Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
806
Countries
9
Sites
45
Multiple Myeloma
To compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy in terms of PFS and sustained MRD-negative CR
Key facts
- Sponsor
- European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 May 2024 → ongoing
- Decision date (initial)
- 2024-05-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Janssen-Cilag International NV
External identifiers
- EU CT number
- 2023-507632-20-00
- EudraCT number
- 2021-003284-10
- ClinicalTrials.gov
- NCT05257083
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy, Pharmacodynamic
To compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy in terms of PFS and sustained MRD-negative CR
Secondary objectives 5
- To further compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy
- To characterize the safety of cilta-cel after DVRd therapy followed by lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy
- To characterize the PK and pharmacodynamics of cilta-cel
- To evaluate the PRO associated with DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy
- To determine whether RCL is present in participants that receive ciltacel
Conditions and MedDRA coding
Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, 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-trial/transparency. As noted on this site, requests for access to the study data can 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
- 18 years of age or older
- Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
- Measurable disease, as assessed by central laboratory, at screening as defined by any of the following: 1) Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 2) Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
- ECOG performance status of grade 0 or 1
- Clinical laboratory values within prespecified range as listed in 5.1.1, page 55 of the protocol.
Exclusion criteria 7
- Prior treatment with CAR-T therapy directed at any target.
- Any prior BCMA target therapy.
- Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
- Received a strong cytochrome P450 (CYP)3A4 inducer within 5 halflives prior to randomization
- Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
- Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
- Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- PFS
- Sustained MRD-negative CR, defined as MRD-negative CR for at a minimum 12 months duration, with MRD status determined by NGS with a sensitivity of at least 10-5
Secondary endpoints 11
- Overall response (PR or better) status and CR or better status
- Overall MRD-negative CR with a sensitivity of at least 10-5
- Time to subsequent antimyeloma therapy
- PFS on next-line therapy (PFS2)
- Incidence, severity, and type of AEs, clinical laboratory results, and other safety parameters
- OS
- PK and pharmacodynamic markers by protein, DNA, or RNA analyses, including but not limited to, systemic inflammatory cytokine concentrations, markers of CAR-T cell expansion (proliferation) and persistence via monitoring of cilta-cel-positive cellular concentrations, and cilta-cel transgene levels
- Mean change from baseline in the EORTC-QLQ-C30, MySIm-Q, and EQ-5D-5L subscale scores and the PROCTCAE items
- Time to improvement or worsening of symptoms, functioning, and overall well-being
- Improvement or worsening in the EORTC-QLQ- C30 and MySIm-Q subscale scores using the PGIS to calculate the meaningful change threshold
- Presence of RCL
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
Lenalidomide Accord 2.5 mg hard capsules
PRD6773391 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/001
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 25 mg hard capsules
PRD6773401 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/011
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 5 mg hard capsules
PRD6773393 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/003
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 20 mg hard capsules
PRD6773400 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/010
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 15 mg hard capsules
PRD6773398 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/008
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CARVYKTI 3.2 × 10^6 – 1.0 × 10^8 cells dispersion for infusion
PRD9718535 · Product
- Active substance
- Ciltacabtagene Autoleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XL05 — -
- Marketing authorisation
- EU/1/22/1648/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2252
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical trial will be conducted with "clinical" material. Compared to the authorized product, the same lentivector is used, as well as the same CAR-T manufacturing process. The only difference is that the lentivirus vector manufacturing process may differ from the authorized product, e.g. the adherent process instead of the suspension process.
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
- 1.3 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 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
PRD4219381 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PA 1691/014/001
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethason Teva 4 mg, tabletten
PRD626962 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- RVG 29754
- MA holder
- TEVA NEDERLAND B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(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
- specific labelling and packaging for the clinical trial by Clinigen Clinical Supplies Management SA, Watson & Crick Hill Rue Granbopré, 11 1435 Mont-Saint-Guibert, Belgium
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
European Myeloma Network B.V.
- Sponsor organisation
- European Myeloma Network B.V.
