Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
606
Countries
10
Sites
57
Cancer - Plasma cell myeloma recurrent
- Demonstrate the efficacy non-inferiority between isatuximab subcutaneous (SC) and isatuximab intravenous (IV) in combination with pomalidomide and dexamethasone (Pd) - Demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Nov 2022 → ongoing
- Decision date (initial)
- 2024-05-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508869-32-00
- EudraCT number
- 2021-002485-41
- WHO UTN
- U1111-1261-5846
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacokinetic
- Demonstrate the efficacy non-inferiority between isatuximab subcutaneous (SC) and
isatuximab intravenous (IV) in combination with pomalidomide and dexamethasone (Pd)
- Demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd
Secondary objectives 11
- Assess efficacy of isatuximab SC compared to isatuximab IV in combination with Pd
- Demonstrate the PK non-inferiority between isatuximab SC and isatuximab IV in combination with Pd
- Assess safety of isatuximab SC and IV in combination with Pd
- Assess participant’s satisfaction with isatuximab SC and IV
- Assess efficacy of isatuximab SC compared to isatuximab IV in combination with Pd
- Assess safety of isatuximab SC and IV and local tolerability of isatuximab SC in combination with Pd
- Characterize PK of isatuximab SC and IV in combination with Pd
- Assess the delivery performance of the (investigational) device injector
- Assess the potential immunogenicity of isatuximab SC and IV in combination with Pd
- Assess the clinical outcome of isatuximab SC and IV in combination with Pd
- Explore chromosomal abnormalities (mainly but not limited to t(4;14), t(14;16), del(17p), and 1q21+), and potential association with clinical outcomes
Conditions and MedDRA coding
Cancer - Plasma cell myeloma recurrent
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073133 | Plasma cell myeloma recurrent | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- -Participants with multiple myeloma who have received at least one prior line of anti- myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
- -Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)).
Exclusion criteria 11
- -Primary refractory multiple myeloma participants
- -Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
- -Prior therapy with pomalidomide
- Participants with inadequate biological tests.
- -Significant cardiac dysfunction
- - Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
- -Concomitant plasma cell leukemia
- -Active primary amyloid light -chain amyloidosis
- -Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
- -Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
- -Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Overall response rate (ORR)
- Observed concentration before dosing (Cthrough) at steady state
Secondary endpoints 24
- Very Good Partial Response or better rate (VGPR
- Observed concentration before dosing (Ctrough)
- Incidence rate of infusion-reactions
- Percentage of participants satisfied or very satisfied with the injection method used to administer study medication
- Duration of response (DOR)
- Time to first response (TT1R)
- Time to best response (TTBR)
- Progression free survival (PFS)
- Overall survival (OS)
- Progression free survival 2 (PFS2)
- Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)
- Pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)
- PK parameter: Area under the plasma concentration time curve over the dosing period (AUC)
- Successful injection rate
- Percentage of participants with anti-drug antibodies (ADA) against isatuximab
- Participant expectation questionnaire-baseline (PEQ-BL) score
- Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score
- Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score
- Patient’s Assessment of Treatment (PAT) questionnaire score
- Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores
- Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score
- Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20)
- Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores
- Number of participants with chromosomal abnormalities
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 21
PRD9260804 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9260814 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9260810 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9260806 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9260813 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9260809 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/005
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9260808 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9260805 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD988427 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 12800 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.02.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 12800 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
Pomalidomide Adalvo 1 mg hard capsules
PRD11984093 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- MA1339/02201
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Adalvo 3 mg hard capsules
PRD11984095 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- MA1339/02203
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Adalvo 2 mg hard capsules
PRD11984094 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- MA1339/02202
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Adalvo 4 mg hard capsules
PRD11984096 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- MA1339/02204
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10652636 · Product
- Active substance
- Isatuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 226800 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10653334 · Product
- Active substance
- Isatuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 226800 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10978287 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10978237 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10978187 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10978182 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10653408 · Product
- Active substance
- Isatuximab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1400 mg milligram(s)
- Max total dose
- 226800 mg milligram(s)
- Max treatment duration
- 80 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 2
SCP1139557 · ATC
- Active substance
- Montelukast Sodium
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R03DC03 — MONTELUKAST
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- 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
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 82 Avenue Raspail
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Third parties 18
| Organisation | City, country | Duties |
|---|---|---|
| ESMS Global Limited ORG-100023149
|
London, United Kingdom | Other |
| ApoEx AB ORG-100021830
|
Stockholm, Sweden | Code 14 |
| Centrala Farmaceutyczna Cefarm S.A. ORG-100019105
|
Radomsko, Poland | Code 14 |
| Centrala Farmaceutyczna Cefarm S.A. ORG-100019105
|
Warsaw, Poland | Code 14 |
| Keosys ORG-100048982
|
St Herblain, France | Other |
| PetMobile Kft. ORG-100047817
|
Budakalasz, Hungary | Code 14 |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Code 14 |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Depo-pack S.r.l. ORG-100013780
|
Saronno, Italy | Code 14 |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Labcorp Early Development Laboratories Limited ORG-100011365
|
Harrogate, United Kingdom | Laboratory analysis |
| Bioiatriki Private Medical Polyclinic S.A. ORG-100047061
|
Athens, Greece | Laboratory analysis |
| Vaestra Goetalandsregionen ORG-100040070
|
Goteborg, Sweden | Code 14 |
| Pharmalink Sp. z o.o. ORG-100019134
|
Lodz, Poland | Code 14 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Endpoint Clinical Inc. ORG-100040567
|
San Francisco, United States | Interactive response technologies (IRT) |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
Locations
10 EU/EEA countries · 57 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 44 | 4 |
| France | Ongoing, recruitment ended | 17 | 9 |
| Germany | Ongoing, recruitment ended | 12 | 4 |
| Greece | Ongoing, recruitment ended | 25 | 5 |
| Hungary | Ongoing, recruitment ended | 25 | 9 |
| Italy | Ongoing, recruitment ended | 15 | 9 |
| Norway | Ongoing, recruitment ended | 14 | 2 |
| Poland | Ongoing, recruitment ended | 23 | 4 |
| Spain | Ongoing, recruitment ended | 35 | 7 |
| Sweden | Ongoing, recruitment ended | 7 | 4 |
| Rest of world
Brazil, China, Australia, Chile, Canada, United States, Argentina, Turkey, Japan, United Kingdom, Taiwan
|
— | 389 | — |
Investigational sites
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika, U Nemocnice 499/2, Nove Mesto, Prague
University Hospital Olomouc
Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika FN Brno a LF MU, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Centre Leon Berard
Hématologie Cancérologie Médicale, 28 Rue Laennec, 69008, Lyon
Hospices Civils De Lyon
Service Hematologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Regional Universitaire De Tours
Hématologie Cancérologie Médicale, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier De Perigueux
Service Oncologie-Hématologie, 80 Avenue Georges Pompidou, 24000, Perigueux
Centre Hospitalier Universitaire De Nantes
Service d'Hematologie, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Service d'hématologie et thérapie cellulaire, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Toulouse
Service d'hématologie et thérapie cellulaire, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Poitiers
Oncologie Médicale, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Saint Etienne
Département d'Hématologie et Thérapie Cellulaire, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Universitaetsklinikum Heidelberg AöR
Innere Medizin V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Schleswig-Holstein AöR
Hamatologie/Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Klinikum Nuernberg
Hamatologie/Onkologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Technische Universitaet Dresden
Hamatologie/Onkologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University General Hospital Of Ioannina
Hematology clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
General University Hospital Of Patras
Hematology clinic-Bone Marrow Transplantation Unit, Rio, 265 04, Patras
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hemmatology clinic, Exochi, 570 10, Thessaloniki
Evaggelismos Hospital
Hematology clinic, Ipsiladou 45-47, 106 76, Athens
Alexandra Hospital
Hematology- Oncology Section, Dept of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Semmelweis University
Belgyogyaszati es Haematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
University Of Pecs
I.sz. Belgyogyaszati Klinika, Hematologiai Tanszek, Rakoczi Ut 2, 7623, Pecs
University Of Pecs
I. sz. Belgyógyászati Klinika, Ifjusag Utja 13, 7624, Pecs
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Belgyogyaszat - III. Belgyogyaszat, Hematologiai Osztaly, Seregelyesi Ut 3, 8000, Szekesfehervar
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Belgyogyaszat - III. Belgyogyaszat, Hematologiai Osztaly, Seregelyesi Ut 3, 8000, Szekesfehervar
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Hematologiai es Ossejt-transzplantacios Osztaly, Albert Florian Ut 5-7, 1097, Budapest IX
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Haematologiai Osztaly, Tallian Gyula Utca 20-32, 7400, Kaposvar
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Haematologiai és Haemosztazeologiai Osztaly, Markusovszky Str. 5, 9700, Szombathely
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità Operativa Complessa Servizio e DH di Ematologia, Largo Agostino Gemelli 8, 00168, Rome
