Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
681
Countries
12
Sites
57
Newly Diagnosed Multiple Myeloma with Suboptimal Response After Autologous Stem Cell Transplantation
To compare the efficacy of ide-cel with Lenalidomide maintenance to that of Lenalidomide (LEN) maintenance alone in participants who achieved suboptimal response to Autologous Stem Cell Transplantation (ASCT) as measured by Progression Free Survival (PFS).
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
- 25 Sep 2023 → ongoing
- Decision date (initial)
- 2023-09-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Celgene Corporation
External identifiers
- EU CT number
- 2022-501346-30-00
- WHO UTN
- U1111-1280-9736
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Pharmacogenetic, Pharmacoeconomic, Efficacy, Safety, Therapy
To compare the efficacy of ide-cel with Lenalidomide maintenance to that of Lenalidomide (LEN) maintenance alone in participants who achieved suboptimal response to Autologous Stem Cell Transplantation (ASCT) as measured by Progression Free Survival (PFS).
Secondary objectives 6
- To compare the efficacy of ide-cel with LEN maintenance to that of LEN maintenance alone in participants who achieved suboptimal response to ASCT as measured by Overall Survival (OS).
- To compare the efficacy of ide-cel with LEN maintenance to that of LEN maintenance alone in participants who achieved suboptimal response to ASCT as measured by Minimal Residual Disease Negative (MRDneg) Complete Response (CR) rate.
- To compare additional efficacy parameters between ide-cel with LEN maintenance and of LEN maintenance alone in participants who achieved suboptimal response to ASCT.
- To assess the safety of ide-cel with LEN maintenance relative to LEN maintenance alone in participants who achieved suboptimal response to ASCT.
- To characterize the expansion and persistence of CAR T cells in the peripheral blood (cellular kinetics-PK) in participants treated with ide-cel with LEN maintenance.
- To assess key Multiple Myeloma symptoms, functioning, and overall Quality of Life in participants treated with ide-cel with LEN maintenance or LEN maintenance alone.
Conditions and MedDRA coding
Newly Diagnosed Multiple Myeloma with Suboptimal Response After Autologous Stem Cell Transplantation
| 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
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information 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 5
- Participants aged ≥18 with NDMM who have received induction therapy followed by high-dose chemotherapy and ASCT, without subsequent maintenance. EXCEPTION:Participant received ≤ 7 days of LEN maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
- Participant must have received a minimum of 4 cycles of induction therapy that includes an IMiD anda PI (with or without anti-CD38 monoclonal antibody) prior to a single ASCT. A maximum of 6 cycles is permitted (which can include up to 2 cycles of post-ASCT consolidation if given). For participants who have not received post-ASCT consolidation therapy, the participant must be within 80 to 120 days post transplant at the time of consent. For participants treated with post-ASCT consolidation therapy, the participant must be within 30 to 60 days of the last dose of consolidation therapy at the time of consent and within 180 days post transplant at the time of consent.Note: Participant must not have confirmed progression since commencing induction. When screening results are suggestive of progression, repeat assessments must beperformed to exclude PD per International Myeloma Working Group.
- Participant must have documented best overall response of PR or VGPR at time of randomization.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator’s discretion).
- Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Exclusion criteria 5
- Participant with known central nervous system involvement with myeloma.
- Participant has non-secretory MM or oligosecretory MM at diagnosis.
- Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
- Participant has history of primary immunodeficiency.
- Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression Free Survival (PFS)
Secondary endpoints 18
- Overal Surival (OS)
- Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
- Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
- Event-Free Survival (EFS)
- Duration of Response (DOR)
- Percentage of Participants with Complete Response (CR)
- Time to Progression (TTP)
- Progression post-next line of treatment (PFS2)
- Time to Next Treatment (TTNT)
- Number of Participants Experiencing Adverse Events (AEs).
- Number of Participants Experiencing Adverse Events of Special Interest (AESI)
- Maximum Observed Plasma Concentration (Cmax)
- Time of Maximum Observed Plasma Concentration (Tmax)
- Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0-28D])
- Time of Last Measurable Observed Plasma Concentration (Tlast)
- Time-to-Definitive Deterioration
- Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
- Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10119543 · Product
- Active substance
- Idecabtagene Vicleucel
- Pharmaceutical form
- CELL SUSPENSION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 460 Other
- Max total dose
- 460 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/17/1863
Comparator 4
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 36960 mg milligram(s)
- Max treatment duration
- 89 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lenalidomide capsules for commercial use will be removed from their primary packaging (blisters) and put into bottle labeled for clinical trial use.
