Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
863
Countries
9
Sites
60
Relapsed or Refractory Multiple Myeloma
To compare the efficacy of Tal-DP and Tal-D, respectively, with DPd
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
- 12 Oct 2022 → ongoing
- Decision date (initial)
- 2024-07-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503467-41-00
- EudraCT number
- 2021-000202-22
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic, Therapy, Efficacy, Others, Pharmacokinetic
To compare the efficacy of Tal-DP and Tal-D, respectively, with DPd
Conditions and MedDRA coding
Relapsed or Refractory Multiple 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
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, request 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
- Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
- Documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
Exclusion criteria 6
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
- Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
- Received prior pomalidomide therapy
- A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-Free Survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
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
- 68470 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 172 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
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
- 68470 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 172 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
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
- 3612 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled/re-packaged (secondary) for the intent of the clinical trial
PRD11001952 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 3612 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11001954 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 3612 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11001955 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 3612 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- 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
- 3612 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled/re-packaged (secondary) for the intent of the clinical trial
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
- 3612 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled/re-packaged (secondary) for the intent of the clinical trial
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
- 3612 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled/re-packaged (secondary) for the intent of the clinical trial
PRD11001953 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 3612 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 6880 mg milligram(s)
- Max treatment duration
- 172 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
- re-labeled/re-packaged (secondary) for the intent of the clinical trial
PRD10324900 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 6880 mg milligram(s)
- Max treatment duration
- 172 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
- re-labeled/re-packaged (secondary) for the intent of the clinical trial
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
- 6880 mg milligram(s)
- Max treatment duration
- 172 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
- re-labeled/re-packaged (secondary) for the intent of the clinical trial
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 95400 mg milligram(s)
- Max treatment duration
- 172 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
- re-labeled/re-packaged (secondary) for the intent of the clinical trial
Auxiliary 6
KIOVIG 100 mg/ml solution for infusion
PRD7734931 · 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/1/05/329/003
- MA holder
- TAKEDA MANUFACTURING AUSTRIA AG
- 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.
KIOVIG 100 mg/ml solution for infusion
PRD7734927 · 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/1/05/329/004
- MA holder
- TAKEDA MANUFACTURING AUSTRIA AG
- 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
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
- 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
- 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
PRD339232 · 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/1/08/446/003
- 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.
KIOVIG 100 mg/ml solution for infusion
PRD7734926 · 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/1/05/329/005
- MA holder
- TAKEDA MANUFACTURING AUSTRIA AG
- 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
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| SGS Belgium ORG-100007917
|
Antwerp, Belgium | Code 10 |
| Hematogenix ORG-100047219
|
Cyberjaya, Malaysia | Laboratory analysis |
| Almac Clinical Services LLC ORG-100041692
|
Souderton, United States | Interactive response technologies (IRT) |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Parexel China Co. Ltd. ORG-100043174
|
Shanghai, China | Data management |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
9 EU/EEA countries · 60 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 16 | 5 |
| Czechia | Ongoing, recruitment ended | 36 | 4 |
| France | Ongoing, recruitment ended | 23 | 7 |
| Germany | Ongoing, recruitment ended | 14 | 4 |
| Greece | Ongoing, recruitment ended | 6 | 2 |
| Italy | Ongoing, recruitment ended | 63 | 13 |
| Netherlands | Ongoing, recruitment ended | 10 | 3 |
| Poland | Ongoing, recruitment ended | 79 | 9 |
| Spain | Ongoing, recruitment ended | 63 | 13 |
| Rest of world
United Kingdom, China, Brazil, Taiwan, Japan, Korea, Republic of, Turkey, Israel, United States
|
— | 553 | — |
Investigational sites
Jessa Ziekenhuis
Hematologie, Stadsomvaart 11, 3500, Hasselt
UZ Brussel
Hematologie, Laarbeeklaan 101, 1090, Jette
Antwerp University Hospital
Hematologie, Drie Eikenstraat 655, 2650, Edegem
Clinique Saint-Pierre
Oncologie - Hématologie, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
CHC MontLegia
Hémato-oncologie, Boulev. De Patience Et Beajonc 2, 4000, Liege
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika - klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Kralovske Vinohrady
Interni hematologicka klinika, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Hradec Kralove
IV. Interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Centre Leon Berard
Onco-Hematology Department, 28 Rue Laennec, 69008, Lyon
Hopital Saint Antoine
Hematology Department, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Universitaire De Nantes