Fondazione IRCCS Policlinico San Matteo
U.O. Ematologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Delle Marche
SOD Clinica Ematologica, Via Conca 71, 60126, Ancona
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Federico II Di Napoli
U.O.C Ematologia, Via Sergio Pansini 5, 80131, Naples
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
U.O. Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Operativa Complessa di Ematologia, Via Del Vespro 129, 90127, Palermo
Helse Moere Og Romsdal HF
Department of Clinical and Molecular Medicine Department of Health Sciences Ålesund, Aasehaugen 5, 6017, Aalesund
Oslo University Hospital HF
Poliklinikk, Blodsykdommer bygn 20, P. O. Box 4950, 0424, Oslo
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Hematologii i Chorób Wewnętrznych, Ul. Mikolaja Kopernika 36, 31-501, Cracow
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematoonkologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 16, 20-081, Lublin
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddzial Hematologiczny, Ul. Grabiszynska 105, 53-439, Wroclaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Borowska 213, 50-556, Wroclaw
Hospital Universitario Marques De Valdecilla
Servicio de Hematologia, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Ramon Y Cajal
UTMO (Unidad de trasplante de médula osea), Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Clinical Hospital Virgen De La Arrixaca
Servicio de Hematologia, Carretera De Cartagena Sn, El Palmar, Murcia
Institut Catala D'oncologia
Institut Català d'Oncologia - Institut de Recerca Josep Carreras, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario La Paz
Servicio de Hematologia, Paseo Castellana 261, 28046, Madrid
Clinica Universidad De Navarra
Servicio de Hematologia, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario De Salamanca
Servicio de Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca
Karolinska University Hospital
Hematologi Mottagning, Halsovagen, Flemingsberg, Huddinge
Soedersjukhuset AB
Hematologimottagningen, Sjukhusbacken 10, Hogalid, Stockholm
Karolinska University Hospital
Hematologi Mottagning, Halsovagen, Flemingsberg, Huddinge
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Hematologi- och onkologiavdelning, Bramhultsvagen 53, Boras Gustav Adolf, Boras
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 |
|---|---|---|---|---|---|
| Czechia | 2023-06-05 | 2023-06-05 | 2024-04-11 | ||
| France | 2023-03-07 | 2023-03-07 | 2024-04-11 | ||
| Germany | 2023-07-27 | 2023-07-27 | 2024-04-11 | ||
| Greece | 2022-11-10 | 2022-11-10 | 2024-04-11 | ||
| Hungary | 2023-02-27 | 2023-02-27 | 2024-04-11 | ||
| Italy | 2023-07-03 | 2023-07-03 | 2024-04-11 | ||
| Norway | 2023-08-08 | 2023-08-08 | 2024-04-11 | ||
| Poland | 2023-03-22 | 2023-03-22 | 2024-04-11 | ||
| Spain | 2022-11-29 | 2022-11-29 | 2024-04-11 | ||
| Sweden | 2023-06-07 | 2023-06-07 | 2024-04-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 133 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1-rdct clinical investigational plan-el-2023-508869-32 | 6 |
| Protocol (for publication) | d1-rdct-clinical investigation plan-en-2023-508869-32 | 6 |
| Protocol (for publication) | d1-rdct-protocol-el-2023-508869-32 | 4 |
| Protocol (for publication) | d1-rdct-protocol-en-2023-508869-32 | 4 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-cs-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-de-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-el-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-en-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-es-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-fr-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-hu-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-it-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-HRUPQ-sv-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-list for publication-en-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PAT-de-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PAT-el-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PAT-en-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PAT-es-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PAT-fr-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PAT-sv-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PATv2-hu-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEBQL-cs-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQ-BL-es-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQ-PESQ-BL-el-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQ-PESQ-BL-sv-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQ-PESQ-EOT-el-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQ-PESQ-EOT-es-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQ-PESQ-EOT-sv-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQ-PESQ-FU-el-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQ-PESQ-FU-sv-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQBL-de-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQBL-en-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQBL-fr-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQBL-hu-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PEQBL-it-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQ-EOT-hu-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQEOT-cs-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQEOT-de-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQEOT-en-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQEOT-fr-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQEOT-it-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQFU-cs-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQFU-de-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQFU-en-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQFU-es-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQFU-fr-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQFU-hu-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PESQFU-it-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLT-el-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLT-es-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLT-sv-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLTQ-cs-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLTQ-de-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLTQ-en-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLTQ-fr-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLTQ-hu-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PLTQ-it-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-cs-2023-508869-32 