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 36960 mg milligram(s)
- Max treatment duration
- 89 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lenalidomide capsules for commercial use will be removed from their primary packaging (blisters) and put into bottle labeled for clinical trial use.
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 36960 mg milligram(s)
- Max treatment duration
- 89 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lenalidomide capsules for commercial use will be removed from their primary packaging (blisters) and put into bottle labeled for clinical trial use.
PRD9264293 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 36960 mg milligram(s)
- Max treatment duration
- 89 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/005
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lenalidomide capsules for commercial use will be removed from their primary packaging (blisters) and put into bottle labeled for clinical trial use.
Auxiliary 10
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154624 · Product
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, ATLIZUMAB, TOCILIZUMABUM
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 32 mg/kg milligram(s)/kilogram
- Max total dose
- 32 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/005
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01769MIG · Substance
- Active substance
- Diphenhydramine Hydrochloride
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine Accord, 25 mg/ml, koncentrat do sporzadzania roztworu do wstrzykiwan lub infuzji
PRD3972993 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/sq. meter
- Max total dose
- 180 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 23072
- MA holder
- ACCORD HEALTHCARE POLSKA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD351417 · Product
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 300 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- 6035903.00.00
- MA holder
- BAXTER ONCOLOGY GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Neoflubin 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung
PRD719854 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/sq. meter
- Max total dose
- 180 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 1-27630
- MA holder
- EBEWE PHARMA
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bendarabin 50 mg Pulver zur Herstellung einer Injektions- oder Infusionslösung
PRD2832962 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/sq. meter
- Max total dose
- 180 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 69663.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FLUDARABINE ACCORD 25 mg/ml, solution à diluer pour solution injectable/pour perfusion
PRD5781661 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/sq. meter
- Max total dose
- 180 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 34009 301 326 5 4
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD731214 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/sq. meter
- Max total dose
- 180 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 64929.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabin HEXAL® 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung
PRD766198 · Product
- Active substance
- Fludarabine Phosphate Ph. Eur.
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/sq. meter
- Max total dose
- 180 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 74371.00.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 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
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 |
|---|---|---|
| Neogenomics Laboratories Inc. ORG-100041804
|
Aliso Viejo, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Data management |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other, Interactive response technologies (IRT) |
| Cellcarta Biosciences Inc. ORG-100042227
|
Montreal, Canada | Laboratory analysis |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Iqvia Inc. ORG-100010622
|
Durham, United States | On site monitoring, Code 10, Code 11, Code 12, Code 2, Data management, Code 8, Code 9 |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other |
| Q2 Solutions ORL-000000243
|
West Lothian, United Kingdom | Other, Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Other |
| Labcorp Drug Development Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 10, Code 11, Code 12, Code 2, Data management, Code 8, Code 9 |
Locations
12 EU/EEA countries · 57 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 9 | 2 |
| Belgium | Ended | 12 | 3 |
| Czechia | Ended | 28 | 4 |
| Denmark | Ended | 6 | 1 |
| France | Ongoing, recruitment ended | 69 | 11 |
| Germany | Ended | 57 | 10 |
| Greece | Ended | 26 | 4 |
| Italy | Ongoing, recruitment ended | 24 | 5 |
| Norway | Ongoing, recruitment ended | 9 | 1 |
| Poland | Ongoing, recruitment ended | 39 | 6 |
| Romania | Ongoing, recruitment ended | 9 | 2 |
| Spain | Ongoing, recruitment ended | 44 | 8 |
| Rest of world
Canada, Japan, United Kingdom, Australia, Israel, United States, Korea, Republic of
|
— | 349 | — |
Investigational sites
Medical University Of Vienna
Klinik für Innere Medizin I, Waehringer Guertel 18-20, Alsergrund, Vienna
SCRI CCCIT Ges.m.b.H.
