Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
517
Countries
11
Sites
47
Cancer
To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Dec 2017 → ongoing
- Decision date (initial)
- 2024-09-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514417-34-00
- EudraCT number
- 2017-002238-21
- WHO UTN
- U1111-1194-2121
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Pharmacokinetic, Efficacy, Therapy
To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.
Secondary objectives 13
- To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: -Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. -Minimal residual disease (MRD) negativity rate in participants with CR. -Very good partial response or better rate, as defined by the IMWG criteria. -Overall survival (OS).
- To evaluate the overall response rate (ORR) as per IMWG criteria.
- To evaluate the time to progression (TTP) overall and by MRD status.
- To evaluate PFS by MRD status.
- To evaluate the duration of response (DOR) overall and by MRD status.
- To evaluate time to first response (TT1R).
- To evaluate time to best response (TTBR).
- To evaluate progression-free survival on next line of therapy (PFS2).
- To evaluate the sustained MRD negativity >12 months rate.
- To evaluate safety.
- To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only).
- To evaluate the immunogenicity of isatuximab in participants receiving isatuximab (IVRd and crossover arms).
- To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
Conditions and MedDRA coding
Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10035226 | Plasma cell myeloma | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-002205-PIP01-17
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- -Multiple myeloma (International Myeloma Working Group [IMWG] criteria).
- -Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or participants < 65 years with comorbidities impacting possibility of transplant.
- -Evidence of measurable disease.
- -Written informed consent
Exclusion criteria 8
- -Age <18 years.
- -Prior treatment for multiple myeloma.
- -Any other prior or ongoing disease/health conditions incompatible with the study objectives.
- -Organ function values not met.
- -Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) > 2.
- -Hypersensitivity to the study medications.
- -Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
- -Male participants who disagree to follow the study contraceptive counseling.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression free survival (PFS)
Secondary endpoints 18
- Complete response (CR)
- Minimal residual disease (MRD) negativity rate for participants with CR
- Very good partial response (VGPR) or better rate
- Overall survival (OS)
- Overall response rate (ORR)
- Time to progression (TTP)
- Duration of response (DOR)
- Time to first response (TT1R)
- Time to best response (TTBR)
- PFS on next line of therapy (PFS2)
- PFS in MRD negative participants
- Sustained MRD negativity ≥12 months rate
- Adverse Events
- Assessment of PK parameter: Ctrough
- Immunogenicity
- Participants reported outcome (PRO): QLQ-C30
- PRO: QLQ-MY20
- PRO: EQ-5D-5L
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 20
Dexamethasone 3.3 mg/ml solution for injection
PRD302046 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 202160 mg milligram(s)
- Max treatment duration
- 115 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 01502 /0079
- MA holder
- HAMELN PHARMA LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
VELCADE 3.5 mg powder for solution for injection
PRD3349073 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1.3 mg/m3 milligram(s)/cubic meter
- Max total dose
- 91.52 mg milligram(s)
- Max treatment duration
- 168 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8721724 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00505
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD8721744 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00507
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD8721704 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00504
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD8721743 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00506
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD8721745 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00502
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264271 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/004
- 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
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(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
- Repackaging and relabeling for clinical supplies
PRD9264307 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/013
- 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
PRD9264287 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/008
- 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
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(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
- Repackaging and relabeling for clinical supplies
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(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
- Repackaging and relabeling for clinical supplies
PRD9264292 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/010
- 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
PRD9264311 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/014
- 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
PRD9264288 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/011
- 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
PRD9264267 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 61075 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/009
- 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
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 540056 mg milligram(s)
- Max treatment duration
- 115 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD10653334 · Product
- Active substance
- Isatuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 99636 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 115 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
DexaGalen® 8 mg injekt Injektionslösung
PRD801335 · Product
- Active substance
- Dexamethasone Sodium Phosphate Ph. Eur.
