Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
932
Countries
13
Sites
74
Relapsed or Refractory Myeloma
To compare the efficacy of either Tal-P or Tal-Tec with EPd or PVd
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Feb 2024 → ongoing
- Decision date (initial)
- 2024-02-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacodynamic, Therapy, Others, Safety, Pharmacokinetic
To compare the efficacy of either Tal-P or Tal-Tec with EPd or PVd
Conditions and MedDRA coding
Relapsed or Refractory Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10035226 | Plasma cell myeloma | 100000004864 |
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 5
- Be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.
- Documented multiple myeloma as defined by the criteria below: a. Multiple myeloma diagnosis according to the IMWG diagnostic criteria. b. Measurable disease at screening as assessed by central laboratory, defined by any of the following: 1. Serum M-protein level ≥0.5 g/dL (central laboratory); or 2. Urine M-protein level ≥200 mg/24 hours (central laboratory); or 3. Light chain multiple myeloma without measurable M protein in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio (central laboratory)
- Relapsed or refractory disease as defined below: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment. b. Refractory disease is defined as <25% reduction in M-protein or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment.
- Documented evidence of progressive disease or failure to achieve a minimal response to the last line of therapy based on investigator’s determination of response by IMWG criteria on or after their last regimen.
- Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment.
Exclusion criteria 5
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the talquetamab IB, teclistamab IB, and appropriate prescribing information).
- Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF.
- Presence of the following cardiac conditions: a. New York Heart Association Class III or IV congestive heart failure b. Myocardial infarction, unstable angina, or coronary artery bypass graft ≤6 months prior to randomization c. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d. History of severe non-ischemic cardiomyopathy
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.
- Prior or concurrent exposure to any of the following, in the specified time frame prior to randomization: o T cell redirection therapy (for example, antibody therapy or BiTEs) within 3 months o Gene-modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, NK cells) within 3 months o Targeted therapy, epigenetic therapy, mAb therapy, cytotoxic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less o Investigational vaccine other than SARS CoV-2 vaccine approved or authorized for emergency use within 4 weeks o Live, attenuated vaccine within 4 weeks. Non-live and non-replicating vaccines approved or authorized for emergency use (e.g., COVID-19) by local health authorities are allowed. o PI therapy within 14 days o IMiD agent therapy within 14 days o Focal radiation within 7 days
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-Free Survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 18
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
- 20 mg milligram(s)
- Max total dose
- 760 mg milligram(s)
- Max treatment duration
- 24 Month(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
- No
PRD11001953 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 2184 mg milligram(s)
- Max treatment duration
- 24 Month(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
- 4 mg milligram(s)
- Max total dose
- 2184 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9260808 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 2184 mg milligram(s)
- Max treatment duration
- 24 Month(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
- No
PRD9260805 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 2184 mg milligram(s)
- Max treatment duration
- 24 Month(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
- No
PRD9260806 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 2184 mg milligram(s)
- Max treatment duration
- 24 Month(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
- No
PRD9260804 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 2184 mg milligram(s)
- Max treatment duration
- 24 Month(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
- No
PRD11001954 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 2184 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11001952 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 2184 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Dexamethason 8 mg GALEN® Tabletten
PRD808394 · Product
- Active substance
- Dexamethasone
- Substance synonyms
- DEXAMETASONE, DEXAMETHASONUM
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 4160 mg milligram(s)
- Max treatment duration
- 24 Month(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
- No
Dexamethasone Tablets BP 2.0mg
PRD3570594 · Product
- Active substance
- Dexamethasone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 4160 mg milligram(s)
- Max treatment duration
- 24 Month(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
- No
PRD10324900 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 4160 mg milligram(s)
- Max treatment duration
- 24 Month(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
- labelling and secondary packaging for clinical trial use
PRD10381752 · Product
- Active substance
- Talquetamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 800 µg/Kg microgram(s)/kilogram
- Max total dose
- 25600 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 24 Month(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
PRD10381753 · Product
- Active substance
- Talquetamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 800 µg/Kg microgram(s)/kilogram
- Max total dose
- 25600 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 24 Month(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
PRD9936206 · Product
- Active substance
- Teclistamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 3 mg/Kg milligram(s)/kilogram
- Max total dose
- 96 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9936207 · Product
- Active substance
- Teclistamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 3 mg/Kg milligram(s)/kilogram
- Max total dose
- 96 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Empliciti 400 mg powder for concentrate for solution for infusion.
