding Site Group Limited ORG-100046643
|
Birmingham, United Kingdom | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Other, Code 2 |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Parexel China Co. Ltd. ORG-100043174
|
Shanghai, China | Data management, E-data capture |
Locations
13 EU/EEA countries · 79 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 8 | 2 |
| Belgium | Ongoing, recruitment ended | 20 | 5 |
| Czechia | Ongoing, recruitment ended | 13 | 4 |
| Denmark | Ongoing, recruitment ended | 19 | 6 |
| France | Ongoing, recruitment ended | 39 | 12 |
| Germany | Ongoing, recruitment ended | 33 | 8 |
| Greece | Ongoing, recruitment ended | 12 | 3 |
| Italy | Ongoing, recruitment ended | 34 | 10 |
| Netherlands | Ongoing, recruitment ended | 18 | 4 |
| Poland | Ongoing, recruitment ended | 22 | 4 |
| Portugal | Ongoing, recruitment ended | 15 | 5 |
| Spain | Ongoing, recruitment ended | 48 | 13 |
| Sweden | Ongoing, recruitment ended | 10 | 3 |
| Rest of world
Australia, China, United States, Brazil, Turkey, Israel, Malaysia, Canada, Japan, United Kingdom, India
|
— | 299 | — |
Investigational sites
Medical University Of Vienna
Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie, Waehringer Guertel 18-20, Alsergrund, Vienna
SCRI CCCIT Ges.m.b.H.
Universitaetsklinik für Innere Medizin III, Onkologisches Zentrum, Muellner Hauptstrasse 48, 5020, Salzburg
Centre Hospitalier Regional De La Citadelle
Hematology, Boulevard Du Douzieme De Ligne 1, 4000, Liege
Algemeen Ziekenhuis Klina
Hematology, Augustijnslei 100, 2930, Brasschaat
Algemeen Ziekenhuis Groeninge
Hematology, President Kennedylaan 4, 8500, Kortrijk
CHU Helora
Hematology, Rue Ferrer 159 Boite 1, 7100, La Louviere
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Vseobecna Fakultni Nemocnice V Praze
I. Interní klinika – hematologie, U Nemocnice 499/2, Nove Mesto, Prague
University Hospital Olomouc
Hemato-onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Aarhus Universitetshospital
Klinisk Forskning Blodsygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Sygehus Lillebaelt Vejle Sygehus
Dept. Of Hematology Section of Internal Medicine, Kabbeltoft 25, 7100, Vejle
Odense University Hospital
Haematologisk Forskningsenhed HFE-X, J B Winsloews Vej 4, 5000, Odense C
Aalborg University Hospital
Dept. of Hematology, Clinical Research Unit, Medicinerhuset 2, Moelleparkvej 4, 9000, Aalborg
Rigshospitalet
Dept. of Hematology, Clinical Trial Unit-2081, Blegdamsvej 9, 2100, Copenhagen Oe
Region Midtjylland
Klinik for Blodsygdomme Klinisk Forskningsenhed, Hospitalsparken 15, 7400, Herning
Hopital Saint Antoine
Service d'Hématologie et de Thérapie cellulaire, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Universitaire Grenoble Alpes
Service Hématologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
CHRU De Nancy
Hématologie - Medecine interne, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Assistance Publique Hopitaux De Paris
Service d'Hématologie, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Hospitalier Universitaire Amiens Picardie
Hématologie Clinique et Thérapie cellulaire, 30 Avenue De La Croix Jourdain, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Nantes
Service d'Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Groupement Des Hopitaux De L'Institut Catholique De Lille
Oncologie - Hématologie, Boulevard De Belfort, P. O. Box 387, Lille Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
Service d'Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Le Mans
Service d'Hématologie, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire De Caen Normandie
Clinical hematology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Assistance Publique Hopitaux De Paris
Hématologie Adultes, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Universitaire De Montpellier
Hématologie Clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Universitaetsmedizin Greifswald KöR
Klinik Innere Medizin C / Hämatologie und Onkologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik V; Haematologie,Onkologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Tuebingen AöR
Abteilung fuer Innere Medizin II; Hämatologie/Onkologie/Rheumatologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Asklepios Kliniken Hamburg GmbH
Abteilung Hämatologie und Stammzelltransplantation, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Carl-Thiem-Klinikum Cottbus gGmbH
Abteilung für Hämatologie und Onkologie, Thiemstrasse 111, Spremberger Vorstadt, Cottbus
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Heinrich-Braun-Klinikum Zwickau gGmbH
Klinik für Innere Medizin II, Karl-Keil-Strasse 35, Marienthal, Zwickau
General Hospital Of Patras Agios Andreas
Hematology Department, Kalavriton 37, 265 00, Patras
Alexandra Hospital
Therapeutic Clinic-Oncology Department of, General Hospital of Athens, Vassilissas Sofias Avenue 80, 115 28, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department - Bone Marrow Transplantation Unit, Exochi, 570 10, Thessaloniki
Azienda Ospedaliero Universitaria Pisana
