Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
133
Countries
7
Sites
40
B-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphoma
The primary objectives of the study are to characterize the safety, toxicity and tolerability profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of epcoritamab when co-administered with anti-neoplastic agen…
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Jun 2022 → ongoing
- Decision date (initial)
- 2024-02-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2023-505347-38-00
- EudraCT number
- 2021-005725-24
- ClinicalTrials.gov
- NCT05283720
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Dose response, Pharmacogenomic, Pharmacodynamic, Pharmacogenetic, Efficacy
The primary objectives of the study are to characterize the safety, toxicity and tolerability profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL.
Secondary objectives 2
- To evaluate the anti-NHL activity of epcoritamab when given in combination with anti-neoplastic agents in subjects with B-cell NHL.
- To characterize the pharmacokinetics of epcoritamab when given in combination with anti-neoplastic agents in subjects with B-cell NHL.
Conditions and MedDRA coding
B-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10025320 | Lymphomas non-Hodgkin's B-cell | 10029104 |
| 21.0 | PT | 10003903 | B-cell lymphoma refractory | 100000004864 |
| 21.0 | PT | 10012822 | Diffuse large B-cell lymphoma refractory | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult male or female, at least 18 years old
- (Arms 1, 2, 3, and 4) Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to WHO 2016 classification and documented in pathology report: DLBCL, not otherwise specified (NOS) - High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per World Health Organization (WHO) 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible - FL Grade 3B OR FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR MCL with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or PCR
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2, except for Arms 6, 7 and 8where ECOG performance status must be 0-1
- Subject must have 1 or more measurable disease sites: A positron emission tomography/computed tomography (PET/CT) scan demonstrating PET-positive lesion(s) AND - At least 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI
Exclusion criteria 2
- Diagnosis of High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL)
- Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.
Secondary endpoints 2
- Best overall response (BOR) by Lugano 2014 criteria as assessed by investigator for epcoritamab in combination with other antineoplastic agents.
- Antilymphoma activity of epcoritamab in combination with other antineoplastic agents: - Duration of response determined per Lugano 2014 criteria as assessed by investigator. - Progression free survival determined per Lugano 2014 criteria as assessed by investigator. - Complete response during the study determined per Lugano 2014 criteria as assessed by investigator. - Time to response determined per Lugano 2014 criteria as assessed by investigator. - Time to next antilymphoma therapy.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 20
Polivy 30 mg powder for concentrate for solution for infusion.
PRD8520648 · Product
- Active substance
- Polatuzumab Vedotin
- Substance synonyms
- RO5541077
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01FX14 — -
- Marketing authorisation
- EU/1/19/1388/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD367939 · Product
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- 8454.01.00
- MA holder
- MERCK HEALTHCARE GERMANY GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD367940 · Product
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- 8454.00.00
- MA holder
- MERCK HEALTHCARE GERMANY GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cyclophosphamide Injection 500 mg.
PRD347229 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- PL 00116/0387
- MA holder
- BAXTER HEALTHCARE LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB215610 · Substance
- Active substance
- Pirtobrutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Adriblastin® 50 mg Stechampulle
PRD411434 · Product
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- 1-20167
- MA holder
- PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10556500 · Product
- Active substance
- Epcoritamab
- Substance synonyms
- Anti-CD3E x Anti-MS4A1 IgG1 monoclonal antibody, Anti-(CD3 epsilon) and anti-(membrane-spanning 4-domains subfamily A member 1) IgG1 monoclonal antibody, GEN3013
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2581
PRD10556501 · Product
- Active substance
- Epcoritamab
- Substance synonyms
- Anti-CD3E x Anti-MS4A1 IgG1 monoclonal antibody, Anti-(CD3 epsilon) and anti-(membrane-spanning 4-domains subfamily A member 1) IgG1 monoclonal antibody, GEN3013
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2581
PRD9264311 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- 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
- No