PRD4073310 · Product
- Active substance
- Elotuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 640 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC23 — -
- Marketing authorisation
- EU/1/16/1088/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Empliciti 300 mg powder for concentrate for solution for infusion.
PRD4073295 · Product
- Active substance
- Elotuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 640 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC23 — -
- Marketing authorisation
- EU/1/16/1088/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
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
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
- IVIG is considered a modified AxMP because of the re-packaging/labelling activities that deviate from the approved drug product.
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
- IVIG is considered a modified AxMP because of the re-packaging/labelling activities that deviate from the approved drug product.
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
- CITIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CITIS Point of Contact
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| The Binding Site Group Limited ORG-100046643
|
Birmingham, United Kingdom | Laboratory analysis |
| Fisher Clinical Services GmbH ORG-100012942
|
Allschwil, Switzerland | Code 14 |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Cellcarta Biosciences Inc. ORG-100042227
|
Montreal, Canada | Laboratory analysis |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 8, Ireland | Other, Data management |
| IQVIA Laboratories LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Qd Solutions Inc. ORG-100041849
|
Austin, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
| Acolad Belgium ORG-100043515
|
Elsene, Belgium | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
Locations
13 EU/EEA countries · 74 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 10 | 2 |
| Belgium | Ongoing, recruitment ended | 16 | 4 |
| Czechia | Ongoing, recruitment ended | 22 | 4 |
| Denmark | Ongoing, recruitment ended | 15 | 2 |
| France | Ongoing, recruitment ended | 90 | 8 |
| Germany | Ongoing, recruitment ended | 10 | 4 |
| Greece | Ongoing, recruitment ended | 34 | 3 |
| Hungary | Ongoing, recruitment ended | 35 | 6 |
| Italy | Ongoing, recruitment ended | 80 | 13 |
| Netherlands | Ongoing, recruitment ended | 23 | 5 |
| Poland | Ongoing, recruitment ended | 50 | 6 |
| Spain | Ongoing, recruitment ended | 65 | 14 |
| Sweden | Ongoing, recruitment ended | 20 | 3 |
| Rest of world
United States, Saudi Arabia, Brazil, Canada, Mexico, India, United Kingdom, Turkey, Israel, Japan, Australia, China, Argentina, Korea, Democratic People's Republic of
|
— | 462 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
Universitätsklinik für Innere Medizin III, Muellner Hauptstrasse 48, 5020, Salzburg
Stadt Wien Wiener Gesundheitsverbund
1. Medizinische Abteilung – Zentrum für Onkologie und Hämatologie mit Ambulanz und Palliativstation, Montleartstrasse 37, Ottakring, Vienna
Grand Hopital De Charleroi
Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Vitaz
Hematology, Moerlandstraat 1, 9100, Sint-Niklaas
Universitair Ziekenhuis Gent
hematolgoy, Corneel Heymanslaan 10, 9000, Gent
Ziekenhuis Oost Limburg
Hematology, Synaps Park 1, 3600, Genk
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika (Department of Internal Hematology and Oncology), Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Hradec Kralove
IV. interni hematologicka klinika (The 4th Department of Internal Medicine – Hematology), Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Ostrava
Klinika hematoonkologie FNO a LF OU, 17. Listopadu 1790/5, 708 00, Poruba
University Hospital Olomouc
Hematoonkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Odense University Hospital
Klovervaenget 10, 12 sal Indgang 112, Haematologisk Forskningsenhed HFE-X, J B Winsloews Vej 4, 5000, Odense C
Aarhus Universitetshospital
Blodsygdomme Klinisk Forskningsenhed, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology Department, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Assistance Publique Hopitaux De Paris
Immuno-Hematology Service, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Paoli-Calmettes
Hematology department, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Nantes
Hematology Department, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
Blood diseases service, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Bordeaux
Hematology Department, Avenue De Magellan, 33600, Pessac
Hospices Civils De Lyon
Hematology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Regional Universitaire De Tours
Hematology and cell therapy, 2 Boulevard Tonnelle, 37000, Tours
Martin-Luther-Universitaet Halle-Wittenberg
Abt. Haematologie/Onkologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Augsburg
Comprehensive Cancer Center Augsburg - CCCA, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Heidelberg AöR
Abt. f. Innere Medizin 5; Schwerpunkt fuer Onkologie/ Haematologie/ Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Tuebingen AöR
Abt. f. Innere Medizin II Haematologie/Onkologie/Rheumatologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
General Hospital Of Athens Alexandra
Department of Clinical Therapeutics, Vassilissis Sofias Avenue 80, 115 28, Athens
Theageneio Cancer Hospital
Hematology Oncology Department, Papanastassiou Alexandrou 11, 546 39, Thessaloniki
251 Air Force General Hospital
Hematology Clinic, Kanellopoulou Avenue 3, 115 25, Athens
University Of Debrecen
N/A, Nagyerdei Korut 98, 4032, Debrecen
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
N/A, Albert Florian Ut 5-7, 1097, Budapest IX
University Of Pecs
N/A, Ifjusag Utja 13, 7624, Pecs
Semmelweis University
Belgyógyászati es Hematológiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
University Of Szeged
Belgyógyászat, Semmelweis Utca 8, 6725, Szeged
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
N/A, Szent Istvan Utca 68, 4400, Nyiregyhaza
Azienda Sanitaria Locale Br
U.O.C. Ematologia - P.O. "A. Perrino, Via Napoli 8, 72100, Brindisi
Azienda Ospedaliera Universitaria Integrata Verona
Ospedale Borgo Roma - Policlinico G.B. Rossi - UOC di Ematologia e Centro Trapianto di Midollo Osseo, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Ospedale San Raffaele S.r.l.
