Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
400
Countries
8
Sites
50
Relapsed/Refractory Follicular Lymphoma
To evaluate the efficacy of Golca + R vs Investigator’s choice (IC) in participants with Relapsed/Refractory Follicular Lymphoma (R/R FL) with respect to progression-free survival (PFS-IRAC)
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 3 Sep 2025 → ongoing
- Decision date (initial)
- 2025-07-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Celgene Corporation
External identifiers
- EU CT number
- 2024-519152-82-00
- WHO UTN
- U1111-1314-3909
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy
To evaluate the efficacy of Golca + R vs Investigator’s choice (IC) in participants with Relapsed/Refractory Follicular Lymphoma (R/R FL) with respect to progression-free survival (PFS-IRAC)
Secondary objectives 11
- To evaluate the overall response Rate (ORR) as determined by an independent group of experts: how many participants' lymphoma shrinks or disappears.
- To evaluate the Overall Survival (OS): the amount of time from when the study starts until the person passes away from any cause.
- To evaluate the Progression-Free Survival (PFS) as determined by the treating physician.
- To evaluate the Overall Response Rate (ORR) as determined by the treating physician.
- To evaluate the Complete Metabolic Response (CMR) as determined by the treating physician: at the end of the treatment, the person's body shows no signs of the cancer when we do tests.
- To evaluate the Duration of Response (DoR): how long the treatment keeps the disease under control.
- To evaluate the Event Free Survival (EFS): the amount of time from when the study starts until the cancer gets worse or the person passes away from any cause or starts a new anti-lymphoma treatment or the tumor becomes more aggressive, whichever happens first.
- To evaluate the time to Next Anti-lymphoma Treatment (TTNT): the amount of time from when the study starts until the initiation of a new anti-lymphoma treatment or the person passes away from any cause, whichever happens first.
- To evaluate the Progression-Free Survival on next anti-lymphoma treatment (PFS2): the amount of time from when the study starts until the cancer gets worse after a new anti-lymphoma treatment or the person passes away from any cause, whichever happens first.
- To evaluate the MRD negativity: how treatment can completely remove any trace of cancer in the blood by the end of the treatment. This is done by looking for undetectable levels of cancer DNA in the blood.
- To compare participants' experiences with symptoms, daily functioning, and quality of life on both treatments.
Conditions and MedDRA coding
Relapsed/Refractory Follicular Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10085128 | Follicular lymphoma | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-510178-15-00 | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants with Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1) | Celgene Corp. |
| 2024-511304-16-00 | A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination with Rituximab in Patients with Newly Diagnosed Advanced Stage Follicular Lymphoma | Celgene Corp. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants over the age of 18
- Participants meeting all inclusion criteria including disease characteristics, laboratory values and reproductive capacity status would be considered eligible.
Exclusion criteria 3
- Participants cannot participate to the study if they have medical conditions or physical and laboratory test results incompatible with participation in the trial, such as significant medical disease, active infection, laboratory abnormality, incapacitating psychiatric illness
- Other lymphoma subtypes
- Specific allergies or adverse reactions to certain types of medication
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate time from randomization to the first disease progression based on Lugano 2014 classification guidelines as assessed by Independent Review Adjudication committee (IRAC) or death from any cause, whichever occurs earlier.
Secondary endpoints 5
- To evaluate how long a participant lives overall.
- To evaluate how well the cancer responds to the treatment.
- To evaluate how long the cancer responds.
- To evaluate how long it takes for participants to start a new treatment.
- To evaluate how the treatment impacts the quality of life of participants while they are taking it.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD11026428 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMADOC-360526170-162
PRD11026427 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMADOC-360526170-162
PRD11167270 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMADOC-360526170-162
PRD7515218 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMADOC-360526170-162
Comparator 15
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 168 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 1400 mg milligram(s)
- Max total dose
- 9800 mg milligram(s)
- Max treatment duration
- 168 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Betamethasone Sodium Phosphate
SCP107974752 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/square meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00696MIG · Substance
- Active substance
- Bendamustine Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 90 mg/m2 milligram(s)/square meter
- Max total dose
- 1080 mg/m2 milligram(s)/square meter
- Max treatment duration
- 168 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00696MIG · Substance
- Active substance
- Bendamustine Hydrochloride
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 90 mg/m2 milligram(s)/square meter
- Max total dose
- 1080 mg/m2 milligram(s)/square meter
- Max treatment duration
- 168 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be over-labeled and repackaged.
