A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy

2023-503442-30-00 Protocol 64007957MMY3005 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 14 Oct 2022 · Status Ongoing, recruiting · 14 EU/EEA countries · 89 sites · Protocol 64007957MMY3005

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 1,505
Countries 14
Sites 89

Multiple Myeloma

To compare the efficacy of Tec-DR versus DRd and Tal-DR versus DRd

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
14 Oct 2022 → ongoing
Decision date (initial)
2024-09-02
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-503442-30-00
EudraCT number
2022-000909-28

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacoeconomic, Efficacy, Pharmacodynamic, Safety, Pharmacokinetic

To compare the efficacy of Tec-DR versus DRd and Tal-DR versus DRd

Conditions and MedDRA coding

Multiple Myeloma

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes
IPD plan description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparecy. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
  2. Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
  3. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  4. A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
  5. A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment

Exclusion criteria 6

  1. Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (≥)20 mg of dexamethasone within 14 days before Randomization.
  2. Had plasmapheresis within 28 days of randomization
  3. Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
  4. Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
  5. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
  6. Myeloma Frailty Index of ≥2 with the exception of participants who have a score of 2 based on age alone

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Dual primary endpoints: PFS; 12-month MRD-negative CR

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 13

Lenalidomide Mylan 15 mg hard capsules

PRD11828376 · Product

Active substance
Lenalidomide
Substance synonyms
3-(7-AMINO-3-OXO-1H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione, CDC-501, SYP-1512, CC-5013
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
L04AX04 — -
Marketing authorisation
EU/1/20/1490/012
MA holder
MYLAN PHARMACEUTICALS LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Lenalidomide Mylan 5 mg hard capsules

PRD11828369 · Product

Active substance
Lenalidomide
Substance synonyms
3-(7-AMINO-3-OXO-1H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione, CDC-501, SYP-1512, CC-5013
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
L04AX04 — -
Marketing authorisation
EU/1/20/1490/005
MA holder
MYLAN PHARMACEUTICALS LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Lenalidomide Mylan 25 mg hard capsules

PRD11828382 · Product

Active substance
Lenalidomide
Substance synonyms
3-(7-AMINO-3-OXO-1H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione, CDC-501, SYP-1512, CC-5013
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
L04AX04 — -
Marketing authorisation
EU/1/20/1490/018
MA holder
MYLAN PHARMACEUTICALS LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Lenalidomide Mylan 10 mg hard capsules

PRD11828374 · Product

Active substance
Lenalidomide
Substance synonyms
3-(7-AMINO-3-OXO-1H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione, CDC-501, SYP-1512, CC-5013
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
L04AX04 — -
Marketing authorisation
EU/1/20/1490/010
MA holder
MYLAN PHARMACEUTICALS LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Lenalidomide Accord 5 mg hard capsules

PRD6773394 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
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
L04AX04 — -
Marketing authorisation
EU/1/18/1316/004
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Lenalidomide Accord 25 mg hard capsules

PRD6773401 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
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
L04AX04 — -
Marketing authorisation
EU/1/18/1316/011
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Lenalidomide Accord 10 mg hard capsules

PRD6773397 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
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
L04AX04 — -
Marketing authorisation
EU/1/18/1316/007
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Lenalidomide Accord 15 mg hard capsules

PRD6773399 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
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
L04AX04 — -
Marketing authorisation
EU/1/18/1316/009
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

teclistamab

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

teclistamab

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

DARZALEX 1800 mg solution for injection

PRD8157846 · Product

Active substance
Daratumumab
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
L01FC01 — -
Marketing authorisation
EU/1/16/1101/004
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/13/1153
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

JNJ-64407564

PRD10381753 · Product

Active substance
Talquetamab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg/kg milligram(s)/kilogram
Max total dose
0 mg/kg milligram(s)/kilogram
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/21/2486

JNJ-64407564

PRD10381752 · Product

Active substance
Talquetamab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg/kg milligram(s)/kilogram
Max total dose
0 mg/Kg milligram(s)/kilogram
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/21/2486

Auxiliary 7

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

PRD339234 · Product

Active substance
Human Normal Immunoglobulin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENUS 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

PRD339232 · Product

Active substance
Human Normal Immunoglobulin
Substance synonyms
IMMUNOGLOBULIN HUMAN NORMAL
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