Clinical Hematology Department, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Clinical Hematology Department, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre Hospitalier Universitaire De Montpellier
Department of Clinical Hematology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Bordeaux
Clinical Hematology Department, Avenue De Magellan, 33600, Pessac
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology Department, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Universitaet Leipzig
Medizinische Klinik und Poliklinik I - Bereich Haematologie und Zelltherapie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik und Poliklinik V, Hämatologie/Onkologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Asklepios Kliniken Hamburg GmbH
2. Medizin, Im Ambulanzzentrum 2/EG/R.508, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department - Bone Marrow Transplantation Unit, Exochi, 570 10, Thessaloniki
Alexandra Hospital
Therapeutic Clinic-Oncology Department of, General Hospital of Athens, Vassilissas Sofias Avenue 80, 115 28, Athens
Fondazione IRCCS Istituto Nazionale Dei Tumori
Dipartimento di Oncologia Medica ed Ematologia - S.C. di Ematologia, Via Giacomo Venezian 1, 20133, Milan
ASST Grande Ospedale Metropolitano Niguarda
SC Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Ematologia Con Trapianto di Midollo Osseo, Via Santa Sofia 78, 95123, Catania
Casa Sollievo Della Sofferenza
Unità Operativa di Ematologia, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche U.O. di Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Divisione di Ematologia, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera di Padova
U.O. Ematologia, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
U.O.C. di Oncoematologia, Via Trabucco 180, 90146, Palermo
Azienda Ospedaliero Universitaria Delle Marche
SOD Clinica Ematologica, Via Conca 71, 60126, Ancona
Fondazione IRCCS Policlinico San Matteo
UO di Ematologia, Viale Camillo Golgi 19, 27100, Pavia
University Hospital Consorziale Policlinico
Dipartimento di Scienze Biomediche e Oncologia Umana - UOC Medicina Interna e Oncoematologia, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Dipartimento di Oncologia Clinica - U.O. di Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda USL IRCCS Di Reggio Emilia
Ematologia, Viale Risorgimento 80, 42123, Reggio Emilia
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Albert Schweitzer Ziekenhuis
Hematologie, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Maxima Medisch Centrum
Hematologie, De Run 4600, 5504 DB, Veldhoven
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Oddział Hematologii, Ul. Sw. Jozefa 53/59, 87-100, Torun
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
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział hematologii Onkologicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Klinika Hematologii z Oddziałem Transplantacji Szpiku, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Clinica Universidad De Navarra
Servicio de Hematología, Avenue Pio XII 36, 31008, Pamplona
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
Servicio de Hematología, Calle De San Quintin 77-79, 08041, Barcelona
University Clinical Hospital Virgen De La Arrixaca
Servicio de Hematología, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitari Vall D Hebron
Servicio de Hematología, Edificio Materno-Infantil, Passeig De La Vall D'Hebron 119-129, Barcelona
Hospital Universitario De Leon
Servicio de Hematología, Calle Altos De Nava S/n, 24071, Leon
Hospital Universitario Virgen De La Victoria
Servicio de Hematología, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario 12 De Octubre
Servicio de Hematología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
Servicio de Hematología, Calle Villarroel 170, 08036, Barcelona
Hospital De Jerez De La Frontera
Servicio de Hematología, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Universitario De Canarias
Servicio de Hematología, Calle Ofra Sn La Cuesta, 38320, La Laguna
Hospital Universitario De Salamanca
Servicio de Hematología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Germans Trias I Pujol
Servicio de Hematología, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Dr Peset Aleixandre
Servicio de Hematología, Avinguda De Gaspar Aguilar 90, 46017, Valencia
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 |
|---|---|---|---|---|---|
| Belgium | 2022-10-28 | 2022-11-08 | 2024-03-20 | ||
| Czechia | 2022-11-25 | 2022-12-29 | 2024-01-17 | ||
| France | 2022-12-21 | 2022-12-21 | 2024-03-15 | ||
| Germany | 2023-03-17 | 2023-07-05 | 2024-03-07 | ||
| Greece | 2023-01-05 | 2023-08-18 | 2024-03-29 | ||
| Italy | 2022-11-17 | 2023-01-03 | 2024-04-11 | ||
| Netherlands | 2023-02-15 | 2023-03-14 | 2024-03-01 | ||
| Poland | 2022-10-12 | 2022-10-13 | 2024-02-15 | ||
| Spain | 2022-11-03 | 2022-11-07 | 2024-03-19 |
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-63547
- Event date
- 2024-12-11
- Submission date
- 2024-12-17
- In response to
- OTHER
- Member states affected
- Belgium, Czechia, France, Germany, Greece, Italy, Spain, 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 103 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_REDACTED Protocol 2023-503467-41 | Am5-EEA-5 |
| Protocol (for publication) | D1_REDACTED Protocol_GR_2023-503467-41 | Am3-EEA-4 |
| Protocol (for publication) | D4_REDACED PF EORTC QLQ-C30 | NA |
| Protocol (for publication) | D4_REDACTED PF EQ-5D-5L | NA |
| Protocol (for publication) | D4_REDACTED PF MySlm-Q | NA |
| Protocol (for publication) | D4_REDACTED PF NCI PRO CTCAE | NA |
| Protocol (for publication) | D4_REDACTED PF PGIS | NA |
| Protocol (for publication) | D4_REDACTED PF PROMIS PF 8c | NA |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_CZ_ENG_64407564MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_DE_EN_64407564MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_ES_EN_64407564MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment arrangements_GR_EN_64407564MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_IT_ENG_64407564MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_PL_EN_64407564MMY3002 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arrangements_FR_EN_64407564MMY3002 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_Placeholder_BE_en_64407564MMY3002 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_placeholder_NL_en_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_Addendum ICF_GR_GRE_64407564MMY3002 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_Main_ICF_GR_GRE_64407564MMY3002 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_Pregnant_Partner_ICF_GR_GRE_64407564 | 3.