Onco-Ematologia U.O. Ematologia e TMO, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UOC Ematologia, Via Francesco Sforza 28, 20122, Milan
IRCCS Ospedale Policlinico San Martino
U.O. Clinica Ematologica, Largo Rosanna Benzi 10, 16132, Genoa
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 Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
S.C.D.U. Ematologia, Via Venezia 16, 15121, Alexandria
Ospedale Garibaldi
Presidio Ospedaliero Garibaldi-Nesima, Piazza Santa Maria Di Gesu, 95123, Catania
Azienda Unita Sanitaria Locale Della Romagna
Ospedale Santa Maria delle Croci, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione IRCCS Policlinico San Matteo
Ematologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Socio Sanitaria Territoriale Ovest Milanese
Ospedale di Legnano, Via Papa Giovanni Paolo II, 20025, Legnano
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
SSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Corso Bramante 88, 10126, Turin
Azienda Sanitaria Locale Di Pescara
P.O. Santo Spirito-UOC Ematologia-Dipartimento Oncologico Ematologico, Via Renato Paolini 47, 65124, Pescara
Haga Hospital
Hematology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Catharina Ziekenhuis Stichting
Catherina Cancer Institute, Michelangelolaan 2, 5623 EJ, Eindhoven
Flevoziekenhuis Stichting
Hematology, Hospitaalweg 1, 1315 RA, Almere
Isala Klinieken Stichting
Hematology, Dokter Van Heesweg 2, 8025 AB, Zwolle
St. Antonius Ziekenhuis
Hematology, Koekoekslaan 1, 3435 CM, Nieuwegein
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddzial Hematologii i Transplantacji Szpiku z Bankiem Tkanek i Komorek, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Oddział Hematologii, Ul. Terebelska 57/65, 21-500, Biala Podlaska
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
Klinika Hematologii z Oddziałem Transplantacji Szpiku, Ul. Unii Lubelskiej 1, 71-252, Szczecin
University Hospital Son Espases
Hematology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario De Burgos
Hematology, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Universitario Lucus Augusti
Hematology, Rua Dr. Ulises Romero 1, 27003, Lugo
Complexo Hospitalario Universitario De Santiago
Hematology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario De Navarra
Hematology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario La Paz
Hematology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Donostia
Hematology, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Virgen De Las Nieves
Hematology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario De Cabuenes
Hematology, Calle Prados 395, Cabuenes, Gijon
Uppsala University Hospital
KFUE Blod- och Tumorsjukdomar, Ing 100, 1 tr, Akademiska Sjukhuset, 751 85, Uppsala
Region Vaesterbotten
Klinisk Forskningsenhet Qa41 Cancercentrum, Koksvagen 11, Alidhem, Umea
Region Skane Skanes Universitetssjukhus
Hematologimottagningen, Klinisk forskningsmottagning, Entregatan 7, 222 42, Lund
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-07-01 | 2024-07-01 | 2025-09-12 | ||
| Belgium | 2024-02-26 | 2024-02-26 | 2025-09-12 | ||
| Czechia | 2024-04-12 | 2024-04-12 | 2025-09-12 | ||
| Denmark | 2024-07-10 | 2024-07-10 | 2025-09-12 | ||
| France | 2024-04-15 | 2024-04-15 | 2025-09-12 | ||
| Germany | 2024-08-01 | 2024-08-01 | 2025-09-12 | ||
| Greece | 2024-05-20 | 2024-05-20 | 2025-09-12 | ||
| Hungary | 2024-07-02 | 2024-07-02 | 2025-09-12 | ||
| Italy | 2024-03-15 | 2024-03-15 | 2025-09-12 | ||
| Netherlands | 2024-03-21 | 2024-03-21 | 2025-09-12 | ||
| Poland | 2024-03-01 | 2024-03-01 | 2025-09-12 | ||
| Spain | 2024-03-15 | 2024-03-15 | 2025-09-12 | ||
| Sweden | 2024-04-25 | 2024-04-25 | 2025-09-12 |
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-63556
- Event date
- 2024-12-11
- Submission date
- 2024-12-17
- In response to
- OTHER
- Member states affected
- Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Spain, Sweden, Netherlands, 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 167 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_REDACTED Protocol Contact Info_2022-502446-27 | 1 |
| Protocol (for publication) | D1_REDACTED Protocol EN_2022-502446-27 | Am6 |
| Protocol (for publication) | D1_REDACTED Protocol GR Greek_2022-502446-27 | Am2 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey AT Ger | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey BE Dut | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey BE FrE | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey CZ Cze | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey DE Ger | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey EN | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey ES Spa | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey FR Fre | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey GR Gre | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey HU Hun | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey IT Ita | 1 |
| Protocol (for publication) | D4_REDACTED PF Epstein Taste survey SE Swe | 1 |
| Protocol (for publication) | D4_REDACTED PF EQ-5D-5L Placeholder EN | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q AT Ger | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q BE Dut | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q BE Fre 27-Nov-2019 VTMF-19704990_1 | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q CZ Cze | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q DE Ger | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q EN | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q ES Spa | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q FR Fre | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q GR Gre | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q HU Hun | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q IT Ita | 1 |