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 12 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
SUB16451MIG · Substance
- Active substance
- Pegfilgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Clario ORL-000001208
|
Princeton, United States | Other |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| QPS LLC ORG-100012847
|
Newark, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Cerba Research ORG-100042694
|
Gent, Belgium | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Accenture Services Pvt. Ltd. ORL-000000127
|
Bengaluru, India | Other |
| Endpoint Clinical Inc. ORL-000012879
|
Wakefield, United States | Other, Interactive response technologies (IRT) |
| Iqvia Inc. ORG-100010622
|
Durham, United States | On site monitoring, Code 10, Code 11, Code 12, Other, Code 2, Data management, Code 9 |
Locations
8 EU/EEA countries · 50 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 9 | 3 |
| France | Ongoing, recruiting | 20 | 8 |
| Germany | Ongoing, recruiting | 25 | 13 |
| Greece | Ongoing, recruiting | 15 | 5 |
| Italy | Ongoing, recruiting | 21 | 7 |
| Netherlands | Ongoing, recruiting | 9 | 3 |
| Poland | Ongoing, recruiting | 13 | 5 |
| Spain | Ongoing, recruiting | 18 | 6 |
| Rest of world
Korea, Republic of, Chile, India, China, Canada, Australia, Japan, Saudi Arabia, Turkey, United States, United Kingdom, United Arab Emirates, Brazil
|
— | 270 | — |
Investigational sites
Oulu University Hospital
Cancer centre, Kajaanintie 50, 90220, Oulu
HUS-Yhtymae
Comprehensive cancer center, Haartmaninkatu 4, 00290, Helsinki
Turku University Hospital
Department of Oncology and Radiotherapy, Oncology and hematology, Kiinamyllynkatu 4-8, 20520, Turku
Hospices Civils De Lyon
Hematologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Lille
Services des maladies du sang, Rue Michel Polonovski, 59037, Lille Cedex
Institut Curie
Oncologie, 35 Rue Dailly, 92210, Saint-Cloud
Centre Hospitalier Universitaire De Montpellier
Hematologie clinique, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Universitaire De Nantes
Hematologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Toulouse
Hematologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Hopital Saint Louis
Hemato-oncoloige, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Bordeaux
Hematologie clinique et therapie cellulaire, Avenue De Magellan, 33600, Pessac
HELIOS Klinikum Erfurt GmbH
4. Medizinische Klinik, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
Studienzentrum am Raschplatz
Onkologisches Studienzentrum, Rundestraße 10, 30161, Hannover
LMU Klinikum Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Gemeinschaftspraxis für Hämatologie und Onkologie Münster, Dueesbergweg 128, Dueesberg, Muenster
Universitaet Des Saarlandes
Klinik für Innere Medizin I, Kirrberger Strasse 100, 66421, Homburg
Klinikum Chemnitz gGmbH
Innere Medizin III, Flemmingstrasse 2, Altendorf, Chemnitz
Universitaetsklinikum Augsburg
II. Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH
Gemeinschaftspraxis für Hämatologie und Onkologie, Am Oelpfad 12, Hörde, Dortmund
Universitaetsklinikum Duesseldorf AöR
Klinik für Hämatologie, Onkologie und Klinische Immunilogie, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin II, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Ulm AöR
Institute of Experimental Cancer Research Comprehensive Cancer Center Ulm (CCCU), Albert-Einstein-Allee 11, Eselsberg, Ulm
Gemeinschaftspraxis Haematologie Onkologie
Onkologische Schwerpunktpraxis, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Laiko General Hospital Of Athens
Department of Clinical Trials, Haematology Clinic and Bone Marrow Transplantation Unit, Agiou Thoma (goudi) 17, 115 27, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department of Haematology, Exochi, 570 10, Thessaloniki
Evaggelismos Hospital
Hematology and Lymphoma Clinic, Ipsiladou 45-47, 106 76, Athens
University General Hospital Of Alexandroupoli
Haematology Division, Thalassemia Unit, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
University General Hospital Of Ioannina
Department of Haematology, Niarchou Stavrou Avenue, 455 00, Ioannina
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
dipartimento malattie oncologiche ed ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Humanitas Mirasole S.p.A.
UO Oncologia medica e Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
oncology, Corso Bramante 88, 10126, Turin
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
ematologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero Universitaria Pisana
Clinical and experimental medicine, Via Roma 67, 56126, Pisa
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
SCDU Ematolog ia, Via Venezia 16, 15121, Alexandria
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Ematologia Oncologia, Via Mariano Semmola 52, 80131, Naples
Amsterdam UMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Pratia S.A.
Pratia MCM Krakow, Ul. Pana Tadeusza 2, 30-727, Cracow
Szpitale Pomorskie Sp. z o.o.