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 202160 mg milligram(s)
- Max treatment duration
- 115 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 49345.01.00
- MA holder
- GALENPHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
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 22
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Early Development Laboratories Limited ORG-100011365
|
Harrogate, United Kingdom | Laboratory analysis |
| Pharmalink Sp. z o.o. ORG-100019134
|
Lodz, Poland | Code 14 |
| PHOENIX lekarensky velkoobchod s.r.o. ORG-100019669
|
Brno-Cernovice, Czechia | Code 14 |
| Logiters Logistica Portugal S.A. ORG-100014814
|
Azambuja, Portugal | Code 14 |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Laboratory analysis |
| Tamro AB ORG-100012530
|
Hisings Backa, Sweden | Code 14 |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Euraxi Pharma ORG-100028910
|
Joue Les Tours, France | Other |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Code 14 |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Teckro Limited ORG-100041454
|
Limerick, Ireland | Other |
| Zentiva k.s. ORG-100004108
|
Prague, Czechia | Code 14 |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Centrala Farmaceutyczna Cefarm S.A. ORG-100019105
|
Radomsko, Poland | Code 14 |
| Centrala Farmaceutyczna Cefarm S.A. ORG-100019105
|
Warsaw, Poland | Code 14 |
| Bioiatriki Private Medical Polyclinic S.A. ORG-100047061
|
Athens, Greece | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Code 14, Interactive response technologies (IRT) |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Signant Health Oy ORG-100045212
|
Helsinki, Finland | E-data capture |
| ESMS Global Limited ORG-100023149
|
London, United Kingdom | Other |
| Evidenze Portugal Unipessoal Lda. ORG-100042799
|
Alges, Portugal | Code 14 |
| Depo-pack S.r.l. ORG-100013780
|
Saronno, Italy | Code 14 |
Locations
11 EU/EEA countries · 47 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 55 | 6 |
| Denmark | Ongoing, recruitment ended | 9 | 3 |
| France | Ongoing, recruitment ended | 89 | 12 |
| Germany | Ongoing, recruitment ended | 21 | 4 |
| Greece | Ongoing, recruitment ended | 34 | 3 |
| Italy | Ongoing, recruitment ended | 19 | 4 |
| Lithuania | Ongoing, recruitment ended | 11 | 2 |
| Poland | Ongoing, recruitment ended | 24 | 3 |
| Portugal | Ongoing, recruitment ended | 23 | 4 |
| Spain | Ongoing, recruitment ended | 17 | 4 |
| Sweden | Ongoing, recruitment ended | 6 | 2 |
| Rest of world
China, Turkey, Mexico, United States, Taiwan, New Zealand, Russian Federation, Australia, Japan
|
— | 209 | — |
Investigational sites
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika - klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Hradec Kralove
IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
University Hospital Olomouc
Hemato-onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Plzen
Hematologicko-onkologicke oddeleni, Edvarda Benese 1128/13, Jizni Predmesti, Plzen 3
Aalborg University Hospital
Department of Haematology, Sdr, Søndre Skovvej 15, Aalborg
Odense University Hospital
Department of Haematology X, Kloevervaenget 47, 5000, Odense C
Aarhus Universitetshospital
Hematologisk afd., Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Departemental Vendee
Service onco hématologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Hopital Saint Antoine
Hématologie clinique et Therapie cellulaire, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Hospices Civils De Lyon
Service Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Poitiers
Hématologie et Therapie cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Dijon
Service d'Hématologie clinique, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Caen Normandie
Service Hématologie Clinique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier De La Cote Basque
Service Hématologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
CHRU De Nancy
Service Hématologie, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Oncopole Claudius Regaud
Service hématologie-médecine interne, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Lille
Departement hématologie, maladies du sang, Rue Michel Polonovski, 59037, Lille Cedex
Hospital Hotel Dieu
Departement hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Bordeaux
Hématologie clinique et Therapie cellulaire, Avenue De Magellan, 33600, Pessac
Universitaetsklinikum Frankfurt AöR
Medizinische Klinik II Abteilung Hämatologie und Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Tuebingen AöR
Hamatologie, Onkologie etc., Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
HELIOS Klinikum Berlin-Buch GmbH
Hamatologie/Onkiologie, Schwanebecker Chaussee 50, Buch, Berlin
Universitaetsklinikum Heidelberg AöR
Hämatologie, Onkologie und Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Alexandra Hospital
Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department - BMT Unit, Exochi, 570 10, Thessaloniki
Evangelismos S.A.
Department of Hematology and Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
Azienda Ospedaliero Universitaria Delle Marche
Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I( #1), Via Conca 71, 60126, Ancona
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dip di Med.Specialistica, Diagnostica e Sperimentale-Unita Operativa di Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Presidio Molinette, Corso Bramante 88, 10126, Turin
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
A.S.S.T Spedali Civili di Brescia( #1), Piazzale Spedali Civili 1, 25123, Brescia
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Hematology, Oncology and Transfusion Medicine Center, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Klaipedos universiteto ligonine VšĮ
Klaipeda Seamen's hospital( #1), Liepojos G. 45, Klaipedos M. Sav., Klaipeda
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Debinki 7, 80-952, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klin.Nowotworow Ukl. Chlonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Odział Hematologii Ogólnej i Chorób Wewnętrznych, Ul. Pabianicka 62, 93-513, Lodz
CCAB Centro Clinico Academico Braga Associacao
NA, Lugar De Sete Fontes S Victor, 4710-243, Braga
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
NA, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Coimbra E.P.E.