Dexamethason 8 mg GALEN® Tabletten

PRD808394 · 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
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

Dexamethason 4 mg JENAPHARM®

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

Fortecortin® 2 mg Tabletten

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
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

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

109 Total trials 22 Recruiting 86 Ended
Commercial
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 6

OrganisationCity, countryDuties
Hematogenix Laboratory Services LLC
ORG-100040020
 Tinley Park, United States Laboratory analysis
Yprime LLC
ORG-100042888
 Malvern, United States E-data capture
Almac Clinical Technologies LLC
ORG-100043036
 Souderton, United States Interactive response technologies (IRT)
Adaptive Biotechnologies Corp.
ORG-100044428
 Seattle, United States Laboratory analysis
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Parexel International Co. Ltd.
ORG-100032984
 Taipei City, Taiwan Data management

Locations

14 EU/EEA countries · 89 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 15 4
Belgium Ongoing, recruiting 30 5
Czechia Ongoing, recruiting 42 6
Denmark Ongoing, recruiting 15 4
France Ongoing, recruiting 70 12
Germany Ongoing, recruiting 46 7
Greece Ongoing, recruiting 23 3
Italy Ongoing, recruiting 50 9
Netherlands Ongoing, recruiting 30 5
Norway Ongoing, recruiting 20 2
Poland Ongoing, recruiting 80 9
Portugal Ongoing, recruiting 31 5
Spain Ongoing, recruiting 100 14
Sweden Ongoing, recruiting 16 4
Rest of world
Israel, India, Switzerland, Australia, Korea, Republic of, Brazil, China, United States, Turkey, Japan, United Kingdom, Canada
 — 937 —

Investigational sites

Austria

4 sites · Ongoing, recruiting
Medical University Of Vienna
Univ. clinic for Internal Medicine I, Department of hematology und hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Ordensklinikum Linz GmbH
Internal 1 - Hematology with stem cell transplantation, hemostaseology and medical oncology, Fadingerstrasse 1, 4020, Linz
SCRI CCCIT Ges.m.b.H.
3rd Med. Depart. Hematology, Med. Oncology, Hemostaseology, Infectious Disease and Rheumatology, Muellner Hauptstrasse 48, 5020, Salzburg
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
3. Medical department – Department of hematology & Oncology, Heinrich-Collin-Strasse 30, Penzing, Vienna

Belgium

5 sites · Ongoing, recruiting
Algemeen Ziekenhuis Groeninge
Hemotologie, President Kennedylaan 4, 8500, Kortrijk
Universitair Ziekenhuis Gent
Hematologie, Corneel Heymanslaan 10, 9000, Gent
Ziekenhuis Aan De Stroom
Hematologie, Kempenstraat 100, 2030, Antwerp
UZ Leuven
Hematologie, Herestraat 49, 3000, Leuven
Institut Jules Bordet
Hématologie, Mijlenmeersstraat 90, 1070, Anderlecht

Czechia

6 sites · Ongoing, recruiting
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
University Hospital Olomouc
Hemato-onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Plzen
Hemato-onkologicke oddeleni, Alej Svobody 923/80, 323 00, Plzen 23
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika- klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Hradec Kralove
IV.interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove

Denmark

4 sites · Ongoing, recruiting
Region Midtjylland
Klinik for Blodsygdomme, Hospitalsparken 15, 7400, Herning
Sygehus Lillebaelt Vejle Sygehus
Department Of Hematology, Kabbeltoft 25, 7100, Vejle
Næstved Hospital
Haematologisk Administrationsgang, Ringstedgade 61, 4700, Næstved
Aalborg University Hospital
Department of Hematology, Moelleparkvej 4, 9000, Aalborg

France

12 sites · Ongoing, recruiting
Les Hopitaux Universitaires De Strasbourg
Oncology and Hematology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Nantes
Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Poitiers
Hématologie et Thérapie cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Toulouse
Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Dijon
Hématologie Clinique, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Rennes
Hématologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Institut De Cancerologie Strasbourg Europe
Hématologie, 17 Rue Albert Calmette, 67200, Strasbourg
Hospices Civils De Lyon
Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Bordeaux
Hématologie clinique et de Thérapie cellulaire, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Paris
Hématologie et Thérapie cellulaire, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Lille
Hématologie, Rue Michel Polonowski, 59000, Lille
Assistance Publique Hopitaux De Paris
Hémopathies Lymphoïdes, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil

