Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
182
Countries
9
Sites
37
Multiple Myeloma
The primary objective of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen R&D studies that use daratumumab as part of the study treatment regimen: access for all participants regardless …
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
- 28 Feb 2023 → ongoing
- Decision date (initial)
- 2023-10-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development LLC
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
The primary objective of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen R&D studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed, from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.
Conditions and MedDRA coding
Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Participants must: be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen R&D studies or receiving other study treatment in a Janssen R&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis, continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months.
- Investigator’s assessment that the benefit of continued study treatment will outweigh the risks.
- A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study
- A female participant must be either of the following: a. Not of childbearing potential, or b. Of childbearing potential and practicing at least 1 highly effective method of contraception throughout the study and through 3 months after the last dose of daratumumab.
- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study for specified periods after the last dose of study treatment.
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for specified periods after the last dose of study treatment. If partner is a female of childbearing potential, the male participant must use condom with spermicide and the partner must also be practicing a highly effective method of contraception. A male participant who is vasectomized must still use a condom (with or without spermicide), but the partner is not required to use contraception.
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment.
- Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- Willing and able to adhere to the lifestyle restrictions specified in this protocol.
Exclusion criteria 4
- Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment.
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab IB and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide).
- Vaccinated with an investigational vaccine (except for COVID-19) or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary endpoint is when no more patients require continued access to Daratumumab via this study, which means they have discontinued study treatment or have other alternative access to Daratumumab.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
DARZALEX 1800 mg solution for injection
PRD8157848 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 1800 mg/kg milligram(s)/kilogram
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD4091122 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 16 mg/kg milligram(s)/kilogram
- Max total dose
- 16 mg/kg milligram(s)/kilogram
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/002
- 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
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD4091129 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 16 mg/kg milligram(s)/kilogram
- Max total dose
- 16 mg/kg milligram(s)/kilogram
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/001
- 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
- No
Auxiliary 11
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 28 Day(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
- No
PRD9260814 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/008
- 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
PRD9260808 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4 mg milligram(s)
- Max treatment duration
- 28 Day(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
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kyprolis 60 mg powder for solution for infusion
PRD3374183 · Product
- Active substance
- Carfilzomib
- Substance synonyms
- PR-171
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 70 mg/m2 milligram(s)/sq. meter
- Max total dose
- 70 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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 3
| Organisation | City, country | Duties |
|---|---|---|
| 4G Clinical LLC ORQ-110020274
|
Wellesley, United States | Interactive response technologies (IRT) |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Other, Code 2, Code 5, Code 8 |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring, Other, Code 2, Code 8 |
Locations
9 EU/EEA countries · 37 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 3 | 2 |
| Czechia | Ongoing, recruitment ended | 6 | 3 |
| Denmark | Ended | 1 | 1 |
| France | Ongoing, recruitment ended | 8 | 5 |
| Germany | Ongoing, recruitment ended | 6 | 3 |
| Greece | Ongoing, recruitment ended | 6 | 2 |
| Italy | Ended | 3 | 3 |
| Poland | Ongoing, recruitment ended | 4 | 2 |
| Spain | Ongoing, recruitment ended | 42 | 16 |
| Rest of world
United States, China, Korea, Republic of
|
— | 103 | — |
Investigational sites
Ziekenhuis Aan De Stroom
ZAS Cadix, Kempenstraat 100, 2030, Antwerp
Ziekenhuis Aan De Stroom
ZAS Middelheim, Lindendreef 1, 2020, Antwerp
Fakultni Nemocnice Plzen
Department of Hematology and Oncology, Alej Svobody 923/80, 323 00, Plzen 23
Fakultni Nemocnice Brno
Department of Internal Medicine, Hematology and Oncolog, Jihlavska 340/20, Bohunice, Brno
Vseobecna Fakultni Nemocnice V Praze
Hematology Clinic, U Nemocnice 499/2, Nove Mesto, Prague
Region Midtjylland
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Universitaire De Caen Normandie
Clinical Hematology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Hopital Saint Louis
ImmunoHematology, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Regional Universitaire De Tours
Department of Hematology, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Nantes
Clinical Hematology, Faculty of Medicine, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Bordeaux
Department of Clinical Hematology and Cellular Therapy, Avenue De Magellan, 33600, Pessac
Universitaetsklinikum Tuebingen
Internal Medicine II Hematology, oncology, clinical immunology and rheumatology, Otfried-Mueller-Strasse 4/1, Nordstadt, Tuebingen
Asklepios Klinik Altona
II. Medical Department (Hematology, Medical Oncology and Infectious Disease), Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Klinikum Chemnitz gGmbH
Internal Medicine III - Hematology / Oncology / Stem Cell Transplantatio, Flemmingstrasse 4, Altendorf, Chemnitz
Theageneio Cancer Hospital
Hematology Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
Alexandra Hospital
Department of Clinical Therapeutics National & Kapodistrian University of Athens School of Medicine, Vassilissas Sofias Avenue 80, 115 28, Athens
Azienda Ospedaliero-Universitaria Policlinico Umberto I
U.O.C. Ematologia, Viale Del Policlinico 155, 00161, Rome
Fondazione IRCCS Policlinico San Matteo
U.O.C. Ematologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliera Policlinico Universitario Tor Vergata
U.O.C. Patologie Linfoproliferative, Viale Oxford 81, 00133, Rome
Wojewodzki Szpital Specjalistyczny W Legnicy
Oddział Hematologiczny, Ul. Jaroslawa Iwaszkiewicza 5, 59-220, Legnica
