Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
901
Countries
13
Sites
68
Relapsed or Refractory Multiple Myeloma (RRMM)
To compare the progression-free survival (PFS) of mezigdomide, bortezomib and dexamethasone (MeziVd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM)
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Nov 2022 → ongoing
- Decision date (initial)
- 2024-07-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509859-13-00
- EudraCT number
- 2021-001957-30
- WHO UTN
- U1111-1267-6857
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety, Pharmacodynamic, Pharmacogenomic, Pharmacokinetic
To compare the progression-free survival (PFS) of mezigdomide, bortezomib and dexamethasone (MeziVd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM)
Secondary objectives 7
- In Stage 1, to determine the dose of mezigdomide in combination with bortezomib and dexamethasone to continue in Stage 2 of the study
- In Stage 1, to determine the plasma concentrations of mezigdomide in combination with bortezomib and dexamethasone
- To compare overall survival (OS) between MeziVd and PVd in subjects with RRMM
- To evaluate additional efficacy parameters in subjects with RRMM treated with MeziVd compared to PVd
- To evaluate minimal residual disease (MRD) negativity rate in subjects treated with MeziVd compared to those treated with PVd
- To evaluate safety of MeziVd compared to PVd in subjects with RRMM
- In subjects randomized to Stage 2, to evaluate cancer-related symptoms and health related quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQC30) and the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) in subjects treated with MeziVd compared to PVd
Conditions and MedDRA coding
Relapsed or Refractory Multiple Myeloma (RRMM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086466 | Relapsed/refractory multiple myeloma | 100000004848 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. additional Infromation regarding Bristol-Myers Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Subject has documented diagnosis of MM and measurable disease, defined as: —M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or —For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio
- Subject has received 1 to 3 prior anti-myeloma lines of therapy
- Subject must have received prior treatment with a lenalidomide containing regimen. For country-specific requirements, see APPENDIX I
- Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy
- Subject must have documented disease progression during or after their last antimyeloma regimen
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Exclusion criteria 3
- Subject has had prior treatment with mezigdomide or pomalidomide
- Subject has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below: a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded.
- For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression free Survival (PFS)
Secondary endpoints 14
- Recommended mezigdomide dose
- Pharmacokinetics
- Overall Survival (OS)
- Overall Response Rate (OR)
- Complete Response Rate (CR) or better
- Very Good Partial Response Rate (VGPR) or better
- Time to Response (TTR)
- Duration of Response (DOR)
- Time to Progression (TTP)
- Time to Next Treatment (TTNT)
- Progression-free survival 2 (PFS-2)
- Minimal residual disease (MRD) negativity
- Safety
- Health Related Quality of Life (HRQoL) Evaluation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD9852270 · Product
- Active substance
- Mezigdomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD9757438 · Product
- Active substance
- Mezigdomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD9757642 · Product
- Active substance
- Mezigdomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD9757763 · Product
- Active substance
- Mezigdomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD9757716 · Product
- Active substance
- Mezigdomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD9852263 · Product
- Active substance
- Mezigdomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 10
VELCADE 1 mg powder for solution for injection
PRD703635 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/002
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethason-ratiopharm® 4 mg Tabletten
PRD668856 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 54668.00.00
- MA holder
- RATIOPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD808393 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 33652.00.00
- MA holder
- GALENPHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 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
- No
Dexamethason CF 20 mg/ml, injectievloeistof
PRD502494 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- RVG 55091
- MA holder
- CENTRAFARM B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260810 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/006
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260813 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/007