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- 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
- No
PRD9264292 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- 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
- No
PRD9264267 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- 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
- No
PRD2186234 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD2186235 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD2186236 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
IMBRUVICA 140 mg hard capsules
PRD1729393 · Product
- Active substance
- Ibrutinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01EL01 — -
- Marketing authorisation
- EU/1/14/945/002
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMBRUVICA 140 mg hard capsules
PRD1729387 · Product
- Active substance
- Ibrutinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01EL01 — -
- Marketing authorisation
- EU/1/14/945/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 100 mg concentrate for solution for infusion
PRD5065907 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/002
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 500 mg concentrate for solution for infusion
PRD4797328 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/001
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD7515218 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| Medical Equipment Supplies And Management Limited ORG-100044212
|
Chorley, United Kingdom | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Cerba Research ORG-100042694
|
Gent, Belgium | Laboratory analysis |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Labcorp ORG-100011514
|
Burlington, United States | Laboratory analysis |
Locations
7 EU/EEA countries · 40 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 5 | 4 |
| Denmark | Ongoing, recruiting | 1 | 2 |
| France | Ongoing, recruiting | 14 | 10 |
| Germany | Ongoing, recruiting | 1 | 6 |
| Hungary | Ongoing, recruiting | 4 | 4 |
| Netherlands | Ongoing, recruiting | 5 | 4 |
| Spain | Ongoing, recruiting | 29 | 10 |
| Rest of world
Japan, Israel, United Kingdom, Taiwan, Canada, United States, China, Korea, Republic of
|
— | 74 | — |
Investigational sites
Fakultni Nemocnice Brno
NA, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Hradec Kralove
NA, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Ostrava
NA, 17. Listopadu 1790/5, 708 00, Poruba
Vseobecna Fakultni Nemocnice V Praze
NA, U Nemocnice 499/2, Nove Mesto, Prague 2
Region Midtjylland
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
Department of Hematology, Moelleparkvej 4, 9000, Aalborg
CHRU De Nancy
NA, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
University Hospital Of Clermont-Ferrand
NA, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire De Lille
NA, Rue Michel Polonowski, 59000, Lille
Institut Universitaire Du Cancer Toulouse-Oncopole
NA, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Rennes
NA, 2 Rue Henri Le Guilloux, 35000, Rennes
Assistance Publique Hopitaux De Paris
NA, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Hopital Saint Louis
NA, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Lyon Sud
NA, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
University Hospitals Pitie Salpetriere Charles Foix
NA, 47 To 83 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Universitaire De Nantes
NA, 1 Place Alexis Ricordeau, 44000, Nantes
Universitaetsklinikum Ulm AöR
NA, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Augsburg
NA, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Wuerzburg AöR
NA, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaet Leipzig
NA, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Philipps-Universitaet Marburg
NA, Baldingerstrasse, 35043, Marburg
Universitaetsklinikum Regensburg
NA, Franz-Josef-Straus-Allee 11, Gras-Oberisling, Ratisbon
University Of Debrecen
NA, Nagyerdei Korut 98, 4032, Debrecen
Semmelweis University
NA, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Orszagos Onkologiai Intezet
NA, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Somogy Varmegyei Kaposi Mor Oktato Korhaz
NA, Tallian Gyula Utca 20-32, 7400, Kaposvar
Universitair Medisch Centrum Groningen
NA, Hanzeplein 1, 9713 GZ, Groningen
Amsterdam UMC
NA, De Boelelaan 1117, 1081 HV, Amsterdam
University Hospital Maastricht
NA, P Debyelaan 25, 6229 HX, Maastricht
Academisch Ziekenhuis Leiden
NA, Albinusdreef 2, 2333 ZA, Leiden
Clinica Universidad De Navarra
NA, Calle Marquesado De Santa Marta 1, 28027, Madrid
Institut Catala D'oncologia
NA, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Institut Catala D'oncologia
NA, Carretera Canyet S/n, 08916, Badalona
Hospital Clinico Universitario De Valencia
NA, Avenida Blasco Ibanez 17, 46010, Valencia
Clinica Universidad De Navarra
NA, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
NA, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario De Salamanca
NA, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitari Vall D Hebron
NA, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Virgen Del Rocio S.L.
