Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
35
Countries
5
Sites
5
Relapsed or refractory AL amyloidosis
To evaluate the efficacy of blmf in patients with relapsed or refractory AL amyloidosis.
Key facts
- Sponsor
- European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 1 Mar 2021 → 17 Jul 2025
- Decision date (initial)
- 2024-08-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- GlaxoSmithKline Research and Development Ltd
External identifiers
- EU CT number
- 2024-513075-40-00
- EudraCT number
- 2020-004001-32
- ClinicalTrials.gov
- NCT04617925
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy, Pharmacokinetic
To evaluate the efficacy of blmf in patients with relapsed or refractory AL amyloidosis.
Secondary objectives 3
- 1.The safety of blmf in patients with relapsed or refractory AL amyloidosis. a.Rates of AEs grade 3 or higher, related to blmf therapy b.Rates of treatment discontinuation due to toxicity related to blmf c.Dose reduction due to toxicity of blmf therapy d.Any grade hematologic AEs e.Any grade non-hematologic AEs f.Rates of AEs of special interest
- 2.Secondary efficacy evaluations: a.Overall hematologic response rates b.Organ response rates per individual organ c.Time to first hematologic response d.Time to at least a very good hematologic response e.Time to at least a low-dFLC response f.Duration of hematologic response (time from first response to hematologic progression, for those who achieved at least a hematologic PR or low-dFLC response) g.Time to a subsequent therapy, either due to progression or inadequate response h.Time to hematologic progression or major organ deterioration or death i.Overall survival j.Quality of life
- 3. Characterization of the blmf PK profile
Conditions and MedDRA coding
Relapsed or refractory AL amyloidosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10002022 | Amyloidosis | 100000004870 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Phase The Screening Phase begins when the first screening procedure is conducted. During the Screening Phase, eligibility criteria will be reviewed and a complete clinical evaluation will be performed as specified in the Time and Event Schedule (Table 1). Screening procedures will normally be performed within 28 days before Cycle 1, Day 1. For patients requiring mass spectrometry typing, the screening period is extended to 42 days. During Screening, a pregnancy test must be performed within 72 hours prior to the first dose for WOCBP. Results from skeletal survey obtained within 42 days before Cycle 1, Day 1 and bone marrow aspirate/biopsy obtained within a maximum of 56 days before Cycle 1, Day 1 may be used without repetition of these tests. If laboratory tests are performed within 5 days before Cycle 1, Day 1, it is not mandatory to collect these samples again at the Cycle 1, Day 1 visit before administration of trial treatment. Ocular examinations and procedures as described in Section 12.8 should be performed. If approved by the sponsor, patients who are screen failures may be rescreened if their condition changes. Patients who are determined eligible for rescreening must sign a new ICF.
- Histopathological diagnosis of amyloidosis
Tissue Specimens: based on the detection of homogenous amorphous, eosinophilic, hyaline-like, extracellular (subepithelial) material (by light microscopy of a H&E stained biopsy (4-6µ thick sections) and concomitant Congo red staining (orangophillic/eosinophillic under bright light; apple green birefringence under polarized light [4-6µ thick sections]) followed by immunohistochemical confirmation.
Immunohistochemistry (IHC): Suggested antibodies for IHC evaluation include:
• Kappa light chain (monoclonal/ in situ hybridization or IHC)
• Lambda light chain (monoclonal/ in situ hybridization or IHC)
• Amyloid A (monoclonal)
• Transthyretin (polyclonal) (* should be negative in AL Amyloidosis)
• Amyloid P component (polyclonal)
• antihuman β amyloid (polyclonal)
• a-hu β2 microglobulin (polyclonal)
• Fibrinogen (polyclonal)
• Lysozyme (polyclonal)
Electron microscopy appearance: unbranched 10 nm thick fibrils
Mass Spectrometry Typing of Amyloid as AL ((Liquid Chromatography-Tandem Mass Spectrometry [LC-MS/MS]):
For male patients over 70 years of age who have cardiac involvement only, and patients of African descent (black patients), a mass spectrometry, immunoelectron microscopy, or other immunohistochemistry-based typing of amyloid as AL or a negative bone scintigraphy with Tc99m-PYP or –DPD in a tissue biopsy is recommended to rule out age-related amyloid and/or hereditary amyloid (ATTR mutation). Mass spectrometry typing will be performed at a central laboratory. Processes for collection and transmission to the central vendor can be found in the Lab Manual for the trial.