- Address
- Blaak 555
- City
- Rotterdam
- Postcode
- 3011 GB
- Country
- Netherlands
Scientific contact point
- Organisation
- European Myeloma Network Stichting
- Contact name
- Pieter Sonneveld
Public contact point
- Organisation
- European Myeloma Network Stichting
- Contact name
- Pieter Sonneveld
Third parties 23
| Organisation | City, country | Duties |
|---|---|---|
| Charles River Laboratories International Inc. ORG-100041066
|
Mattawan, United States | Other |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Other |
| Eurofins Pharma Bioanalytics Services US Inc. ORG-100049364
|
Saint Charles, United States | Laboratory analysis |
| Smithers PDS LLC ORG-100040403
|
Gaithersburg, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 12, Data management, E-data capture, Code 8 |
| Amsterdam UMC Stichting ORG-100008355
|
Amsterdam, Netherlands | Other, Laboratory analysis |
| Cerba Research ORG-100042694
|
Gent, Belgium | Other |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Nea Filadelfia, Greece | On site monitoring, Code 12 |
| Ospedale San Raffaele S.r.l. ORG-100006123
|
Milan, Italy | Other, Laboratory analysis |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) ORG-100008976
|
Rotterdam, Netherlands | Other, Laboratory analysis |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Other |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Clinigen Clinical Supplies Management ORG-100034422
|
Mont-Saint-Guibert, Belgium | Code 14, Laboratory analysis |
| Julius-Maximilians-Universitaet Wuerzburg ORG-100028645
|
Wuerzburg, Germany | Other, Laboratory analysis |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Other |
| Universita' Degli Studi Di Torino ORG-100008619
|
Turin, Italy | Other, Laboratory analysis |
| Phenopath Laboratories PLLC ORG-100051012
|
Seattle, United States | Other |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Other |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| Complexo Hospitalario Universitario De Santiago ORG-100041171
|
Santiago De Compostela, Spain | Other, Laboratory analysis |
Emn Trial Office S.r.l. Impresa Sociale
- Sponsor organisation
- Emn Trial Office S.r.l. Impresa Sociale
- Address
- Via Saluzzo 1/a, TO
- City
- Turin
- Postcode
- 10125
- Country
- Italy
Sponsor responsibilities
- Article 77 compliance
- European Myeloma Network B.V.
- Contact point sponsor
- European Myeloma Network B.V.
- Article 77 implementation
- European Myeloma Network B.V.
Locations
9 EU/EEA countries · 45 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 40 | 4 |
| Czechia | Ongoing, recruiting | 41 | 5 |
| France | Ongoing, recruiting | 29 | 7 |
| Germany | Ongoing, recruiting | 51 | 6 |
| Greece | Ongoing, recruiting | 23 | 2 |
| Netherlands | Ongoing, recruiting | 81 | 5 |
| Norway | Ongoing, recruiting | 18 | 1 |
| Spain | Ongoing, recruiting | 141 | 11 |
| Sweden | Ongoing, recruiting | 16 | 4 |
| Rest of world
Switzerland, Australia, Canada, United States, Israel, United Kingdom, Japan
|
— | 366 | — |
Investigational sites
Institut Jules Bordet
Oncologie Médicale, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Leuven
Z97BE10003;Hematology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Z97BE10001;Hematology, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Z97BE10004;Hematology, Corneel Heymanslaan 10, 9000, Gent
Fakultni Nemocnice Hradec Kralove
Z97CZ10003: IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Plzen
Z97CZ10005: Hematologicko-onkologicke odd., Alej Svobody 923/80, 323 00, Plzen 23
Vseobecna Fakultni Nemocnice V Praze
Z97CZ10004: I. Interni klinika - klinika hematologie VFN a 1. LF UK v Praze, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Brno
Z97CZ10002: Int. hemat. a onkol. klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
Z97CZ10001: Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Institut Universitaire Du Cancer Toulouse-Oncopole
Z97FR10004: Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Lyon Sud
Z97FR10005: Service d'Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Nantes
Z97FR10003: Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
Z97FR10002: Service des Maladies du Sang, 1 Place De Verdun, 59000, Lille
Hopital Saint Louis
Z97FR10001: Immunologie-Hematologie Clinique, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Poitiers
Z97FR10006: Service d’Hématologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Saint Antoine
Z97FR10007: Service d'Hématologie Clinique et Thérapie Cellulaire, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Universitaetsklinikum Leipzig AöR
Z97DE10006: University Cancer Center Dpt., Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsklinikum Tuebingen AöR
Z97DE10001: Onkologie, Hämatologie, Klinische Immunologie, Rheumatologie und Pulmologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
University Hospital Cologne AöR
Z97DE10004: Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
University Medical Center Hamburg-Eppendorf
Z97DE10007: Innere Medizin, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Wuerzburg AöR
Z97DE10002:Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Heidelberg AöR
Z97DE10003: Abteilung Innere Medizin V, Haematologie, Onkologie, Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Geniko Nosokomeio Thessalonikis George Papanikolaou
Z97GR10001:Hematology and HCT unit, Exochi, 570 10, Thessaloniki
Alexandra Hospital
Z97GR10002:Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Universitair Medisch Centrum Utrecht
Z97NL10003: Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Radboud universitair medisch centrum / RADBOUDUMC
Z97NL10002: Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Groningen