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
University Clinic Of Navarra
Hematology and hemotherapy, Avenida De Pio XII 36, 31008, Pamplona
Catalan Institute Of Oncology
Clinical research unit, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Hm Sanchinarro
Hematology, Calle Ona 10, 28050, Madrid
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58, 37007, Salamanca
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Of Canary Islands
Hematology, Carretera De La Cuesta Taco S/n, Cuesta La, San Cristobal De La Laguna
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
University Clinic Of Navarra
Hematology and hemotherapy, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Dr Peset Aleixandre
Hematology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Fundacio Assistencial De Mutua De Terrassa Fpc
Hematology, Calle De San Antonio No 32, 08221, Terrassa
Hospital Universitario Fundacion Alcorcon
Servicio de Hematología, Calle Budapest 1, 28922, Alcorcon
Hospital Universitario Quironsalud Madrid
Hematology and Hemotherapy, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Del Mar
Hematología, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
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 | 2024-03-06 | 2024-03-06 | 2024-03-08 | ||
| Czechia | 2025-10-27 | 2025-10-27 | 2026-01-23 | ||
| Denmark | 2024-02-22 | 2025-02-27 | 2024-03-07 | 2024-03-07 | |
| France | 2023-02-28 | 2023-02-28 | 2024-02-22 | ||
| Germany | 2023-03-16 | 2023-04-11 | 2023-08-08 | ||
| Greece | 2024-02-29 | 2024-02-29 | 2024-04-01 | ||
| Italy | 2024-07-25 | 2024-11-05 | 2024-07-25 | 2024-08-26 | |
| Poland | 2024-03-26 | 2024-04-02 | 2024-07-15 | ||
| Spain | 2023-03-15 | 2023-03-15 | 2024-06-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 58 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-500138-27-01_Greek_redacted | Amendment2 |
| Protocol (for publication) | D1_Protocol_2022-500138-27-01_redacted | Amendment2 |
| Protocol (for publication) | D1_Protocol_2022-500138-27-01_tc_Memo to File | 2 |
| Protocol (for publication) | Sup Doc_Validation RFI 7 response_Ini Appl | 1 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment Procedure | 3.0 |
| Recruitment arrangements (for publication) | K1_CZ_Recruitment Procedure_Billingual | 1.0 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment Procedure | 3.0 |
| Recruitment arrangements (for publication) | K1_DK_Recruitment Procedure | 3.0 |
| Recruitment arrangements (for publication) | K1_EL_Recruitment Procedure | 3.0 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Procedure | 3.0 |
| Recruitment arrangements (for publication) | K1_FR_Recruitment Procedure_Bilingual | 2.0 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment Procedure_Polish | 3.0 |
| Subject information and informed consent form (for publication) | DE_SIS_ICF_Pregnant Partner_German_TC | v3.0 |
| Subject information and informed consent form (for publication) | DE_SIS-ICF_Pregnant Partner_German | 1.1 |
| Subject information and informed consent form (for publication) | ES_SIS-ICF_Pregnant Partner_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | FR_SIS-ICF_Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF Procedure | 2.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_Dutch_redacted | 8.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_French_redacted | 8.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy_Dutch | 1.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy_French | 1.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Sponsor Statement_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Data Privacy Notice_Czech | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnancy data collection_Czech | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Scout ICF_Czech | 2.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main_German_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main_German_tc_Memo to File | 4 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Addendum Right to not know_Danish | 8.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Main_Danish_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Pregnant Partner_Danish_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_Greek | 8.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnant Partner_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_tc_Memo to File | 4 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Scout_Spanish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES-SIS_ICF_Main_Spanish | 8.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_tc_Memo to File | 4 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Scout_French_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnant Partner ICF_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Scout_Polish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Scout Email Confirmation_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Scout Study Brochure_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Subject Card_Czech | 1.0 |
| Subject information and informed consent form (for publication) | Supporting Document_SP Part II RFI response | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01 | Amendment2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_Danish | Amendment1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_Dutch | Amendment2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_French | Amendment2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_French_tc_Memo to File | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_German | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_German_tc_Memo to File | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_Greek | Amendment2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_Italian | Amendment2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-500138-27-01_Polish | Amendment2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_Spanish | Amendment2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500138-27-01_Spanish_tc_Memo to File | 2 |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-21 | France | Acceptable 2022-11-15
|
2022-11-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-02-15 | France | Acceptable 2023-04-14
|
2023-04-17 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-07-18 | Acceptable 2023-04-14
|
2023-10-02 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2023-07-18 | 2023-10-09 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-11 | France | Acceptable | 2023-09-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-08-11 | Acceptable | 2023-09-12 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2023-10-17 | Acceptable 2023-04-14
|
2023-12-22 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2023-10-18 | Acceptable 2023-04-14
|
2024-01-26 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2023-11-27 | Acceptable 2023-04-14
|
2024-02-01 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-03-18 | France | Acceptable 2024-05-03
|
2024-05-06 |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-08-09 | Acceptable | 2024-10-17 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-28 | France | Acceptable 2025-04-24
|
2025-04-24 |
| 13 | SUBSEQUENT ADDITION OF MSC | APP-13 | 2025-06-30 | 2025-09-24 | ||
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-30 | Acceptable | 2025-08-11 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-13 | France | Acceptable | 2026-02-13 |