- Factor X Deficiency
Patients with AL Amyloidosis may develop acquired Factor X deficiency30. Testing coagulation parameters and Factor X levels for all patients is recommended, but not required. Any clinically excessive bleeding should prompt testing for acquired Factor X level and supportive therapy including factor replacement if needed.
|
2 | None | ||
| 2 | Treatment phase Due to limitation in the number of the characters, for the complete description of the Treatment Phase, please refer to the trial protocol.
|
2 | None | ||
| 3 | Post-Treatment Observation Phase and Long-Term Follow-up For patients who discontinue trial treatment, disease evaluations should continue to be performed in the Post-Treatment Observation Phase as specified in the Time and Events Schedule (Table 1). Patients will be instructed that trial drug will not be made available to them after they have completed/discontinued trial treatment and that they should return to their primary physician to determine standard of care.
Patients with confirmed disease progression according to the defined criteria and those who discontinue therapy in Section 11.9 & 11.10 will enter the Long-term Follow-up Phase. Ocular examinations and procedures as described in Section 12.8 should be performed.
Subsequent anticancer treatment, response to subsequent treatment, and date of progression will be recorded, and survival status will be obtained. Information on secondary malignancies will also be collected. If the information is obtained via telephone contact, then written documentation of the communication must be available for review in the source documents. If the patient has died, then the date and cause of death will be collected and documented on the eCRF.
|
2 | None |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2019-001138-32 | A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study belantamab mafodotin (GSK2857916) as monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) – DREAMM 5, Estudio de plataforma de fase I/II, aleatorizado, abierto que utiliza el protocolo maestro para el estudio de belantamab mafodotin (GSK2857916) en monoterapia y en combinación con tratamientos contra el cáncer en participantes con mieloma múltiple en recaída/refractario (MMRR) – DREAMM 5., Randomizowane, prowadzone metodą otwartej próby badanie platformowe fazy I/II, oparte na protokole głównym, oceniające belantamab mafodotin (GSK2857916) stosowany w monoterapii i w połączeniu z lekami przeciwnowotworowymi u pacjentów z nawrotowym/opornym na leczenie szpiczakiem mnogim (RRMM) – DREAMM5, Randomizowane, prowadzone metodą otwartej próby badanie platformowe fazy I/II, oparte na protokole głównym, oceniające belantamab mafodotin (GSK2857916) stosowany w monoterapii i w połączeniu z lekami przeciwnowotworowymi u pacjentów z nawrotowym/opornym na leczenie szpiczakiem mnogim (RRMM) – DREAMM5, Randomizowane, prowadzone metodą otwartej próby badanie platformowe fazy I/II, oparte na protokole głównym, oceniające belantamab mafodotin (GSK2857916) stosowany w monoterapii i w połączeniu z lekami przeciwnowotworowymi u pacjentów z nawrotowym/opornym na leczenie szpiczakiem mnogim (RRMM) – DREAMM5, Randomizowane, prowadzone metodą otwartej próby badanie platformowe fazy I/II, oparte na protokole głównym, oceniające belantamab mafodotin (GSK2857916) stosowany w monoterapii i w połączeniu z lekami przeciwnowotworowymi u pacjentów z nawrotowym/opornym na leczenie szpiczakiem mnogim (RRMM) – DREAMM5, Randomizovaná, nezaslepená platformová studie fáze I/II využívající hlavní protokol ke studiu belantamab mafodotinu (GSK2857916) jako monoterapie a v kombinaci s protinádorovou léčbou u pacientů s relabujícím/refrakterním mnohočetným myelomem (RRMM) – DREAMM5, Randomizovaná, nezaslepená platformová studie fáze I/II využívající hlavní protokol ke studiu belantamab mafodotinu (GSK2857916) jako monoterapie a v kombinaci s protinádorovou léčbou u pacientů s relabujícím/refrakterním mnohočetným myelomem (RRMM) – DREAMM5 | |
| 2023-510537-28-00 | DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma | Glaxosmithkline Research & Development Limited |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- 1.Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry, or if not available, for patients with biopsy confirmed amyloidosis and cardiac involvement alone, if they also have a negative PYP- or DPD-Tc99m bone scan.
- 2.Patients must have had at least two cycles of therapy directed against plasma cell clone. However, patients that have received high dose therapy with melphalan as their only therapy are also eligible.
- 3.Patients must be 18 years of age or above
- 4.ECOG performance status 0, 1 or 2.