NA, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
NA, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| Czechia | 2022-12-19 | 2023-01-25 | |||
| Denmark | 2023-01-24 | 2023-12-12 | |||
| France | 2022-11-08 | 2022-12-19 | |||
| Germany | 2023-11-15 | 2025-08-01 | |||
| Hungary | 2023-06-09 | 2023-06-28 | |||
| Netherlands | 2022-11-22 | 2022-11-28 | |||
| Spain | 2022-06-13 | 2022-06-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 153 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_M22-132-protocol-Public Redacted | 7.0 |
| Protocol (for publication) | D4_Patient ID Card Arm 1 | 3.2 |
| Protocol (for publication) | D4_Patient ID Card Arm 2 | 3.2 |
| Protocol (for publication) | D4_Patient ID Card Arm 3 | 3.2 |
| Protocol (for publication) | D4_Patient ID Card Arm 3 and 3B | 4.0 |
| Protocol (for publication) | D4_Patient ID Card Arm 4 | 1.2 |
| Protocol (for publication) | D4_Patient ID Card Arm 5 | 1.2 |
| Protocol (for publication) | D4_Patient ID Card Arm 6A | 1.2 |
| Protocol (for publication) | D4_Patient ID Card Arm 6B | 1.2 |
| Protocol (for publication) | D4_Patient ID Card Arm 7 | 1.2 |
| Protocol (for publication) | D4_Patient ID Card Arm 8 | 1.1 |
| Recruitment arrangements (for publication) | EU-CTR blank document final | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document final | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document final | 1 |
| Recruitment arrangements (for publication) | K1 M22-132 FR Recruitment and ICF Procedures Public | 1 |
| Recruitment arrangements (for publication) | K1_M22-132 ES Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_M22-132 EU CTR Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | K1_M22-132 EU CTR Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M22-132_DE_Recruitment and ICF procedures_public | 1 |
| Recruitment arrangements (for publication) | K1_M22-132_NL_Recruitment and ICF Procedures_Public | 1.1 |
| Recruitment arrangements (for publication) | K2 M22-132 CZ Recruitment Brochure_Public | 3.0 |
| Recruitment arrangements (for publication) | K2 M22-132 DE Ad and Recruitment German MS Caregiver Booklet | 3.2 |
| Recruitment arrangements (for publication) | K2_M22-132 ES EPCORE Patient Downloadable Study Guide_SPA_Public | 3.2 |
| Recruitment arrangements (for publication) | K2_M22-132 ES EPCORE Patient-Doctor Discussion Guide_SPA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M22-132 ES EPCORE program level website - Website Copy_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-132 ES EPCORE Website Copy_SPA_Public | 3.2 |
| Recruitment arrangements (for publication) | K2_M22-132 HU Recruitment Brochure_Public | 3.2 |
| Recruitment arrangements (for publication) | K2_M22-132_DE_Recruitment Brochure_public | 3.3 |
| Recruitment arrangements (for publication) | K2_M22-132_NL_Recruitment Material Brochure_Public | 3.7 |
| Subject information and informed consent form (for publication) | L1 M22-132 CZ ICF PPA public | 2 |
| Subject information and informed consent form (for publication) | L1 M22-132 CZ Main ICF_Arm4_public | 4 |
| Subject information and informed consent form (for publication) | L1 M22-132 CZ Optional ICF_public | 4 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR ICF Addendum All Arms - French _Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm 1_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm 2_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm 4_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm 5_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm 6A_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm 6B_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm 7_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm 8_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M22-132 FR Main ICF French Arm3_Arm3B_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ Main ICF_Arm 2_public | 6 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ Main ICF_Arm 5_public | 4 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ Main ICF_Arm 6a_public | 4 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ Main ICF_Arm 6b_public | 3 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ Main ICF_Arm 8_public | 2 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ_GDPR ICF_public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ_ICF Main Arm 1_Public | 6 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ_ICF Main Arm 3 and 3B_public | 6 |
| Subject information and informed consent form (for publication) | L1 M22-132_CZ_ICF Main Arm 7_public | 3 |
| Subject information and informed consent form (for publication) | L1_M22-132 _DE_ICF Main ARM5_public redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 DK Main ICF Arm 1_public | 6.1 |
| Subject information and informed consent form (for publication) | L1_M22-132 DK Main ICF Arm 2_public | 6.1 |
| Subject information and informed consent form (for publication) | L1_M22-132 DK Main ICF Arm 3 and 3B_public | 6.1 |
| Subject information and informed consent form (for publication) | L1_M22-132 DK Main ICF Arm 4_public | 4.1 |
| Subject information and informed consent form (for publication) | L1_M22-132 DK Main ICF Arm 5_public | 4.1 |
| Subject information and informed consent form (for publication) | L1_M22-132 DK Main ICF Arm 6a_public | 4.1 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 1_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 2_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 3_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 3B_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 4_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 5_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 6A_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 6B_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 7_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Main ICF arm 8_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Optional ICF arms 1-3-3B-4 and 5_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Optional ICF arms 2 and 6A_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 ES Pregnant partner ICF_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 1_Public Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 2_Public Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 3 and 3B_Public Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 4_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 5_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 6A_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 6B_Public Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 7_Public Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Main ARM 8_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-132 HU PIS_ICF Pregnant Partner_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF Main ARM1_public redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF Main ARM2_public redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF Main ARM3 and 3B_public redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF Main ARM4_public redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF Main ARM6A_public redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF Main ARM6B_public redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF Main ARM7_public redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF Main ARM8_public redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF_BMS Pat Info Sheet Arm 4_5_public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_DE_ICF_Pregnant Partner_public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_HU_Mandatory Genetic ICF_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_HU_Mandatory Genetic PIS_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_HU_Optional Genetic ICF_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_HU_Optional Genetic PIS_Public Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_NL_ICF Main Arm 1_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_NL_ICF Main Arm 2_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_NL_ICF Main Arm 4_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_NL_ICF Main Arm 5_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_NL_ICF Main Arm 6A_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-132_NL_ICF Main Arm 6B_Public | 3.2 |
| Subject information and informed consent form (for publication) | L1_M22-132_NL_ICF Main Arm 8_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_M22-132_NL_ICF pregnant partner_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2 M22-132 CZ Info Given to Patient_Public | 5.0 |
| Subject information and informed consent form (for publication) | L2 M22-132 CZ PPP Public | 6 |
| Subject information and informed consent form (for publication) | L2 M22-132 FR Info Given to Subjects_Public | 6.0 |
| Subject information and informed consent form (for publication) | L2_ M22-132 DK Info Given to Subjects_Public | 3 |
| Subject information and informed consent form (for publication) | L2_M22-132 BMS Pregnancy Prevention Plan for Arms 4 and 5_Public | 5.0 |
| Subject information and informed consent form (for publication) | L2_M22-132 ES BMS PPP Patient Information Sheet for Arms 4 and 5_Public | 6.0 |
| Subject information and informed consent form (for publication) | L2_M22-132 HU_Subject participation Card_ARM8_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_M22-132_HU_Patient ID Card_Blank_Public | 1 |
| Subject information and informed consent form (for publication) | L2_M22-132_HU_PPP Patient Information for Arm 4_5_Public | 6.0 |
| Subject information and informed consent form (for publication) | L2_M22-132_NL_Other subject information material Pregnancy prevention plan_Public | 6.0 |
| Subject information and informed consent form (for publication) | L3 M22-132 -PPP Golcadomide BMS-986369 for sites | 5 |
| Subject information and informed consent form (for publication) | M22-132 CZE Main ICF Arm 1_for ongoing patients_Public | 3.1 |
| Subject information and informed consent form (for publication) | M22-132 CZE Main ICF Arm 2_for ongoing patient_Public | 3.1 |
| Subject information and informed consent form (for publication) | M22-132 CZE Main ICF Arm 3_for ongoing patients_Public | 3.1 |
| Subject information and informed consent form (for publication) | M22-132 ES ICF optional arm 1-4-5 - public | 2 |
| Subject information and informed consent form (for publication) | M22-132 Power of Attorney Main ICF_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_FRA_ICF Optional_public | 2 |
| Subject information and informed consent form (for publication) | M22-132_FRA_ICF Pregnant Partner_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 1 MAIN ICF_public | 2 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 1 MAIN_PIS_public | 2 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 2 MAIN ICF_public | 2 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 2 MAIN PIS_ public | 2 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 3 MAIN ICF_ public | 2 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 3 MAIN PIS_ public | 2 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 4 Main ICF_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 4 Main PIS_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 5 Main ICF_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 5 Main PIS_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 6A Main ICF_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 6A Main PIS_ public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 6B Main ICF_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 6B Main PIS_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 7 Main ICF_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_ARM 7 Main PIS_public | 1 |
| Subject information and informed consent form (for publication) | M22-132_HU_Pregnant Partner ICF_ public | 1.1 |
| Subject information and informed consent form (for publication) | M22-132_HU_Pregnant Partner PIS_ public | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_M22-132_Polatuzumab_SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_jaypirca-Pirtobutinib_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Prednisolone20MgTablets | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | EPAR_Revlimid 5 20 25MgHardCapsules | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | EPAR_Truxima100 500MgConcentrateForSolutionForInfusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_CyclophosphamideInjection500Mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Doxorubicin2MgMlSolutionForInjection | 2 |
| Synopsis of the protocol (for publication) | D1_M22-132 Danish Protocol Addendum Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m22-132-EU CTR-synopsis_CS-CZ | 1 |
| Synopsis of the protocol (for publication) | D1_m22-132-EU CTR-synopsis_EN | 1 |
| Synopsis of the protocol (for publication) | D1_m22-132-EU CTR-synopsis_ES-ES | 1 |
| Synopsis of the protocol (for publication) | D1_m22-132-EU CTR-synopsis_FR-FR | 1 |
| Synopsis of the protocol (for publication) | D1_m22-132-EU CTR-synopsis_HU-HU | 1 |
| Synopsis of the protocol (for publication) | D1_m22-132-EU CTR-synopsis_NL-NL | 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-30 | Spain | Acceptable 2024-02-05
|
2024-02-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-20 | Acceptable 2024-02-05
|
2024-02-20 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-21 | Spain | Acceptable 2024-11-13
|
2024-11-13 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-03 | Acceptable 2024-11-13
|
2024-12-03 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-04 | Spain | Acceptable 2025-06-25
|
2025-06-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-08 | Spain | Acceptable 2025-11-07
|
2025-11-10 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-21 | Acceptable 2025-11-07
|
2025-11-21 |