| Protocol (for publication) | D4_REDACTED PF MySIm-Q SE Swe | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma AT Ger | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma BE Dut | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma BE Fre | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma CZ Cze | 2 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma DE Ger | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma EN | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma ES Spa | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma FR Fre | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma GR Gre | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma HU Hun | 2 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma IT Ita | 1 |
| Protocol (for publication) | D4_REDACTED PF PGIS myeloma SE Swe | 1 |
| Protocol (for publication) | D4_REDACTED PF QLQ-C30 Placeholder EN | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _AT_EN_64407564MMY3009 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _DE_ENG_64407564MMY3009 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _FR_FR_64407564MMY3009 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _GR_EN_64407564MMY3009 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _PL_PL_2022-502446-27 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BE_en_64407564MMY3009 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_CZ_CZE_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DK_eng_64407564MMY3009 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_ES_EN_64407564MMY3009 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_HU_ENG_64407564MMY3009 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_IT_ENG_64407564MMY3009 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_NL_en_64407564MMY3009 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_SE_Swe_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material CZE04 INT-1 Infographic_CZ_CZE_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material CZE06 INT-1 Dr Pat Letter_CZ_CZE_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dr to PAtient letter_PL_PL_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Infographic_PL_PL_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_ Infographic_DK_dan_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Dr to patient letter_AT_GER_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Dr to patient letter_DE_GER_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Infographic_GR_EL_2022-502446-27 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Infographic_SE_swe_2022-502446-27 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_recruitment infographic_AT_GER_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Recruitment Infographic_DE_GER_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material-Dr to Patient Letter_BE_en_64407564MMY3009 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material-Dr to Patient Letter_BE_fr_64407564MMY3009 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material-Dr to Patient Letter_BE_nl_64407564MMY3009 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material-Dr to Patient letter_NL_nl_64407564MMY3009 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material-Infographic_BE_en_64407564MMY3009 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material-Infographic_BE_fr_64407564MMY3009 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material-Infographic_BE_nl_64407564MMY3009 | 1.1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material-Infographic_NL_nl_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_ICF Main _HU_HUN_64407564MMY3009 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_ICF_PP _HU_HUN_64407564MMY3009 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_ICF_Withdrawal_HU_HUN_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_ICF-Pregnant Partner_BE_en_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_ICF-Pregnant Partner_BE_fr_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_ICF-Pregnant Partner_BE_nl_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult v4_BE_ITA_2022-502446-27 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult v5_BE_ITA_2022-502446-27 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult_BE_Dut_2022-502446-27 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult_BE_Eng_2022-502446-27 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult_BE_Fre_2022-502446-27 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult_BE_Ita_2022-502446-27 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF CLINICAL_PL_PL_2022-502446-27 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main highlighted_CZ_CZE_64407564MMY3009 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_CZ_CZE_64407564MMY3009 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_DK_dan_2022-502446-27 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Compatible Research_DK_dan_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy ICF_PL_PL_2022-502446-27 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant partner_CZ_CZE_64407564MMY3009 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DK_DAN_2022-502446-27 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_GR_gre_2022-502446-27 | 2.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Family_IT_ITA_2022-502446-27 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language to ICF-CZ _CZ_CZE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal Consent Form_PL_PL_2022-502446-27 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_CZ_CZE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical ICF_IT_ITA_64407564MMY3009 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical Informed Consent Form_DE_GER_ 64407564MMY3009 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Genetic ICF_AT_DE_ 64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF contact data sheet_AT_EN_2022-502446-27 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main ICF_FR_FR_64407564MMY3009 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main ICF_SE_SWE_64407564MMY3009 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main Informed Consent Form_AT_DE_ 64407564MMY3009 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main Informed Consent Form_GR_EL_ 64407564MMY3009 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_NL_nl_64407564MMY3009 | 7.