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2_BE_Dut_2023-503467-41 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2_BE_Fre_2023-503467-41 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2_NL_Dut_2023-503467-41 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 3_BE_Dut_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 3_BE_Fre_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF addendum 4_FR_fre_2023-503467-41 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_ES_SPA_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Appendix Privacy family_IT_ITA_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_ENG_2023-503467-41 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_SPA_2023-503467-41 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 3_NL_Dut_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum_BE_Dut_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum_BE_Fre_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum_NL_Dut_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_CZ_CZE_64407564MMY3002 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_Highlighted_CZ_CZE_64407564MMY3002 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_IT_ITA_64407564MMY3002 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_PL_PL_64407564MMY3002 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum 1_PL_POL_2023-503467-41 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum 2_PL_POL_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum 3_PL_POL_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum_ES_ES_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Patient Travel Reimbursement_IT_ITA_2023-503467-41 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_CZE_64407564MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_ENG_2023-503467-41 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_ES_64407564MMY3002 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_IT_ITA_64407564MMY3002 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PL_PL_64407564MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient_ES_ES_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Langualage_CZ_CZE_64407564MMY3002 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Samples Archiving_CZ_CZE_64407564MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_CZ_CZE_64407564MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_ENG_2023-503467-41 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_ES_64407564MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PL_PL_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_FR_fre_2023-503467-41 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_BE_en_64407564MMY3002 | 4.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_BE_fr_64407564MMY3002 | 4.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_BE_nl_64407564MMY3002 | 4.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_country Addendum ICF_DE_GER_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country Withdrawal ICF_DE_GER_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main Addendum_FR_FR_64407564MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main Country ICF_DE_GER_64407564MMY3002 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_FR_FR_64407564MMY3002 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_NL_nl_64407564MMY3002 | 4.4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnancy Partner_NL_nl_64407564MMY3002 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_FR_FR_64407564MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_FR_FR_64407564MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnancy Partner_BE_en_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnancy Partner_BE_fr_64407564MMY3002_v1_20Feb2024 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnancy Partner_BE_nl_64407564MMY3002_v1_20Feb2024 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICR_Pregnant Partner ICF_DE_GER_66407564MMY3002 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and Privacy Appendix_IT_ITA_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and Withdrawal ICF_GR_GRE_64407564MMY3002 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and Withdrawal_IT_ITA_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Global Pregnancy Prevention Plan_BE_Dut_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Global Pregnancy Prevention Plan_BE_Fre_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_en_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_fr_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_nl_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_CZE_64407564MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2023-503467-41 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FR_64407564MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_GR_GRE_64407564MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_64407564MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_PL_64407564MMY3002 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Product Information pomalidomide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC dexamethasone 2mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC dexamethasone 4mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC pomalidomide | 1 |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol Synopsis CZ 2023-503467-41 | Am5-EEA-5 |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol synopsis EN 2023-503467-41 | Am3-EEA-4 |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol synopsis ES 2023-503467-41 | Am5 EEA-5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis PL 2023-503467-41 | Am5-EEA5 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_FR_2023-503467-41 | AM5-EEA-5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis BE_de_2023-503467-41 | Am5 EEA5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis BE_fr_2023-503467-41 | Am5 EEA5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis BE_nl_2023-503467-41 | Am5 EEA5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis IT 2023-503467-41 | Am5-EEA5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis NL_nl_2023-503467-41 | Am5-EEA5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_GR_GRE_2023-503467-41 | AM5-EEA5 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | Netherlands | Acceptable with conditions 2024-06-28
|
2024-06-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-09 | Netherlands | Acceptable 2024-12-11
|
2024-12-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-22 | Netherlands | Acceptable 2025-03-24
|
2025-03-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-31 | Netherlands | Acceptable 2025-09-18
|
2025-09-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-18 | Netherlands | Acceptable 2026-01-20
|
2026-01-21 |