Ospedale S. Chiara - UO Ematologia, Via Roma 67, 56126, Pisa
Fondazione IRCCS Istituto Nazionale Dei Tumori
Dipartimento Ematologia e Oncologia pediatrica, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Senese
UOC Ematologia, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Dipartimento Biotecnologie Molecolari e Scienze per la Salute-SC Ematologia U-Università Torino, Corso Bramante 88, 10126, Turin
Azienda Sanitaria Universitaria Friuli Centrale
Ospedale S. Maria della Misericordia - Clinica Ematologica, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda USL IRCCS Di Reggio Emilia
SC EMATOLOGIA, 2^ piano PADIGLIONE CORE, viale Risorgimento,80, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Ematologia U, Via Del Vespro 129, 90127, Palermo
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
UOS Day Hospital ematologico, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Ematologia, Viale Luigi Borri N 57, 21100, Varese
Amsterdam UMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Meander Medisch Centrum
Hematology, Maatweg 3, 3813 TZ, Amersfoort
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Katedra i Klinika Hematologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 11, 20-081, Lublin
Unidade Local De Saude De Almada-Seixal E.P.E.
Serviço de Hematologia, Avenida Torrado Da Silva, 2805-267, Almada
CCAB Centro Clinico Academico Braga Associacao
Serviço de Oncologia Médica, Lugar De Sete Fontes S Victor, 4710-243, Braga
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Hematologia e Transplantação de Medula Óssea, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Champalimaud Clinical Centre
Unidade de Hemato-Oncologia, Avenida Brasilia S/n, 1400-038, Lisbon
Unidade Local De Saude De Gaia/Espinho E.P.E.
Haematology Department, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Complexo Hospitalario Universitario De Pontevedra
Hematology, Calle Mourente S/n, 36164, Pontevedra
Hospital Universitario Infanta Leonor
Hematology, Avenida Gran Via Del Este 80, 28031, Madrid
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario De Leon
Hematology, Calle Altos De Nava S/n, 24071, Leon
Hospital Universitario Central De Asturias
Hematology, Avenida De Roma S/n, 33011, Oviedo
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital General Universitario Morales Meseguer
Hematology, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Son Llatzer
Hematology, Carretera De Manacor Km 4, 07198, Palma
Hospital De Jerez De La Frontera
Hematology, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Region Skane Helsingborg Hospital
Hematologimottagningen, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
Uppsala University Hospital
KFUE -Blod- och Tumörsjukdomar, Akademiska sjukhuset, Akademiska Sjukhuset, 751 85, Uppsala
Region Dalarna
Medicinkliniken Hematologimottagningen, Vasagatan 27, Falu Kristine, Falun
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 | 2023-11-23 | 2023-11-23 | 2025-04-03 | ||
| Belgium | 2023-04-12 | 2023-04-12 | 2025-04-03 | ||
| Czechia | 2023-09-20 | 2023-09-20 | 2025-04-03 | ||
| Denmark | 2023-05-08 | 2023-05-08 | 2025-04-03 | ||
| France | 2023-03-29 | 2023-03-29 | 2025-04-03 | ||
| Germany | 2023-05-22 | 2023-05-22 | 2025-04-03 | ||
| Greece | 2023-09-25 | 2023-09-25 | 2025-04-03 | ||
| Italy | 2023-05-12 | 2023-05-12 | 2025-04-03 | ||
| Netherlands | 2023-06-15 | 2023-06-15 | 2025-04-03 | ||
| Poland | 2023-04-18 | 2023-04-18 | 2025-04-03 | ||
| Portugal | 2023-08-31 | 2023-08-31 | 2025-04-03 | ||
| Spain | 2023-04-26 | 2023-04-26 | 2025-04-03 | ||
| Sweden | 2023-05-04 | 2023-05-04 | 2025-04-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 139 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_REDACTED Protocol 2023-503444-13 | AM5 |
| Protocol (for publication) | D4_REDACTED PF_EORTC QLQ-C30_AT_GER | 1 |
| Protocol (for publication) | D4_REDACTED PF_EORTC QLQ-C30_MULTILINGUAL | NA |
| Protocol (for publication) | D4_REDACTED PF_EQ-5D-5L_AT_GER | 1 |
| Protocol (for publication) | D4_REDACTED PF_EQ-5D-5L_MULTILINGUAL | NA |
| Protocol (for publication) | D4_REDACTED PF_MySlm-Q_AT_GER | 1 |
| Protocol (for publication) | D4_REDACTED PF_MySlm-Q_MULTILINGUAL | NA |
| Protocol (for publication) | D4_REDACTED PF_PRO-CTCAE_AT_GER | 1 |
| Protocol (for publication) | D4_REDACTED PF_PRO-CTCAE_MULTILINGUAL | NA |
| Protocol (for publication) | REDACTED_D4_PF Subj Temp Diary Celcius_BE_Dut_ 2023-503444-13 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Subj Temp Diary Celcius_BE_Fre_ 2023-503444-13 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Subj Temp Diary Celcius_NL_Dut_2023-502444-13 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary_DK_Dan_2023-503444-13 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary_GR_GRE_2023-503444-13 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary_SE_Swe_2023-503444-13 | 4 |
| Protocol (for publication) | REDACTED_D4_PF Temperature Diary_AT_GER_2023-503444-13 | 4 |
| Protocol (for publication) | REDACTED_D4_PF Temperature diary_CZ_cze_2023-503444-13 | 2 |