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-it-2023-508869-32 | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangement-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangement-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangement-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-waiver-en | 1 |
| Recruitment arrangements (for publication) | TR_Placeholder Transparency document | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-activities-no | 7 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-fr | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-adult-no | 9 |
| Subject information and informed consent form (for publication) | L1-sis-icf-biobanking-de | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-data-processing-hu | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-data-processing-pregnant-partner-hu | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-dataprotection-de | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-device-hu | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-fu-pregnancy-no | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-use-of-samples-cs | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-use-research-it | 4.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-gdpr-pl | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-general-data-protection-regulation-cs | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-genetic-hu | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-hiv-test-de | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-homecare-VFN-cs | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-addendum2-fr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-cs | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-de | 7 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-el | 4.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-es | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-fr | 3.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-hu | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-it | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-pl | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-sv | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-medical-device-cs | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-direct-to-patient-el | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-future-use-el | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-home-nurse-el | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-participant-child-fu-fr | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-cs | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-de | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-el | 3.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-es | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-father-fr | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-fr | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-it | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-no | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-pl | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-sv | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-ppp-1-de | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-ppp-2a-de | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-ppp-2b-de | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-ppp-3-de | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnant-partner-hu | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-it | 4.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-site-specific-addendum-semmelweis -hu | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-gpletter-it | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-memo-sponsor-address-de | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-dexamethasone-uk-smpc-advanz | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-Imnovid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-Imnovid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-Imnovid | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-cs-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-el-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-en-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-es-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-hu-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-it-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-no-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pl-2023-508869-32 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-sv-2023-508869-32 | 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-12 | Spain | Acceptable 2024-05-14
|
2024-05-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-15 | Spain | Acceptable 2024-05-14
|
2024-08-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-11 | Spain | Acceptable 2025-02-18
|
2025-02-18 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-13 | Spain | Acceptable 2025-02-18
|
2025-03-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-27 | Acceptable | 2025-10-09 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-15 | Spain | Acceptable 2026-03-03
|
2026-03-04 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-15 | Spain | Acceptable 2026-03-03
|
2026-05-15 |