Z97NL10004: Hematology, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Z97NL10001: Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amsterdam UMC Stichting
Z97NL10005: Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Oslo University Hospital HF
Z97NO10001: Avdeling for blodsykdommer, Taarnbygget, Kirkeveien 166, Oslo
Complexo Hospitalario Universitario De Santiago
Z97ES10004: Hematología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital General Universitario Gregorio Maranon
Z97ES10003: Hematologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinic De Barcelona
Z97ES10002: Hematología, Calle Villarroel 170, 08036, Barcelona
Clinica Universidad De Navarra
Z97ES10010: Hematología, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario De Salamanca
Z97ES10007: Hematología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Ramon Y Cajal
Z97ES10005: Hematología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Institut Catala D'oncologia
Z97ES10008: Hematología, Carretera Canyet S/n, 08916, Badalona
Institut Catala D'oncologia
Z97ES10011: Hematologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Z97ES10006: Hematología y Hemoterápia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Y Politecnico La Fe
Z97ES10001: Hematología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Hospital Virgen Del Rocio S.L.
Z97ES10009: Hematologia y Hemoterapia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Uppsala University Hospital
Z97SE10004:Oncology, Akademiska Sjukhuset, 751 85, Uppsala
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Z97SE10002:Sektionen för Hematologi och K, Bla Straket 5, 413 46, Goteborg
University Of Skane
Z97SE10001:Outpatient department, Jan Waldenstroms Gata 15, Malmo St Johannes, Malmo
Linkoping University Hospital Region Ostergotland
Z97SE10003:Hematologiska Kliniken, Universitetssjukhuset I Linkoping, 581 85, Linkoping
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 | 2024-06-28 | 2024-06-28 | |||
| Czechia | 2024-06-28 | 2024-06-28 | |||
| France | 2024-06-28 | 2024-06-28 | |||
| Germany | 2024-06-28 | 2024-06-28 | |||
| Greece | 2024-06-28 | 2024-06-28 | |||
| Netherlands | 2024-05-01 | 2024-06-28 | |||
| Norway | 2024-06-28 | 2024-06-28 | |||
| Spain | 2024-06-28 | 2024-06-28 | |||
| Sweden | 2024-06-28 | 2024-06-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-92977
- Event date
- 2025-07-28
- Date aware
- 2025-07-28
- Submission date
- 2025-08-04
- Member states affected
- Spain, Norway, Czechia, Belgium, France, Germany, Greece, Sweden, Netherlands
- Clinical procedures
- Exceptional release for JNJ-68284528 Drug Product (DP) - Dosing
Administration - Event description
- Medical product:PRD9718535
Active substance:SUB199371
Out of Specification administration: Manufacturing of JNJ-68284528 DP
for Subject Z97FR10002008 (Batch PLGS09P ) was performed at the
Janssen DP manufacturing facility in Ghent Obelisc, Belgium. An out of
specification (OOS) result: OOS IFNγ Secretion Potency Assay result: 1586
pg/mL
Specifications IFNγ Secretion Potency Assay: 2616-85000pg/mL All other drug product quality attributes met the specification.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 159 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Main 2023-507632-20-00 Public | 8.0 |
| Protocol (for publication) | D1_Protocol Main 2023-507632-20-00 Public | 8.0 |
| Protocol (for publication) | D4_Patient facing information BEL Dutch EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information BEL Dutch EQ-5D-5L EMN2868284528MMY3005 Public | 1.2 |
| Protocol (for publication) | D4_Patient facing information BEL Dutch MySlm-Q EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information BEL Dutch PGIS EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information BEL EQ-5D-5L EMN2868284528MMY3005 Public | 1.1 |
| Protocol (for publication) | D4_Patient facing information BEL FRA QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information BEL Myslm-Q EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information BEL PGIS FRA EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information BEL PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information BEL QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information CZE Handwriting EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information CZE MySlm-Q EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information CZE PGISCZE EMN2868284528MMY3005 Public | 2.0 |
| Protocol (for publication) | D4_Patient facing information CZE PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information CZE QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information DEU 7QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information DEU EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information DEU EQ-5D-5L EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information ESP Multiple Myeloma EMN2868284528MMY3005 Public | 2.0 |
| Protocol (for publication) | D4_Patient facing information ESP MySlm-Q_ESP EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information ESP PRO EQ-5D-5L EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information ESP QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information FRA EQ-5D-5L EMN2868284528MMY3005 Public | 1.2 |
| Protocol (for publication) | D4_Patient facing information FRA Handwriting assessment EMN2868284528MMY3005 Public | 2.0 |
| Protocol (for publication) | D4_Patient facing information FRA MySlm-Q EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information FRA PGIS_MM EMN2868284528MMY3005 Public | 2.0 |