Innere Medizin III der PMU, Muellner Hauptstrasse 48, 5020, Salzburg
Cliniques Universitaires Saint-Luc
Hematology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut Jules Bordet
Hematology, Mijlenmeersstraat 90, 1070, Brussels
UZ Brussel
Medical Hematology, Laarbeeklaan 101, 1090, Jette
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika - klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague
University Hospital Olomouc
Hemato-onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Hradec Kralove
IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Centre Hospitalier Universitaire De Poitiers
Hématologie et thérapie cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Institut Gustave Roussy
Médecine Interne, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Lyon Sud
Hématologie clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Assistance Publique Hopitaux De Paris
Immuno-Hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
Assistance Publique Hopitaux De Paris
Hémopathies Lymphoides, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncopole_ Service Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Service Hematologique et Thérapie Cellulaire, Avenue De Magellan, 33600, Pessac
Institut Paoli-Calmettes
Onco-hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Assistance Publique Hopitaux De Paris
Hématologie et Thérapie Cellulaire, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Lille
Service des maladies du sang, Rue Michel Polonovski, 59037, Lille Cedex
Hospital Hotel Dieu
Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
University Medical Center Hamburg-Eppendorf
Klinik für Onkologie, Hämatologie, Knochenmarkstransplantation und Klinik für Pneumologie, Martinistrasse 52, Eppendorf, Hamburg
Klinikum Nuernberg
Medizinische Klinik 5, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Universitaetsklinikum Leipzig AöR
Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, Johannisallee 32a, Zentrum-Suedost, Leipzig
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik 1, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Innere Medizin II, Arnold-Heller-Strasse 3, Brunswik, Kiel
University Hospital Cologne AöR
Klinik für Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Wuerzburg AöR
Klinik für Innere Medizin II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik, Abteilung Innere Medizin V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
General University Hospital Of Patras
Bone Marrow Transplantation Unit, Rio, 265 04, Patras
Evaggelismos Hospital
Hematology Clinic, Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
University General Hospital Attikon
2nd Department of Internal Medicine, Division of Hematology, Rimini Street 1, 124 62, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
DEPARTMENT OF HAEMATOLOGY - HAEMATOPOIETIC CELL TRANSPLANTATION CENTRE, Exochi, 570 10, Thessaloniki
Humanitas Research Hospital
Oncologia medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
SS Trapianto allogenico e terapie cellulari-SC Ematologia U, Corso Bramante 88, 10126, Turin
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
Istituto Nazionale Dei Tumori
Dipartimento di Oncologia ed Emato-Oncologia, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospealiero Universitaria Policlinico Umberto I
UOC di Ematologia, Viale Del Policlinico 155, 00161, Rome
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Kilinika Hematologii, Tranplantologii i Chorób Wewnętrznych, Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddzial Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Centrum Onkologii Ziemi Lubelskiej Im Sw Jana Z Dukli
N/A, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Fundeni Clinical Institute
Hematology, Soseaua Fundeni 258, 022328, Bucharest
Institutul Regional De Oncologie Iasi
Hematology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
University Clinic Of Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Catalan Institute Of Oncology
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Catalan Institute Of Oncology
Hematology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
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 | 2023-10-18 | 2024-09-25 | 2024-04-18 | 2024-09-25 | |
| Belgium | 2023-10-13 | 2025-05-12 | 2023-11-02 | 2024-09-25 | |
| Denmark | 2024-06-12 | 2024-09-25 | |||
| France | 2023-09-25 | 2024-01-02 | 2024-09-25 | ||
| Germany | 2024-09-02 | 2024-09-25 | |||
| Greece | 2023-12-21 | 2025-02-13 | 2024-07-11 | 2024-09-25 | |
| Italy | 2023-11-17 | 2023-11-23 | 2024-10-10 | ||
| Norway | 2023-09-27 | 2023-10-23 | 2024-09-25 | ||
| Poland | 2023-12-15 | 2024-01-22 | 2024-10-03 | ||
| Romania | 2023-11-16 | 2024-01-12 | 2024-10-04 | ||
| Spain | 2023-09-27 | 2023-10-16 | 2024-09-25 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-09-10
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-09-10
- Immediate action required
- Yes
- Notes
- Reverted (2025-09-10)
- Justification
- Dear Applicant,
Considering the expiration of the three-year mandate of the members of the National Ethics Committee (CEN) for clinical trials relating to advanced therapies (“ATMP”) and of the National Ethics Committee (CEN) for clinical trials in the pediatric field, appointed by Decree of the Minister of Health - 2 March 2022;
Considering the fact that, due to the expiration of the mandate of the members of the aforementioned National Ethics Committee (CEN), for the procedure in subject the assessment of the aspects relating to Part II of the evaluation report pursuant to art. 7 of the aforementioned Regulation (EU) No. 536/2014 has not been carried out, and as a result there is no conclusion of Part II for the EU CT 2022-501346-30-00 procedure (AIFA authorization provision n° 0086443);
In compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 176 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol Greek EUCTR 2022-501346-30-00 Redacted | 2.0 |
| Protocol (for publication) | D1_Dear Investigator Letter_2022-501346-30-00_Redacted | NA |
| Protocol (for publication) | D1_Protocol 2022-501346-30-00_Redacted | 5 |
| Protocol (for publication) | D1_Protocol Admin Letter 2022-501346-30-00_Redacted | NA |
| Protocol (for publication) | D4 Statement on validated questionnaires EQ-5D-5L_MY20_QLQ-C30_under license PL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Questionnaire_redacted placeholder_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_eCOA not for publication statement_CZ_CS_public | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Digital Int_ES_For publication_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Digital Self-C_ES_For publication_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L_FR_For Publication_Statement under Licence | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire MY20_FR_For Publication_Statement under Licence | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30_FR_For Publication_Statement under Licence | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_EQ-5D-5L Digital Interv. Admin._ENG_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_EQ-5D-5L Digital Interv. Admin._FRA_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_EQ-5D-5L Digital Interv. Admin._NLD_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_EQ-5D-5L Digital Self-Complete_ENG_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_EQ-5D-5L Digital Self-Complete_FRA_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_EQ-5D-5L Digital Self-Complete_NLD_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_MY20_ENG_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_MY20_FRA_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_MY20_NLD_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_QLQC-C30_ENG_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_QLQC-C30_FRA_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BE_QLQC-C30_NLD_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_MY20_ES_For publication_Statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_QLQ-C30_ES_For publication_Statement | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_AT | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_DE | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_GR | 1 |