Germany

7 sites · Ongoing, recruiting
HELIOS Klinikum Berlin-Buch GmbH
Klinik Fuer Haematologie Onkologie Und Turmorimmunologie, Schwanebecker Chaussee 50, Buch, Berlin
Klinikum Nuernberg
Klinik fuer Innere Medizin 5, Schwerpunkt Onkologie/Haematologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Universitaetsklinikum Wuerzburg AöR
Med. Klinik und Poliklinik II, Abteilung fur Onkologie/Haematologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
University Medical Center Hamburg-Eppendorf
II. Med. Klinik und Poliklinik, Haematologie u. Onkologie, Martinistrasse 52, Eppendorf, Hamburg
Martin-Luther-Universitaet Halle-Wittenberg
Abt. Haematologie/Onkologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Tuebingen AöR
Abteilung fur Innere Medizin II, Hamatologie, Onkologie Rheumatololgie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen

Greece

3 sites · Ongoing, recruiting
Alexandra Hospital
Therapeutic Clinic-Oncology Department, Vassilissas Sofias Avenue 80, 115 28, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department and Bone Marrow Transplantation Unit, Exochi, 570 10, Thessaloniki
Theageneio Cancer Hospital
Hematology Clinic, Simeonidi Alex 2, 546 39, Thessaloniki

Italy

9 sites · Ongoing, recruiting
Careggi University Hospital
SOD Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
UOC Ematologia, Piazza Oms 1, 24127, Bergamo
Fondazione IRCCS Policlinico San Matteo
SC Ematologia 1, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
UOC Ematologia, Corso Bramante 88, 10126, Turin
Humanitas Mirasole S.p.A.
UOC Ematologia - Building 2, 3° piano, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Policlinico Universitario Tor Vergata
UOC Patologie Linfoproliferatve, Viale Oxford 81, 00133, Rome
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
UO Ematologia con TMO, Via Antonio Cardarelli 9, 80131, Naples
Ospedale San Raffaele S.r.l.
UO Ematologia - TMO, Via Olgettina 60, 20132, 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

Netherlands

5 sites · Ongoing, recruiting
Zuyderland Medisch Centrum Stichting
Hematologie, Dr. H. Van Der Hoffplein 1, 6162 BG, Geleen
Reinier de Graaf Groep
Hematologie, Reinier De Graafweg 5, 2625 AD, Delft
Gelre Hospitals
Hematologie, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
St. Antonius Ziekenhuis
Hematologie, Koekoekslaan 1, 3435 CM, Nieuwegein
Amsterdam UMC Stichting
Hematologie, De Boelelaan 1117, 1081 HV, Amsterdam

Norway

2 sites · Ongoing, recruiting
Oslo University Hospital HF
OMC, Taarnbygget, Kirkeveien 166, Oslo
St. Olavs Hospital HF
Of hematology, P. O. Box 3250, Torgarden, Trondheim

Poland

9 sites · Ongoing, recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Katedra I Klinika Hematologii, Transplantologii I Chorob Wewnetrznych, Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Hematologii, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddzial Hematologii I Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
N/A, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
N/A, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddzial Hematologii z Pododdziałem Chemioterapii - Klinika Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Katedra i Klinika Hematologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 11, 20-081, Lublin

Portugal

5 sites · Ongoing, recruiting
Champalimaud Clinical Centre
Unidade de Hemato-Oncologia, Avenida Brasilia S/n, 1400-038, Lisbon
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
CCAB Centro Clinico Academico Braga Associacao
Serviço de Oncologia Médica, Lugar De Sete Fontes S Victor, 4710-243, Braga
University Of Porto
Serviço de Hematologia Clínica, Alameda Professor Hernani Monteiro, 4200-319, Porto
Unidade Local De Saude De Almada-Seixal E.P.E.
Serviço de Hematologia, Avenida Torrado Da Silva, 2805-267, Almada

Spain

14 sites · Ongoing, recruiting
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Fundacio Assistencial De Mutua De Terrassa Fpc
Hematology, Calle De San Antonio No 32, 08221, Terrassa
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital De La Santa Creu I Sant Pau
Hematlogy, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario La Paz
Hematology, Paseo De La Castellana 261, 28046, Madrid
University Hospital Son Espases
Hematology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital De Jerez De La Frontera
Hematology, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Universitario De Salamanca
Hematology clinical trials, Paseo De San Vicente 58-182, 37007, Salamanca
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Virgen De Las Nieves
Hematology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Clinico Universitario De Valencia
Hematology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Hm Sanchinarro
Hematology, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona

Sweden

4 sites · Ongoing, recruiting
Region Dalarna
Medicinkliniken Hematologimottagningen, Vasagatan 27, Falu Kristine, Falun
Region Skane Skanes Universitetssjukhus
Hematologimottagning, Entregatan 7, 222 42, Lund
Region Oerebro Laen
Medicinmottagning 2, Sodra Grev Rosengatan, 701 85, Orebro
Karolinska University Hospital
Hematologiskt centrum, Halsovagen, Flemingsberg, Huddinge

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2024-06-14 2024-08-07
Belgium 2022-11-07 2023-11-14
Czechia 2023-09-18 2023-09-29
Denmark 2024-06-28 2024-08-27
France 2022-10-28 2022-11-07
Germany 2023-10-20 2023-11-20
Greece 2024-05-27 2024-08-02
Italy 2023-10-09 2023-10-30
Netherlands 2022-10-14 2022-10-25
Norway 2024-05-14 2024-06-17
Poland 2023-09-29 2023-10-03
Portugal 2024-05-17 2024-05-28
Spain 2022-11-07 2022-11-29
Sweden 2022-10-14 2022-10-25

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Urgent safety measures 1 · Art. 54 CTR

Urgent safety measure US-63560

Event date
2024-12-11
Submission date
2024-12-17
In response to
OTHER
Member states affected
Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Portugal, Spain, Sweden, Netherlands, Norway, Poland
Event description
On 19 September 2024, a comprehensive signal investigation for Ataxia and Balance Disorders was opened by the MAH after receiving reports of patients with movement disorders across multiple talquetamab clinical studies and a preliminary safety data review across the talquetamab program.