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Patient Travel Reimbursement_IT_ITA_2022-502446-27 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnancy Consent Form_DE_GER_64407564MMY3009 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnancy ICF_FR_FR_64407564MMY3009 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnancy ICF_IT_ITA_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant ICF_SE_SWE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner ICF_AT_DE_ 64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_NL_nl_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Privacy Appendix Clinical ICF_IT_ITA_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Privacy Appendix Pregnancy ICF_IT_ITA_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal Consent Form_DE_GER_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal ICF_AT_DE_ 64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal ICF_FR_FR_64407564MMY3009 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal ICF_GR_EL_ 64407564MMY3009 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_IT_ITA_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_and_ICF_ clinical_ES_ES_6407564MMY3009 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_and_ICF_ Pregnancy_ES_ES_6407564MMY3009 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_and_ICF_ Withdrawal_ES_ES_6407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Patient facing document Temperature Diary_CZ_CZE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Pomalidomide Janssen Global PPP for CT_CZ_CZE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Pomalidomide PPP Adult Brochure_CZ_CZE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Pomalidomide PPP Adult Female_CZ_CZE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Pomalidomide PPP Adult Male_CZ_CZE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_AT_DE_ 64407564MMY3009 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_en_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_fr_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_Ita_2022-502446-27 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_nl_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_CZE_64407564MMY3009 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DK_dan_2022-502446-27 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2022-502446-27 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FRE_2022-502446-27 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_GR_EL_ 64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_ 2022-502446-27 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_PL_2022-502446-27 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_SE_SWE_64407564MMY3009 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L3_Temperature Diary_AT_DE_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L3_Temperature Diary_FR_FR_64407564MMY3009 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L3_Temperature Diary_GR_EL_64407564MMY3009 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_REDACTED Product Info pomalidomide | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone 2 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone 8 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC empliciti | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC imnovid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC velcade | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _AT_GER_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _BE_DUT_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _CZ_CZE_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _SE_SWE_2022-502446-27 | AM6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_FRE_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_GER_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2022-502446-27 | AM6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FRE_2022-502446-27 | AM6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_GR_GRE_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_IT_ITA_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_DUT_2022-502446-27 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_POL_2022-502446-27 | Am6 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-06 | Netherlands | Acceptable 2024-02-12
|
2024-02-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-16 | Acceptable 2024-02-12
|
2024-02-16 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-02-21 | Netherlands | Acceptable 2024-02-12
|
2024-02-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-02-21 | Acceptable 2024-02-12
|
2024-02-21 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-02-29 | Acceptable 2024-02-12
|
2024-02-29 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-02-29 | Acceptable 2024-02-12
|
2024-02-29 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-23 | Netherlands | Acceptable 2024-07-25
|
2024-07-25 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-08-02 | Acceptable 2024-07-25
|
2024-08-02 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-21 | Netherlands | Acceptable 2024-11-22
|
2024-11-22 |
| 10 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-03 | Acceptable | 2025-01-09 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-18 | Netherlands | Acceptable 2025-05-13
|
2025-05-13 |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-30 | Acceptable | 2025-07-01 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-30 | Acceptable | 2025-06-05 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-03 | Acceptable | 2025-08-13 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-03 | Acceptable | 2025-07-09 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-23 | Netherlands | Acceptable 2025-12-23
|
2025-12-24 |
| 17 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-02-17 | Netherlands | Acceptable 2026-04-17
|
2026-04-19 |