| Recruitment arrangements (for publication) | K1 CA089-1043 Template recruitment arrangements Redacted | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements_clean_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements_clean_Redacted | 2 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements_PL_ | 4 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_IT_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Redacted | N/A |
| Recruitment arrangements (for publication) | K1_DE_Recruitment arrangements_CL | 2 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment arrangements Sponsor_Redacted | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_BE | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_redacted_FR | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_AT_CL | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ_public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Material Brochure_GR | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Material Poster_GR | 2.0 |
| Recruitment arrangements (for publication) | K2_AT_Recruitment material_Recruitment brochure | 2 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment material_Recruitment brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruimtent material_BE_Brochure_ENG_Statement | NA |
| Recruitment arrangements (for publication) | K2_Recruimtent material_BE_Brochure_FRA_Statement | NA |
| Recruitment arrangements (for publication) | K2_Recruimtent material_BE_Brochure_NLD_Statement | NA |
| Recruitment arrangements (for publication) | K2_Recruimtent material_BE_Poster_ENG_Statement | NA |
| Recruitment arrangements (for publication) | K2_Recruimtent material_BE_Poster_FRA_Statement | NA |
| Recruitment arrangements (for publication) | K2_Recruimtent material_BE_Poster_NLD_Statement | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material Brochure_GR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Poster_GR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment brochure_CZ_public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment brochure_ITA_public | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_PL | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster_ITA_public | 1 |
| Subject information and informed consent form (for publication) | L1 Exception release IC_nor_clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 Future research IC_clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 ICF for Exception Release Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 ICF for Pregnant Partner Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 ICF for Pregnant Partners TC | 1.1 |
| Subject information and informed consent form (for publication) | L1 ICF Main Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 Main IC _clean_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1 Main IC_nor_clean_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1 Pregnant Partner IC _clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 Pregnant PARTNER ICF_nor_clean_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1 Receive Ide-cel IC_clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Exceptional Release IC PL _Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional Future Research IC PL _Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 Supplement to main IC_dan_Final_Unredact | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Addendum_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF exception release_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Exceptional release_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF FOR PROCESSING PERSONAL DATA_IT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main adult_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_IT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future research_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ subject reimbourse_Administration_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ subject reimbourse_Vendor_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1__SIS_ PPP Lenalidomide_PL | 4 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Inv Futura Opcional_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Main_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF_exception-release_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF_IC Addendum_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF_Pregnant Partner_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS Lenalidomide_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Exceptional Release_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_AT_re-redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum__PL _Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Addendum_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Previous Patients_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FR_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_IC_addendum NEW INFORMATION_ENG_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_IC_addendum NEW INFORMATION_FRE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_IC_Addendum NEW INFORMATION_NLD_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Exceptional Release_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Exceptional Release_DE_red | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IC exceptional-release_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main IC_ FR_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main PL Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_red | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_DE_red | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient Reimbursement IC_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner IC_PL _Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DE_red | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Exception Release IC-ENG-Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Exception Release IC-FRA-Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Exception Release IC-NLD-Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Main IC-ENG-redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Main IC-FRA-Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Main IC-NLD-Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Pregnant Partner IC-ENG-Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Pregnant Partner IC-FRA-Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Pregnant Partner IC-NLD-Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Pregnant Patient IC-ENG-Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Pregnant Patient IC-FRA-Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-Pregnant Patient IC-NLD-Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-BE-sponsorstatement-Main IC-Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Lenalidomide Information Sheet_AT_re-redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_Lenalidomide_Global_PPP_ADULT_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Site Contact Details_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L2 Dine rettigheder som forsgsperson i forsg med medicin_NVK_Not to be redact | 1 |