On 11 December 2024, the MAH concluded that, based on a cumulative review, the weight of the evidence suggests that the contribution of talquetamab to the events of Ataxia and Balance Disorders cannot be fully excluded. The MAH will continue to monitor and further characterize the events of interest.
Measures taken
The Sponsor decided to implement an USM for this trial on 11 December 2024. The Sponsor will send a written communication to all clinical trial investigators and sites on this topic as soon as possible. The Protocols will be amended accordingly and submitted to the Member States Concerned (MSCs) at the earliest opportunity.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 164 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_REDACTED Protocol 2023-503442-30 AM8EEA2
Protocol (for publication) D4_REDACTED PF_EORTC QLQ-C30_EN 1
Protocol (for publication) D4_REDACTED PF_EQ-5D-5L_EN 1
Protocol (for publication) D4_REDACTED PF_PRO-CTCAE_EN 1
Protocol (for publication) REDACTED_D4_PF_EORTC QLQ-C30_AT_GER_2023-503442-30 1
Protocol (for publication) REDACTED_D4_PF_EORTC QLQ-C30_BE_ara_2023-503442-30 1
Protocol (for publication) REDACTED_D4_PF_EORTC QLQ-C30_ES_MULTILINGUAL_2023-503442-30 1
Protocol (for publication) REDACTED_D4_PF_EQ-5D-5L_AT_GER_2023-503442-30 1
Protocol (for publication) REDACTED_D4_PF_EQ-5D-5L_BE_ara_2023-503442-30 1
Protocol (for publication) REDACTED_D4_PF_EQ-5D-5L_ES_MULTILINGUAL_2023-503442-30 1
Protocol (for publication) REDACTED_D4_PF_PRO-CTAE_AT_GER_2023-503442-30 1
Protocol (for publication) REDACTED_D4_PF_PRO-CTCAE_BE_ara_2023-503442-30 1
Protocol (for publication) REDACTED_D4_PF_PRO-CTCAE_ES_MULTILINGUAL_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_ Recruitment Arrangements_IT_ENG_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements _AT_ENG_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements _DE_ENG_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements _PL_POL_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements_BE_eng_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment arrangements_CZ_cze_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements_DK_Eng_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements_ES_ES_64007957MMY3005 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment arrangements_FR_FRE_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment arrangements_NL_eng_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements_NO_eng_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements_PT_ENG_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements_SE_Swe_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K1_Recruitment Arrangements_SPA_ENG_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Caregiver Brochure_CZ_CZE_64007957MMY3005 1
Recruitment arrangements (for publication) REDACTED_K2_Caregiver Brochure_NOR_no_64007957MMY3005 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Brochure_CZ_CZE_64007957MMY3005 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Brochure_NOR_no_64007957MMY3005 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material _ICF Flipchart_NO_nor_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material Booklet - Comparator Arm DRd_GR_GRE_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material Booklet - Experimental Arm Tal-DR_GR_GRE_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material Booklet - Experimental Arm Tec-DR_GR_GRE_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material Caregiver Brochure_GRC_GR_2023-503442-30-00 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material Flip Chart_GR_GRE_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material ICF Flip Chart_BE_dut_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material ICF Flip Chart_BE_eng_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material ICF Flip Chart_BE_fre_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material ICF Flip Chart_CZ_cze_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material ICF Flip Chart_DK_Dan_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material ICF Flip Chart_IT_ITA_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material ICF Flip Chart_NL_dut_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material Patient_Brochure_GRC_GR_2023-503442-30-00 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material Recruitment Brochure_PT_POR_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material Recruitment Brochure_SE_swe_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material Trintex_ES_EN_64007957MY3005 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material_Caregiver Brochure_PL_POL_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material_Recruitment Brochure_PL_POL_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material-Brochure_BE_dut_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material-Brochure_BE_eng_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material-Brochure_BE_fre_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material-Brochure_NL_dut_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material-Caregiver Brochure_BE_dut_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material-Caregiver Brochure_BE_eng_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment Material-Caregiver Brochure_BE_fre_2023-503442-30 1
Recruitment arrangements (for publication) REDACTED_K2_Recruitment material-Caregiver Brochure_NL_dut_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum _GR-GRE_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum to SRI ICF 3_DE_GER_2023-503442-30 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical Addendum PT_POR_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical PT_POR_2023-503442-30 9
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical Randomized Phase_ES_SPA_2023-503442-30 9
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical Safety Run-in_ES_SPA_2023-503442-30 9
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical_Rand_Addendum_SE_Swe_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical_Rand_SE_Swe_2023-503442-30 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Future Research_CZ_CZE_64007957MMY3005 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF genetic ICF_AT_GER_64007957MMY3005 V4AUT2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Main_GRC_GR_2023-503442-30-00 6.1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master Randomized_PL_POL_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master SRI_PL_POL_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master_DK_Dan_2023-503442-30 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master_DK_dan_2023-503442-30 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Optional Future Research_DK_dan_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF PG_GRC_GR_2023-503442-30-00 3.2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregant_GRC_GR_2023-503442-30-00 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_CZ_CZE_64007957MMY3005 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_DK_dan_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_ES_ES_64007957MMY3005 6