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260814 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(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
- No
- Modified vs. Marketing Authorisation
- No
PRD9260804 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 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
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Other |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other |
| Frontage Laboratories (Shanghai) Co. Ltd. ORG-100047384
|
Shanghai, China | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Hematogenix Laboratory Services Limited ORG-100047188
|
Cheadle, United Kingdom | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis |
| Icon (Lr) Limited ORG-100042612
|
Dublin 18, Ireland | Other |
Locations
13 EU/EEA countries · 68 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 20 | 5 |
| Belgium | Ongoing, recruitment ended | 25 | 4 |
| Czechia | Ongoing, recruitment ended | 14 | 3 |
| Finland | Ongoing, recruitment ended | 16 | 2 |
| France | Ongoing, recruitment ended | 64 | 11 |
| Germany | Ongoing, recruiting | 35 | 15 |
| Greece | Ongoing, recruitment ended | 24 | 3 |
| Ireland | Ongoing, recruitment ended | 23 | 3 |
| Italy | Ongoing, recruitment ended | 24 | 5 |
| Poland | Ongoing, recruitment ended | 12 | 4 |
| Portugal | Ongoing, recruitment ended | 8 | 3 |
| Romania | Ongoing, recruitment ended | 10 | 3 |
| Spain | Ongoing, recruitment ended | 50 | 7 |
| Rest of world
Israel, United States, United Kingdom, Japan, Argentina, Canada, Brazil, China, Turkey, Korea, Republic of, Australia
|
— | 576 | — |
Investigational sites
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
3rd Medical Department, Heinrich-Collin-Strasse 30, Penzing, Vienna
Stadt Wien Wiener Gesundheitsverbund
1st Medical Department, Center for Oncology and Hematology, Montleartstrasse 37, Ottakring, Vienna
Noe LGA Gesundheit Region Mitte GmbH
Clinical Department for Internal Medicine I, Dunant-Platz 1, 3100, St. Poelten
Universitaetsklinikum Krems
Clinical Department for Internal Medicine II, Mitterweg 10, 3500, Krems An Der Donau
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department for Hemato-Oncology, Vordernberger Strasse 42, 8700, Leoben
Het Ziekenhuisnetwerk Antwerpen
Hematology, Kempenstraat 100, 2030, Antwerp
Vitaz
Medical Oncology/Hematology, Moerlandstraat 1, 9100, Sint-Niklaas
Ziekenhuis Oost Limburg
Hematology, Synaps Park 1, 3600, Genk
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika FN Brno, Jihlavska 340/20, Bohunice, Brno
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika - klinika hematologie 1.LF a VFN, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Kralovske Vinohrady
Hematologicka klinika, Srobarova 1150/50, Vinohrady, Prague
Kuopio University Hospital
Department of Hematology, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
HUS-Yhtymae
Comprehensive cancer center, Haartmaninkatu 4, 00290, Helsinki
Centre Hospitalier Regional Universitaire De Tours
Hematology, 2 Boulevard Tonnelle, 37000, Tours
University Hospital Of Clermont-Ferrand
Hematology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Assistance Publique Hopitaux De Paris
Hematology, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Bordeaux
Hematology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nimes
Hematology, Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
Centre Hospitalier Et Universitaire De Limoges
Hematology, 2 Avenue Martin Luther King, 87000, Limoges
Institut De Cancerologie Strasbourg Europe
Hematology, 17 Rue Albert Calmette, 67200, Strasbourg
Centre Hospitalier Universitaire De Nantes
Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
Hematology, Rue Michel Polonovski, 59037, Lille Cedex
Les Hopitaux Universitaires De Strasbourg
Hematology, 1 Place De L Hopital, 67000, Strasbourg
Centre Leon Berard
Hematology, 28 Rue Laennec, 69008, Lyon
Haematologisch Onkologische Schwerpunktpraxis
Hematology-oncology specialist practice, Schweinfurter Strasse 7, Altstadt, Wuerzburg
Universitaetsklinikum Schleswig-Holstein AöR
Medical Clinic Section for Stem Cell and Immunotherapy, Arnold-Heller-Strasse 3, Brunswik, Kiel
University Medical Center Hamburg-Eppendorf
II. Medical Clinic & Polyclinic Center for Oncology, Martinistrasse 52, Eppendorf, Hamburg
Praxis Onkologie am Raschplatz Hannover
Studienzentrum, Rundestraße 10, 30161, Hannover
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Clinic and Polyclinic for Internal Medicine II, Ismaninger Strasse 22, Au-Haidhausen, Munich
Marien Hospital Duesseldorf GmbH
Klinik für Onkologie, Hämatologie und Palliativmedizin, Rochusstrasse 2, Pempelfort, Duesseldorf
Universitaetsklinikum Aachen AöR
Clinic for Hematology, Oncology, Hemostaseology and Stem Cell Transplant (Medical clinic IV), Pauwelsstrasse 30, 52074, Aachen
Sozialstiftung Bamberg
Sozialstiftung Bamberg, Klinikum am Bruderwald, Buger Strasse 80, Berg, Bamberg
MVZ Nordoberpfalz GmbH
Department of Oncology and Hematology at Medical Care Center Nordoberpfalz, Soellnerstrasse 16, Scheibe, Weiden I.D.Opf.