- 5.Mayo stage 1 or Mayo stage 2 or Mayo stage 3A1-3 defined as both cTnT < 0.035 ng/mL (or in place of cTnT the cTnI < 0.10 ng/mL or high sensitivity Troponin T < 54 ng/L) AND simultaneous NT-proBNP ≤ 332 ng/L, OR EITHER above threshold, or BOTH above threshold but with NTproBNP < 8500 ng/L (stage 3A disease)
- 6.Supine systolic blood pressure ≥ 90 mmHg.
- 7.Measurable disease defined by at least one of the following: a.serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L). b.presence of a monoclonal spike that is ≥0.5 g/dl.
- 8.Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
- 9. Patients must have adequate organ function.
- 10.Written informed consent in accordance with local and institutional guidelines.
- 11.Female patients: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a.She is not of childbearing potential (WOCBP) OR b.She is a WOCBP and using, during the intervention period and for at least 4 months after the last dose of the trial, a contraceptive method that is highly effective (failure rate <1% per year), preferably with low user dependency (as described in Appendix 3). Patient agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of trial intervention. A WOCBP must have a negative highly sensitive serum-pregnancy test (as required by local regulations) 72 hours before the first dose of the trial intervention. The investigator is responsible for reviewing the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Nonchildbearing potential is defined as follows (by other than medical reasons): a.≥45 years of age and has not had menses for >1 year b.Patients who have been amenorrhoeic for <2 years without a history of hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range after screening evaluation c.Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
- 12. Male patients: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male patients are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of trial treatment to allow for clearance of any altered sperm: a.Refrain from donating sperm PLUS, either: b.Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR c.Must agree to use contraception/barrier as detailed below: Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner agrees to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a woman of childbearing potential who is not pregnant.
- 13. All toxicities related to previous treatment (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCICTCAE], version 5, corneal toxicities are defined according to the Keratopathy Visual Activity [KVA] scale), must be ≤ Grade 1 at the time of enrolment except for alopecia.
- 14. Patient must be able to understand the trial procedures and agree to participate in the trial by providing written informed consent.
Exclusion criteria 26
- 1.Presence of non-AL amyloidosis.
- 2.Presence of lytic bone lesions or active myeloma with hypercalcemia, cast nephropathy, anemia due to marrow infiltration or extramedullary disease > 60% plasma cells in bone marrow.
- 3.Previous exposure to anti-BCMA agents.
- 4.Cardiac stage IIIB disease: both cTnT > 0.035 ng/mL (or in place of cTnT the cTnI > 0.10 ng/mL or high sensitivity Troponin T > 54 ng/L) AND simultaneous NT-proBNP >8500 ng/L.
- 5.Known repetitive ventricular arrhythmias on 24h Holter Electrocardiograms (ECG) despite anti-arrhythmic treatment. Patient must not have evidence of cardiovascular risk including any of the following: •Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block. •History of myocardial infarction, acute coronary syndromes (including unstable or uncontrolled angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening. •Class III or IV heart failure as defined by the New York Heart Association functional classification system (NYHA, 1994). •Severe uncontrolled ventricular arrhythmias, sick sinus syndrome, electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities (unless patient has a pacemaker). •Uncontrolled hypertension or hypotension (i.e., supine SBP< 90 mmHg despite supportive therapy with midodrine)
- 6.Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to Cycle 1 Day 1.
- 7.Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to Cycle 1 Day 1.
- 8.Ongoing corneal epithelial disease except mild changes in corneal epithelium (mild punctate keratopathy).
- 9.Current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia (except due to related nephrotic syndrome), esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
- 10.Active renal condition (infection, requirement for dialysis or any other condition that could affect the patient's safety) unrelated to AL amyloidosis. Patients with isolated proteinuria resulting from AL are eligible, provided they fulfil other inclusion criteria.
- 11.Patient must not use contact lenses while participating in this trial.
- 12.Patient must not be simultaneously enrolled in any interventional clinical trial.
- 13.Use of an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, prior to the first dose of trial drug.
- 14.Plasmapheresis within seven days prior to the first dose of the trial treatment.
- 15.Treatment with a monoclonal antibody within 30 days prior to the first dose of the trial treatment. Serious conditions unrelated to AL, such as SARS-CoV-2, may be permitted but need to be discussed with the medical doctor and trial-site personnel.
- 16.Major surgery ≤ 4 weeks prior to initiating trial treatment.