NA, Praceta Professor Mota Pinto, 3004-561, Coimbra
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Departamento de Hematologia, Rua Professor Lima Basto, 1099-023, Lisbon
Hospital General Universitario Morales Meseguer
Servicio de Hematología y Oncología Médica, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Vall D Hebron Institute Of Oncology
Servei d'Hematologia, Calle Natzaret 115, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Servicio de Hematología y Hemoterapia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De La Santa Creu I Sant Pau
Servei d'Hematologia, Carrer De San Quinti 89, 08041, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2017-12-14 | 2017-12-14 | 2019-06-17 | ||
| Denmark | 2018-04-16 | 2018-04-16 | 2019-06-17 | ||
| France | 2018-02-27 | 2018-02-27 | 2019-06-17 | ||
| Germany | 2018-05-15 | 2018-05-15 | 2019-06-17 | ||
| Greece | 2018-01-17 | 2018-01-17 | 2019-06-17 | ||
| Italy | 2018-04-18 | 2018-04-18 | 2019-06-17 | ||
| Lithuania | 2018-03-20 | 2018-03-20 | 2019-06-17 | ||
| Poland | 2018-07-16 | 2018-07-16 | 2019-06-17 | ||
| Portugal | 2018-04-23 | 2018-04-23 | 2019-06-17 | ||
| Spain | 2018-01-25 | 2018-01-25 | 2019-06-17 | ||
| Sweden | 2018-05-18 | 2018-05-18 | 2019-06-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 91 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1-rdct-protocol-el-2024-514417-34-00 | 8 |
| Protocol (for publication) | d1-rdct-protocol-en-2024-514417-34-00 | 8 |
| Protocol (for publication) | d4-patient-facing-material-list-for-publication-en-2024-514417-34 | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-1-to-main-cs | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-2-to-main-cs | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-3-to-main-cs | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-4-to-main-cs | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-5-fr | 1.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-5-to-main-cs | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum2-fr | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum3-fr | 1.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum4-fr | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum6-fr | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum7-fr | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-biobanking-de | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-research-cs | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-gdpr-cs | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-gdpr-pl | 4.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-citta-salute-it | 6.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-cs | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-da | 11 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-el | 8.1 |
| 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-lt | 11 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-riuniti-it | 6 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-sant-orsola-it | 6.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-site version-it | 9 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-spedali-civili-it | 6.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-sv | 12 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-dtp-el | 1.0 |
| 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-participant-child-fr | 2.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-child-fr | 1.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-citta-salute-it | 5.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-da | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-de | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-es | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-fr | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-it | 6 |
| 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-riuniti-it | 4.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-sant-orsola-it | 4.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-spedali-civili-it | 4.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-de | 10.2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-es | 8 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-it | 8 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-pl | 7 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-pt | 12.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnancy-pt | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnant-partner-cs | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnant-partner-el | 3.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-citta-salute-it | 4.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-ospedali-riuniti-it | 2.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-sant-orsola-it | 2.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-spedali-civili-it | 2.0 |
| Subject information and informed consent form (for publication) | L1-sis-partner-pregnancy-lt | 3 |
| Subject information and informed consent form (for publication) | L1-sis-partner-pregnancy-sv | 3 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-leaflet-da | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-memo-sponsor-address-change-de | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-ppp-part1-de | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-ppp-part2a-de | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-ppp-part2b-de | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-ppp-part3-de | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-release-from-confidentiality-de | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G1-smpc-bortezomib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1-smpc-comparator-lenalidomide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1-smpc-comparator-lenalidomide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1-smpc-dexamethasone iv | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1-smpc-dexamethasone iv | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G1-smpc-dexamethasone po | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-cs-2024-514417-34 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-el-2024-514417-34 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-en-2024-514417-34-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-es-2024-514417-34 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-2024-514417-34 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-it-2024-514417-34 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-lt-2024-514417-34 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pl-2024-514417-34 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pt-2024-514417-34 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-sv-2024-514417-34 | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-13 | Czechia | Acceptable 2024-09-19
|
2024-09-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-31 | Czechia | Acceptable 2025-05-07
|
2025-05-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-20 | Czechia | Acceptable 2026-02-16
|
2026-02-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-02 | Czechia | Acceptable | 2026-04-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-15 | Acceptable | 2026-04-22 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-04-27 | Acceptable | 2026-06-01 |