| Subject information and informed consent form (for publication) | L2 Global PPP _SIS Lenalodomid Unredacted | 1 |
| Subject information and informed consent form (for publication) | L2 Other Subject information mat_ Video Translation_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L2 Other subject information material_Lena PPP_Nor_clean_Unredacted | 4 |
| Subject information and informed consent form (for publication) | L2 Other Subject information material_NO Video Translation_Nor_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L2 Other Subject information material_Storyboard_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2 Other Subject information material_Storyboard_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2 Other Subject information material_Storyboard_Redacted | 2-1 |
| Subject information and informed consent form (for publication) | L2 Other Subject information material_Study overview video Link Redacted | 1 |
| Subject information and informed consent form (for publication) | L2 Other Subject information material_Study overview video Link_Norway_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_SIS LENA_ITA_redacted | 4 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_study overview video link_RO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_study overview video_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_video translation | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CN_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Information Sheet Lenalidomid_DE | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PPP_CZ_public | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_SIS_LENA_GR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Story Board | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Storyboard_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Storyboard_EN_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Overview Video Link_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_study overview video_Video Link PL_Redacted | N/A |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Video translation_AT_unredacted | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_video translation_PL | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material-BE-Lenalidomide-Global-PPP-ADULT-ENG_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material-BE-Lenalidomide-Global-PPP-ADULT-FRA_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material-BE-Lenalidomide-Global-PPP-ADULT-NLD_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other Subjet Material_Guide pedagogique CAR-T_Aidant et patient_FR | 1.1 |
| Subject information and informed consent form (for publication) | S1_SIS and IC Lenalidomide_Redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Revlimid | 53 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis_GR_2022-501346-30-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_AT_2022-501346-30-00_EN_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_AT_2022-501346-30-00_GER_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_RO_EU-CT 2022-501346-30 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2022-501346-30-00_CZ_CS_redacted | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ PL_ 2022-501346-30-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_2022-501346-30-00_DEU-Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_2022-501346-30-00_FRA-Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_2022-501346-30-00_NLD-Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2022-501346-30-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2022-501346-30-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2022-501346-30-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2022-501346-30-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NO_2022-501346-30-00 | 3 |
Application history
27 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-13 | Norway | Acceptable 2023-09-04
|
2023-09-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-09-25 | Norway | Acceptable 2023-09-04
|
2023-09-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-11-08 | Norway | Acceptable 2024-01-30
|
2024-01-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-02-27 | Norway | Acceptable 2024-05-24
|
2024-05-24 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-06-10 | Acceptable 2024-05-24
|
2024-09-05 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-06-11 | Acceptable 2024-05-24
|
2024-08-30 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-06-13 | Acceptable | 2024-08-19 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-06-17 | Acceptable | 2024-07-19 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-06-18 | |||
| 10 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-06-18 | |||
| 11 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-06-18 | |||
| 12 | SUBSTANTIAL MODIFICATION | SM-15 | 2024-07-01 | 2024-08-19 | ||
| 13 | SUBSTANTIAL MODIFICATION | SM-14 | 2024-07-02 | Acceptable | 2024-08-31 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-16 | 2024-07-02 | Acceptable | 2024-08-19 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-17 | 2024-07-03 | 2024-08-19 | ||
| 16 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-07-08 | Acceptable | 2024-09-09 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-09-09 | 2024-09-09 | ||
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-09-10 | 2024-09-10 | ||
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2024-09-10 | 2024-09-10 | ||
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2024-09-10 | 2024-09-10 | ||
| 21 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2024-09-12 | Norway | 2024-09-12 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-21 | 2024-12-13 | Norway | Acceptable 2025-04-07
|
2025-04-07 |
| 23 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-04-15 | Acceptable 2025-04-07
|
2025-04-15 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-22 | 2025-05-16 | Norway | Acceptable 2025-06-30
|
2025-07-01 |
| 25 | SUBSTANTIAL MODIFICATION | SM-25 | 2025-08-21 | Norway | Acceptable 2025-09-24
|
2025-09-24 |
| 26 | SUBSTANTIAL MODIFICATION | SM-26 | 2025-10-16 | Norway | Acceptable 2025-12-01
|
2025-12-02 |
| 27 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2026-04-14 | Norway | Acceptable 2025-12-01
|
2026-04-14 |