| Protocol (for publication) | D4_Patient facing information FRA PRO EQ-5D-5L EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information FRA PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information FRA QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information FRA Questionnaire filling guide EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information GRC EQ-5D-5L EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information GRC MySlm-Q_GR EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information GRC QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information GRE PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information NLD 5D-5L EMN2868284528MMY3005 Public | 1.1 |
| Protocol (for publication) | D4_Patient facing information NLD Dutch PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information NLD PGIS MM EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information NLD QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information NOR CART-6 EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information NOR CARTITUDE Handwriting log | 1.0 |
| Protocol (for publication) | D4_Patient facing information NOR EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information NOR EQ-5D-5L EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information NOR Multiple Myeloma EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information NOR MySIm-Q_NO-nor EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information NOR QLQ-C30 EMN2868284528MMY3005 Public | 2.0 |
| Protocol (for publication) | D4_Patient facing information PGIS EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information PGIS MM EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information QLQ-C30 EMN2868284528MMY3005 Public | 3.0 |
| Protocol (for publication) | D4_Patient facing information SWE EQ-5D-5L EMN2868284528MMY3005 Public | 1.1 |
| Protocol (for publication) | D4_Patient facing information SWE Handwriting EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information SWE MySlm-Q EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information SWE PGIS MM EMN2868284528MMY3005 Public | 2.0 |
| Protocol (for publication) | D4_Patient facing information SWE PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing information SWE QLQ-C30 EMN2868284528MMY3005 Public | 2.1 |
| Protocol (for publication) | D4_Patient facing informationBEL Dutch PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing informationBEL FRA EQ-5D-5L EMN2868284528MMY3005 Public | 1.0 |
| Protocol (for publication) | D4_Patient facing informationBEL-FRA PRO-CTCAE EMN2868284528MMY3005 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangement filenote EMN2868284528MMY3005 | NA |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements Filenote EMN2868284528MMY3005 | NA |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements filenote EMN2868284528MMY3005 | NA |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements Filenote EMN2868284528MMY3005 | NA |
| Recruitment arrangements (for publication) | K1_Recruitement Procedure Description EMN2868284528MMY3005 Public | V 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements File note EMN2868284528MMY3005 | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Filenote EMN2868284528MMY3005 | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Filenote EMN2868284528MMY3005 | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Filenote_EMN2868284528MMY3005 | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure Description and ICF Procedure EMN2868284528MMY | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure Description EMN 2868284528MMY3005 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure Description EMN2868284528MMY3005 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure Description EMN2868284528MMY3005 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure Description EMN2868284528MMY3005 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure Description EMN2868284528MMY3005 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure Description EMN2868284528MMY3005 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ ICF - Sub-study 1 English Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ ICF Main Adult Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_ ICF Main Adult Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_ ICF Main Public | 7 |
| Subject information and informed consent form (for publication) | L1_ ICF Main Public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF Sub Study Adult Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ ICF Sub Study French Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ ICF Sub Study Public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF Sub Study TC | 5.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Research Adult already enrolled Czech Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Sub Study Adult Spanish Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Adult English Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Form English Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Form English Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Research Adult English Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Sub-study Adult Correlative English Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Sub-study English 2 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Data Protection Adult_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Data Protection already enrolled Czech Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research Adult EMN2868284528MMY3005 Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main 3 English Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult already enrolled Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult English Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Appendix Swedish EMN28-68284528MMY3005 Public | 6.