Universitaetsklinikum Tuebingen AöR
Internal Medicine II, Dept. of Oncology, Hematology, Rheumatology, Immunology, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Kliniken Suedostbayern AG
Department for Hematology, Oncology and Palliative Medicine, Cuno-Niggl-Strasse 3, 83278, Traunstein
Gemeinschaftspraxis Haematologie Onkologie
Gemeinschaftspraxis Freiberg-Richter, Jacobasch, Illmer, Wolf Haematologie, Onkologie, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Philipps-Universitaet Marburg
Center for Internal Medicine; Clinic for Hematology, Oncology and Immunology, Baldingerstrasse, 35043, Marburg
Asklepios Kliniken Hamburg GmbH
Asklepios Klinik Altona, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Universitaetsklinikum Bonn AöR
Medical Clinic and Polyclinic III - Internal Medicine - Focus: Hemato-Oncology, Immuno-Oncology, Venusberg-Campus 1, Venusberg, Bonn
Evaggelismos Hospital
Hematology and Lymphoma/Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
Alexandra Hospital
Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department of Haematology- Haematopoietic Cell Transplantation Centre, Exochi, 570 10, Thessaloniki
Cork University Hospital
Oncology, Wilton, T12 DC4A, Cork
University Hospital Galway
Oncology, Newcastle Road, H91 YR71, Galway
St James's Hospital
Oncology, James's Street, D08 NHY1, Dublin 8
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Onco-Hematology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Sant Andre
UOC Ematologia, Via Di Grottarossa 1035-1039, 00189, Rome
Fondazione IRCCS Policlinico San Matteo
UOC Ematologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Istituto di Ematologia "L e A Seragnoli", Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
UOC Ematologia, Via Santa Sofia 78, 95123, Catania
Pratia Hematologia Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Oddzial Hematologii i Translantacji, Ul. Hubalczykow 1, 76-200, Slupsk
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
MICS Centrum Medyczne Torun
N/A, Ul. Batorego 18-22, 87-100, Torun
Champalimaud Clinical Centre
Unidade de Hemato-Oncologia, Avenida Brasilia S/n, 1400-038, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Onco-Hematologia, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
CCAB Centro Clinico Academico Braga Associacao
Unidade de Investigação Clínica, Lugar De Sete Fontes S Victor, 4710-243, Braga
Institutul Regional De Oncologie Iasi
Hematology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institutul Clinic Fundeni
Hematology, Soseaua Fundeni 258, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
University Hospital Son Espases
Hematology, Carretera Valldemossa 79, 07120, Palma
Hospital Costa Del Sol
Hematology, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital General Universitario Morales Meseguer
Hematology and Medical Oncology, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario De Leon
Hematology, C Altos De Nava S/n, 24071, Leon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-11-09 | 2023-02-03 | 2026-02-10 | ||
| Belgium | 2022-12-19 | 2023-02-01 | 2026-02-10 | ||
| Czechia | 2023-12-22 | 2024-07-23 | 2026-02-10 | ||
| Finland | 2023-04-13 | 2023-06-26 | 2026-02-10 | ||
| France | 2022-11-22 | 2023-01-25 | 2026-02-10 | ||
| Germany | 2022-12-23 | 2023-02-02 | |||
| Greece | 2024-08-22 | 2024-08-22 | 2026-02-10 | ||
| Ireland | 2023-09-20 | 2023-10-26 | 2026-02-10 | ||
| Italy | 2023-02-13 | 2023-03-07 | 2026-02-10 | ||
| Poland | 2023-11-15 | 2023-12-06 | 2026-02-10 | ||
| Portugal | 2023-06-12 | 2023-12-15 | 2026-02-10 | ||
| Romania | 2023-02-23 | 2023-03-21 | 2026-02-10 | ||
| Spain | 2022-11-25 | 2023-03-20 | 2026-02-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 171 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-509859-13-00 GR Redacted | 07 |
| Protocol (for publication) | D1_Protocol 2023-509859-13-00 Redacted | 07 |
| Protocol (for publication) | D1_Protocol Admin letter_Redacted | NA |
| Protocol (for publication) | D4_Blank statement_Patient facing documents-Questionnaires_ES | NA |
| Protocol (for publication) | D4_Blank statement_Patient facing documents-Questionnaires_FR | 1 |
| Protocol (for publication) | D4_Patient Facing Documents redaction statement_GR | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_Statement for publication_IT | 1 |
| Protocol (for publication) | D4_patient facing documents_statement_under license PL | N/A |
| Protocol (for publication) | D4_Patient facing questionnaires_redaction statement_EN | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_PT | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_AT_ger | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_BE | V01 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_CZ | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_DEU_ger | 1 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment and Informed Consent Procedures | 02 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_FR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_PT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_RO | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_PL | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_ES | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_IT_Clean | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_AT | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_GR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_TC | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_GR | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IE | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | na |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_IT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HCP Brochure_GR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient flyer_DE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_StudyOverviewSheet_FR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_StudyOverviewSheet_FR_TC | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IE_Patient Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IE_StudyOverviewSheet_ENG | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Brochure_ES | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Greenphire_RO | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted_RO | 8 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner EN | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partner_RO | 2.3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Patient EN | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant patient_RO | 2.1 |