| Protocol (for publication) | REDACTED_D4_PF Temperature Diary_DE_GER_2023-503444-13 | 4 |
| Protocol (for publication) | REDACTED_D4_PF Temperature Diary_ES_SPA_2023-503444-13 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temperature Diary_IT_ITA_2023-503444-13 | 2 |
| Protocol (for publication) | REDACTED_D4_PF Temperature Diary_PT_POR_2023-503444-13 | 3 |
| Protocol (for publication) | REDACTED_D4_PF_temperature diary_ENG_2023-503444-13 | 3 |
| Protocol (for publication) | REDACTED_D4_PF_Temperature Diary_FR_FRE_2023-503444-13 | 2 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment Arrangements_DK_eng_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment arrangements_FR_EN_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment Arrangements_SE_eng_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangments_CZ_ENG_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arrangements _PT_ENG_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _AT_ENG_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_ES_SPA_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_IT_ENG_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Caregiver Brochure_AT_GER_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Caregiver Brochure_DE_GER_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Caregiver Brochure_GR_GRE_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material ICF Flip Chart_AT_GER_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material ICF Flip Chart_DE_GER_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material ICF Flip Chart_GR_GRE_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Recruitment Brochure_AT_GER_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Recruitment Brochure_DE_GER_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Recruitment Brochure_GR_GRE_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_App Questions_ES_SPA_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_BE_fr_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_BE_nl_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Brochure_NL_nl_64007957MMY3006 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Caregiver Brochure_PL_POL_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Content and Ads_ES_SPA_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Pre-Screening Call Script_ES_SPA_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Recruitment Brochure_PL_POL_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Service Description_ES_SPA_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Trial Details_ES_SPA_2023-503444-13 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_User App Access_ES_SPA_2023-503444-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF_IT_ITA_64007957MMY3006 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PL_POL_2023-503444-13 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Future Research Highlighted_CZ_CZE_64007957MMY3006 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Future Research_CZ_CZE_64007957MMY3006 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF GDPR _CZ_CZE_64007957MMY3006 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genetic ICF_AT_GER_64007957MMY3006 | 1.4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Highlighted_CZ_CZE_64007957MMY3006 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF main ICF_AT_GER_64007957MMY3006 | 6.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF main ICF_DE_GER_64007957MMY3006 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_CZ_CZE_64007957MMY3006 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_FR_FR_64007957MMY3006 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_GR_GRE_64007957MMY3006 | 6.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_DK_Dan_64007957MMY3006 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_ES_SPA_2023-503444-13 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_PT_ENG_2023-503444-13 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_PT_POR_2023-503444-13 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_SE_SWE_64007957MMY3006 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Future Research_DK_Dan_64007957MMY3006 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF pregnant partner ICF_AT_GER_64007957MMY3006 | 2.4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF pregnant partner ICF_DE_GER_64007957MMY3006 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_CZE_64007957MMY3006 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DK_Dan_64007957MMY3006 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2023-503444-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_FR_FR_64007957MMY3006 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_GR_GRE_64007957MMY3006 | 1.3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PL_POL_2023-503444-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PT_ENG_2023-503444-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PT_POR_2023-503444-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient_ES_SPA_2023-503444-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix Clinical ICF_IT_ITA_64007957MMY3006 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Family_IT_ITA_2023-503444-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Site Information Sheet_AT_GER_64007957MMY3006 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal ICF_ PL_POL_2023-503444-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal ICF_AT_GER_64007957MMY3006 | 2.4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal ICF_DE_GER_64007957MMY3006 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal ICF_IT_ITA_64007957MMY3006 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_CZ_CZE_64007957MMY3006 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2023-503444-13 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_FR_FR_64007957MMY3006 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_GR_GRE_64007957MMY3006 | 2.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_ENG_2023-503444-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_POR_2023-503444-13 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_BE_fr_64007957MMY3006 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_BE_nl_64007957MMY3006 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN_NL_nl_64007957MMY3006 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Participation Card-Arm A_BE_fr_64007957MMY3006 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Participation Card-Arm A_BE_nl_64007957MMY3006 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Participation Card-Arm B_BE_fr_64007957MMY3006 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Participation Card-Arm B_BE_nl_64007957MMY3006 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card A_PT_POR_2023-503444-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_AT_GER_64007957MMY3006 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_DE_GER_64007957MMY3006 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_DK_Dan_2023-503444-13 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_IT_ITA_64007957MMY3006 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_SE_Swe_2023-503444-13 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_AT_GER_64007957MMY3006 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_DE_GER_64007957MMY3006 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_DK_Dan_2023-503444-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_GR_GRE_64007957MMY3006 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_IT_ITA_64007957MMY3006 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_SE_Swe_2023-503444-13 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card B_PT_POR_2023-503444-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ARM A_CZ_CZE_64007957MMY3006 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ARM B_CZ_CZE_64007957MMY3006 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FR_64007957MMY3006 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_GR_GRE_2023-503444-13 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_POL_2023-503444-13 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_AuPI pomalidomide | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC bortezomib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC carfilzomib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC dexamethasone Merck 2mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC pomalidomide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_dexamethasone Aspen 2mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_dexamethasone Galen 8mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_dexamethasone Jenapharm 4mg | NA |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol synopsis SE 2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_de_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_fr_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_nl_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis NL_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_CZ_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_ES_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_FR_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_GR_2023-503444-13 | AM5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis_IT_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_PL_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_PT_2023-503444-13 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_AT_GER_2023-503444-13 | AM5 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-16 | France | Acceptable 2024-07-02
|
2024-07-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-10 | Acceptable | 2024-11-06 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-15 | Acceptable | 2024-11-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-02 | France | Acceptable 2025-07-28
|
2025-07-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-23 | Acceptable | 2025-10-23 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-13 | France | Acceptable 2026-03-02
|
2026-03-02 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-04-03 | France | Acceptable | 2026-05-13 |