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main Dutch Public | 6.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main English 1 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main English 2 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main English Public | 6.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main French Public | 6.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main ICF Appendix 1 Norwegian Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Swedish EMN28-68284528MMY3005 Public | 6.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Z97GR10002 English Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Z97GR10002 Greek Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other Adult Pregnancy Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Other EMN2868284528MMY3005 Public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Procedure EMN 2868284528MMY3005 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF procedure EMN28-68284528MMY3005 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Procedure EMN2868284528MMY3005 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Procedure EMN2868284528MMY3005 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Procedure Public | V1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Research Adult Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Research Adult_EMN2868284528MMY3005_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Research EMN2868284528MMY3005 Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF Sub Study Adult Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_ICF Sub Study Adult Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Sub Study adult_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Sub Study already enrolled Czech Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Sub Study Dutch Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Sub Study English Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Sub Study Public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Sub Study Public EMN28-68284528MMY3005 | 5.1 |
| Subject information and informed consent form (for publication) | L1_IRB-IEC Approval Greek EMN2868284528MMY3005 | NA |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Main Adult Norwegian Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_Subject Participation Card Arm AEMN2868284528MMY3005 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_Subject Participation Card Arm B Public | 5.0 |
| Subject information and informed consent form (for publication) | L2_ ESP Country ICF Other Pregnant Partner Spanish Public | 4.0 |
| Subject information and informed consent form (for publication) | L2_ ICF Other PP EMN2868284528MMY3005 Public | 4.0 |
| Subject information and informed consent form (for publication) | L2_ ICF Other PP EMN2868284528MMY3005 Public | 4.0 |
| Subject information and informed consent form (for publication) | L2_ICF Other EMN2868284528MMY3005 Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_ICF Other PP | 4.0 |
| Subject information and informed consent form (for publication) | L2_ICF Other PP EMN2868284528MMY3005 Public | 3.1 |
| Subject information and informed consent form (for publication) | L2_ICF Other Pregnant Partner Dutch EMN2868284528MMY3005 Public | 4.1 |
| Subject information and informed consent form (for publication) | L2_ICF Other Pregnant Partner English EMN2868284528MMY3005 Public | 4.1 |
| Subject information and informed consent form (for publication) | L2_ICF Other Pregnant Partner French EMN2868284528MMY3005 Public | 4.1 |
| Subject information and informed consent form (for publication) | L2_ICF Other Pregnant Partner_Czech Public | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC DARZALEX EMN2868284528MMY3005 Public | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 CZE Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 DEU BEL Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 DEU Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 Dutch BEL Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 ENG Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 ESP Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 FRA BEL Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 FRA Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 NLD Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 NOR Main Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 NOR Public | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Main 2023-507632-20-00 SWE Public | 8.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-28 | Netherlands | Acceptable 2024-05-01
|
2024-05-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-22 | Netherlands | Acceptable 2024-10-09
|
2024-10-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-15 | Acceptable 2024-10-09
|
2024-11-15 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-22 | Netherlands | Acceptable 2024-12-13
|
2024-12-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-14 | Netherlands | Acceptable 2025-03-17
|
2025-03-18 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-02 | Netherlands | Acceptable 2025-10-06
|
2025-10-06 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-03 | Acceptable 2025-10-06
|
2025-11-03 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-04 | Acceptable 2025-10-06
|
2025-11-04 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-04 | Acceptable | 2026-01-13 |