| Subject information and informed consent form (for publication) | L1_Data Privacy Form_CZ_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS and ICF_FI_Pregnant partner_no redaction needed | 2 |
| Subject information and informed consent form (for publication) | L1_FI_SIS and ICF_FI_Pregnant patient_no redaction needed | 2 |
| Subject information and informed consent form (for publication) | L1_FI_SIS and ICF_FI_Subject leaflet _FIN_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_FI_SIS and ICF_Main_FIN_Redacted | 8.- |
| Subject information and informed consent form (for publication) | L1_SIS and Additional Optional Consent_FR_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and French Consent_FR_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and French Patient IS_Included patients_FR_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and French Patient IS_new patients_FR_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Addendum Greenphire _PL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Data Privacy_PL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Main_Redacted_PL | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Pregnant Partner_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Pregnant Subject_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biopsy_FR_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnanat Participants GR_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partners GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main GR_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_AT_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DE_redacted | 9 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES_Redacted | 9 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Research_DE_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Research_PT | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner SOC_FR_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_DE | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ES_no redaction needed | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_FR_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PT | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PT_TC | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_TC | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Patient_DE | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Patient_ES_no redaction needed | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant patient_New patient_FR_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant patient_previous patient_FR_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Patient_PT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_ENG_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_FRA_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_NLD_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner IC_ENG_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner IC_FRA_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner IC_NLD_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Patient IC_ENG_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Patient IC_FRA_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Patient IC_NLD_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IE_Female Subject Pregnancy Consent_ENG_Clean | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IE_Female Subject Pregnancy Consent_RUS_Clean | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IE_Main_ENG_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IE_Main_RUS_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IE_Partner Pregnancy Consent Form_ENG_Clean | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_already enrolled study participant_CZ_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_IT_Clean_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_new participant_CZ_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Research_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Research_CZ_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_IT_cln | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_AT | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_IT_cln | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Patient_AT | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Patient_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Patient_CZ_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Trattamento dati personali_IT_cln_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Travel reimbursement_IT_cln_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and Main ICF_PT_redacted | 9 |
| Subject information and informed consent form (for publication) | L2_Global Pregnancy Prevention Plan Mezigdomide | 5.0 |
| Subject information and informed consent form (for publication) | L2_Global Pregnancy Prevention Plan Pomalidomide | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material PPP Mezigdomide_No redactions needed | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material PPP Pomalidomidi_No redactions needed | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Contact Info Sheet_AT | 4 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide PPP complete_AT | 6 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide PPP complete_DE | 6 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide PPP_AT | 4 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide PPP_DE | 4 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide PPP_IT_Clean | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide PPP_Patient Information Sheet_ENG | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide PPP_Patient Information Sheet_RUS | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_Patient information Sheet_PPP_PL | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP with TC__PL | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP_BE_ENG_no redaction needed | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP_BE_FRA_no redaction needed | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP_BE_NLD_no redaction needed | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP_CZ_TC | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP_ES | 6 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP_PT | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mezigdomide_PPP_RO | 6 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide PPP_ Patient Information Sheet_ENG | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide PPP_ Patient Information Sheet_RUS | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide PPP_AT | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide PPP_DE | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide PPP_IT | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_Patient information Sheet_PPP | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_Patient information Sheet_PPP_PL | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_PPP | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_PPP_BE_ENG_no redaction needed | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_PPP_BE_FRA_no redaction needed | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_PPP_BE_NLD_no redaction needed | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_PPP_RO | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_PPP_v4_1_29Jul2022_ES | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pomalidomide_PPP_v4_1_29Jul2022_PT | 4.1 |
| Subject information and informed consent form (for publication) | L2_Subject information sheet Pregnancy Prevention Mezigdomide_FR | 6.0 |
| Subject information and informed consent form (for publication) | L2_Subject information sheet Pregnancy Prevention Pomalidomide_FR | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bortezomib | 46 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone Aspen | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone Centrafarm | 10.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone Centrafarm_Dutch | 10 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis EU CT 2023-509859-13_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-509859-13-00_CZ | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_2023-509859-13 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-509859-13 GR_CL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-509859-13_AT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-509859-13_BE_DEU | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-509859-13_BE_FRA | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-509859-13_BE_NLD | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-509859-13_ES | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-509859-13_FR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-509859-13_PT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-509859-13-00_EN | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_EU CT_2023-509859-13 | 2 |
Application history
31 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-25 | Czechia | Acceptable 2024-06-18
|
2024-06-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-26 | Czechia | Acceptable 2024-06-18
|
2024-08-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-29 | Acceptable 2024-06-18
|
2024-08-29 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-08-29 | Acceptable 2024-06-18
|
2024-08-29 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-08-29 | Acceptable 2024-06-18
|
2024-08-29 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-08-29 | Acceptable 2024-06-18
|
2024-08-29 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-08-30 | Acceptable 2024-06-18
|
2024-08-30 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-20 | Czechia | Acceptable 2025-01-15
|
2025-01-15 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-01-21 | Acceptable 2025-01-15
|
2025-01-21 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-01-22 | Acceptable 2025-01-15
|
2025-01-22 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-01-22 | Acceptable 2025-01-15
|
2025-01-22 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-23 | Acceptable | 2025-02-24 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2025-02-28 | Acceptable | 2025-02-28 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-07 | Czechia | Acceptable with conditions 2025-07-11
|
2025-07-14 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-12 | 2025-07-22 | Czechia | Acceptable with conditions 2025-07-11
|
2025-07-22 |
| 16 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-23 | Acceptable with conditions | 2025-08-19 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-24 | Acceptable with conditions | 2025-09-01 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-25 | Acceptable with conditions | 2025-09-09 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-28 | Acceptable with conditions | 2025-09-05 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-07-28 | Acceptable with conditions | 2025-09-01 | |
| 21 | NON SUBSTANTIAL MODIFICATION | NSM-13 | 2025-09-25 | Acceptable with conditions | 2025-09-25 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-11-19 | Czechia | Acceptable with conditions 2026-03-09
|
2026-03-09 |
| 23 | NON SUBSTANTIAL MODIFICATION | NSM-14 | 2026-03-17 | Acceptable with conditions 2026-03-09
|
2026-03-17 | |
| 24 | NON SUBSTANTIAL MODIFICATION | NSM-15 | 2026-03-17 | Acceptable with conditions 2026-03-09
|
2026-03-17 | |
| 25 | NON SUBSTANTIAL MODIFICATION | NSM-16 | 2026-03-17 | Acceptable with conditions 2026-03-09
|
2026-03-17 | |
| 26 | NON SUBSTANTIAL MODIFICATION | NSM-17 | 2026-03-18 | Acceptable with conditions 2026-03-09
|
2026-03-18 | |
| 27 | NON SUBSTANTIAL MODIFICATION | NSM-18 | 2026-03-18 | Acceptable with conditions 2026-03-09
|
2026-03-18 | |
| 28 | NON SUBSTANTIAL MODIFICATION | NSM-19 | 2026-03-19 | Acceptable with conditions 2026-03-09
|
2026-03-19 | |
| 29 | NON SUBSTANTIAL MODIFICATION | NSM-20 | 2026-03-19 | Acceptable with conditions 2026-03-09
|
2026-03-19 | |
| 30 | NON SUBSTANTIAL MODIFICATION | NSM-21 | 2026-03-20 | Acceptable with conditions 2026-03-09
|
2026-03-20 | |
| 31 | NON SUBSTANTIAL MODIFICATION | NSM-22 | 2026-03-24 | Acceptable with conditions 2026-03-09
|
2026-03-24 |