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_GRC_GR_2023-503442-30-00 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_NOR_no_2023-503442-30 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_PL_POL_2023-503442-30 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_PT_PT_64007957MMY3005 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_SE_SWE_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF pregnant patient ICF _DE_GER_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Patient_ES_ES_64007957MMY3005 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Privacy Appendix Randomization ICF_IT_ITA_64007957MMY3005 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Privacy Appendix Safety Run In ICF_IT_ITA_64007957MMY3005 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Privacy Language_CZ_CZE_64007957MMY3005 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Randomization ICF_IT_ITA_64007957MMY3005 6
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Randomization Main highlighted_CZ_cze_2023-503442-30 6
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Randomization Main_CZ_CZE_64007957MMY3005 6
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Safety Run In ICF_IT_ITA_64007957MMY3005 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Site Contact List_AT_Eng_6400795MMY3005 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF SRI Addendum 2_BE_ara_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF SRI Addendum 2_BE_dut_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF SRI Addendum 2_BE_fre_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF SRI Addendum 3_NL_dut_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF SRI Main highlighted_CZ_cze_2023-503442-30 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF SRI Main_CZ_CZE_64007957MMY3005 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF SRI_Addendum_SE_Swe_2023-503442-30 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal ICF_IT_ITA_64007957MMY3005 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal_ PL_POL_2023-503442-30 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal_CZ_CZE_64007957MMY3005 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal_ES_ES_64007957MMY3005 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal_GRC_GR_2023-503442-30-00 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal_PT_PT_64007957MMY3005 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_ICF randomized phase _AT_GER_64007957MMY3005 V10-11AUT1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_ICF randomized phase_DE-GER_64007957MMY3005 11
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_ICF SRI_DE_GER_64007957MMY3005 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main randomisation_FR_FRE_2023-503442-30 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main Randomization phase_NOR_no_2023-503442-30 v11NOR2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main SRI 1 Addendum 4_FR_FRE_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main SRI 1 Addendum 5_FR_FRE_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main SRI 2 and 3 Addendum 2_FR_FRE_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main SRI 2 and 3 Addendum 3_FR_FRE_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main SRI_FR_FRE_2023-503442-30 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main_SRI_SE_SWE_2023-503442-30 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Master Addendum_SRI_a_SE_SWE_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Master Addendum_SRI_b_SE_SWE_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Master Addendum_SRI_c_SE_SWE_2023-503442-30 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Optional Sample_FR_FRE_2023-503442-30 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Patient Travel Reimbursement_IT_ITA_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_PP ICF_DE_GER_64007957MMY3005 6
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_pregnant partner ICF _AT_GER_64007957MMY3005 V3AUT2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Pregnant Partner_FR_FRE_2023-503442-30 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Randomisation Addendum 1_FR_FRE_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Withdrawal ICF_AT_GER_64007957MMY3005 V2AUT2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Withdrawal ICF_DE_GER_64007957MMY3005 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Withdrawal_NOR_no_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-Main_BE_dut_2023-503442-30 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-Main_BE_fre_2023-503442-30 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-Main_NL_dut_2023-503442-30 7
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-SRI Addendum_BE_ara_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-SRI Addendum_BE_dut_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-SRI Addendum_BE_fre_2023-503442-30 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-SRI Addendum_NL_dut_2023-503442-30 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-SRI_BE_ara_2023-503442-30 3.2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-SRI_BE_dut_2023-503442-30 3.2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-SRI_BE_fre_2023-503442-30 3.2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF-SRI_NL_dut_2023-503442-30 3.6
Subject information and informed consent form (for publication) REDACTED_L2_ Subject Participation card_ AT_Ger_64007957MMY3005 3
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_CZ_CZE_64007957MMY3005 3
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_DK_Dan_2023-503442-30 3
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_FR_FRE_2023-503442-30 4
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_GRC_GR_2023-503442-30-00 3
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_IT_ITA_64007957MMY3005 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_NOR_no_64007957MMY3005 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_PL_POL_2023-503442-30 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_PT_PT_64007957MMY3005 2
Synopsis of the protocol (for publication) D1_REDACTED_Protocol Synopsis_CZ_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis ES 2023-503442-30 Am8 EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis PT 2023-503442-30 Am8 EEA
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_AT_GER_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_BE_dut_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_BE_fre_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_BE_ger_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_FR_FRE_2023-503442-30 Am8 EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_GR_2023-503442-30 Amd8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_IT_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_NL_dut_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_NO_nor_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_PL_POL_2023-503442-30 Am8-EEA2
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_SE_Swe_2023-503442-30 Am8-EEA2

Application history

11 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-27 France Acceptable
2024-08-26
 2024-08-26
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-11-06 Acceptable
2024-08-26
 2024-11-06
3 SUBSTANTIAL MODIFICATION SM-2 2024-11-06 Acceptable 2024-12-19
4 SUBSTANTIAL MODIFICATION SM-4 2025-01-30 France Acceptable
2025-05-12
 2025-05-13
5 SUBSTANTIAL MODIFICATION SM-5 2025-05-20 Acceptable 2025-07-03
6 SUBSTANTIAL MODIFICATION SM-6 2025-05-22 Acceptable 2025-07-01
7 SUBSTANTIAL MODIFICATION SM-7 2025-05-22 Acceptable 2025-07-07
8 SUBSTANTIAL MODIFICATION SM-8 2025-05-26 Acceptable 2025-07-23
9 SUBSTANTIAL MODIFICATION SM-9 2025-07-25 France Acceptable 2025-09-02
10 NON SUBSTANTIAL MODIFICATION NSM-3 2025-09-02 2025-09-02
11 SUBSTANTIAL MODIFICATION SM-10 2025-11-13 France Acceptable
2026-03-09
 2026-03-10

Related clinical trials