Szpital Morski im. PCK Oddział Hematologii i Transplantologii Szpiku, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Aidport Sp. z o.o.
n/a, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Narodowy Instytut Onkologii i Traumatologii im. M. Kopernika w Lodzi
Oddział Hematoonkologii z Pododdziałem Chemioterapii Dziennej, ul. Pabianicka 62, 93-513, Lodz
Hospital Universitario Virgen De Las Nieves
Hematology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico Universitario De Valencia
Hematology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Parc Tauli Hospital Universitari
Hematology, Parc Del Tauli 1, 08208, Sabadell
Hospital Universitario Infanta Leonor
Hematology, Avenida Gran Via Del Este 80, 28031, 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 |
|---|---|---|---|---|---|
| Finland | 2025-10-13 | 2025-10-29 | |||
| France | 2025-09-04 | 2025-09-29 | |||
| Germany | 2025-09-03 | 2025-09-09 | |||
| Greece | 2025-10-09 | 2025-11-04 | |||
| Italy | 2025-09-03 | 2025-09-29 | |||
| Netherlands | 2025-09-08 | 2025-10-17 | |||
| Poland | 2025-09-05 | 2025-09-22 | |||
| Spain | 2025-09-05 | 2025-09-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 103 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CA073-1003__Statement on validated questionnaires under license_IT | 1 |
| Protocol (for publication) | D1_Protocol 2024-519152-82 redacted | Global 01 |
| Protocol (for publication) | D1_Protocol Administrative letter 2024-519152-82 redacted | N/A |
| Protocol (for publication) | D1_Protocol June 2025_EU CT 2024-519152-82_GR_Redacted | 01 EU |
| Protocol (for publication) | D1_Protocol_EU CT 2024-519152-82_GR_redacted | 01 |
| Protocol (for publication) | D4_patient facing documents__statement_under license PL | n/a |
| Protocol (for publication) | D4_Patient facing documents_All questionnaires_Statement_NL | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_FR | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_DE | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_EN | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_ES | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_GR | NA |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 2.0 |
| Recruitment arrangements (for publication) | K1 Template recruitment arrangements IT | 2 |
| Recruitment arrangements (for publication) | K1_FI_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_NL | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Brochure | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangement_DE_CA073-1003 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_Material_PI-to-Patient Letter | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_Material_Study Infographic | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_Material_Visit_Guide | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Patient Letter_GR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI-to-Patient Letter_PL | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_GR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_recruitment brochure_IT | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_New participants_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_ES | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_redacted_IT_ | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Redacted_ES | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional future research_redacted_IT_ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection 1_Redacted_ES | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection 2_Redacted_ES | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional sample collection_redacted_ IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_Future Research_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partecipant_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_Redacted_ES | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_GR_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted_ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF privacy notice_redacted_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement redacted_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_clean_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_clean_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NL_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NL_Polish Translation certificate | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_NL_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_NL_Polish Translation certificate | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_NL_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_NL_Polish Translation certificate | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Samples Collection C1D8_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Samples Collection Progression_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional_Sample_clean_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_NL_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_NL_Polish Translation certificate | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_NL_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_NL_Polish Translation certificate | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_clean_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_clean_DE_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF-Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_PPP Golcadomide Section 5_ES | 6 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_PPP Lenalidomide Section 5_ES | 4 |
| Subject information and informed consent form (for publication) | L2_FI_Other subject info_Golcadomide_PPP | 6 |
| Subject information and informed consent form (for publication) | L2_FI_Other subject info_Len_PPP | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_Golcadomide Information Sheet_FR | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_Lenalidomide Information Sheet_FR | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Golcadomide PPP_GR | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Lenalidomide PPP_GR | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material PPP Golcadomide_PL | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material PPP Lenalidomide_PL | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material pregnancy prevention plan country translation_Golcadomide_IT | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material pregnancy prevention plan country translation_Lenalidomide_IT | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PPP Golcadomide_NL | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PPP Lenalidomide_NL | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject Information material_Pregnancy Prevention Plan_Golcadomide_DE | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject Information material_Pregnancy Prevention Plan_Lenalidomide_DE_ | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide_summary of changes | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519152-82_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-519152-82-00_EN | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-519152-82-00_EN track change | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519152-82-00_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU CT 2024-519152-82_ES | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU CT 2024-519152-82_FR | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU CT 2024-519152-82_GR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2024-519152-82_NL | 2.0 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-28 | Finland | Acceptable 2025-07-17
|
2025-07-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-29 | Acceptable 2025-07-17
|
2025-07-29 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-30 | Acceptable 2025-07-17
|
2025-07-30 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-30 | Acceptable 2025-07-17
|
2025-07-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-31 | Acceptable | 2025-08-15 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-18 | 2025-08-18 | ||
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-08-18 | Finland | 2025-08-18 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-08-27 | 2025-08-27 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-01 | Acceptable | 2025-09-08 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-04 | Finland | Acceptable 2026-03-12
|
2026-03-12 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-03-27 | Acceptable 2026-03-12
|
2026-03-27 |