- 17.Evidence of active mucosal or internal bleeding
- 18.Known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to blmf or drugs chemically related to blmf, or any of the components of the trial treatment.
- 19.Active infection requiring treatment.
- 20.Known HIV infection (defined as positive testing for human immunodeficiency virus [HIV] antibodies).
- 21.Positive test for hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of trial treatment.
- 22.Positive test for hepatitis C antibody hepatitis C RNA at screening or within 3 months prior to the first dose of the trial treatment.
- 23.Invasive malignancies other than the disease under trial, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of the clinical trial treatments of the currently targeted malignancy. Patients with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
- 24.Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with the patient's safety, informed consent or compliance to the trial procedures.
- 25.Patients must not be pregnant or breast-feeding.
- 26.Participant must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary end point of the trial is the CR/VGPR/low-dFLC response rate at 6 months/ 4 cycles from start of therapy with blmf, according to consensus response criteria
Secondary endpoints 3
- Evaluation of safety (grade 3 or higher adverse events rates related to blmf therapy, treatment discontinuation rates, any grade hematologic adverse events, any grade non-hematologic adverse events)
- The limitation in the number of characters in this section does not allow to enter the endpoint. Please refer to the trial protocol
- Derived PK parameter values for belantamab mafodotin as data permit
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD6002468 · Product
- Active substance
- Belantamab Mafodotin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/kg milligram(s)/kilogram
- Max total dose
- 0 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
European Myeloma Network B.V.
- Sponsor organisation
- European Myeloma Network B.V.
- Address
- Blaak 555
- City
- Rotterdam
- Postcode
- 3011 GB
- Country
- Netherlands
Scientific contact point
- Organisation
- European Myeloma Network B.V.
- Contact name
- Efstathios Kastritis
Public contact point
- Organisation
- European Myeloma Network B.V.
- Contact name
- Pieter Sonneveld
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Health Data Specialists Consulting Services Organization And Conduct Of Studies Single Member S.A. ORG-100042969
|
Athens, Greece | On site monitoring, Code 12 |
| Health Data Specialists Ireland Limited ORG-100050864
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 5, Data management, E-data capture, Code 8 |
| Alliance Pharma Inc. ORG-100046000
|
Malvern, United States | Laboratory analysis |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) ORG-100008976
|
Rotterdam, Netherlands | Laboratory analysis |
| Almac Clinical Services (Ireland) Limited ORG-100033336
|
Dundalk, Ireland | Code 14 |
| National And Kapodistrian University Of Athens ORG-100009078
|
Athens, Greece | Laboratory analysis |
| Nicotian Haemodiagnosi Med E.E. ORG-100052169
|
Athens, Greece | Other, Laboratory analysis |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Code 14 |
| Syneos Health Inc. ORG-100008382
|
Princeton, United States | Laboratory analysis |
| Genotypos Private Diagnostic Laboratory Of Molecular And Cytogenetic Analysis S.A. ORG-100051295
|
Athens, Greece | Laboratory analysis |
Emn Trial Office S.r.l. Impresa Sociale
- Sponsor organisation
- Emn Trial Office S.r.l. Impresa Sociale
- Address
- Via Saluzzo 1/a, TO
- City
- Turin
- Postcode
- 10125
- Country
- Italy
Scientific contact point
- Organisation
- Emn Trial Office S.r.l. Impresa Sociale
- Contact name
- Mario Boccadoro
Public contact point
- Organisation
- Emn Trial Office S.r.l. Impresa Sociale
- Contact name
- Mario Boccadoro
Sponsor responsibilities
- Article 77 compliance
- European Myeloma Network B.V.
- Contact point sponsor
- European Myeloma Network B.V.
- Article 77 implementation
- European Myeloma Network B.V.
Locations
5 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 3 | 1 |
| Germany | Ended | 5 | 1 |
| Greece | Ended | 15 | 1 |
| Italy | Ended | 8 | 1 |
| Netherlands | Ended | 2 | 1 |
| Rest of world
United Kingdom
|
— | 2 | — |
Investigational sites
Centre Hospitalier Et Universitaire De Limoges
Service d'Hematologie Clinique et Therapie Cellulaire, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik und Poliklinik V Hematology, Oncology and Rheumatology Amyloidosis Clinic, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Alexandra Hospital
Department of Clinical Therapeutics, National & Kapodistrian University of Athens School of Medicine, Vassilissas Sofias Avenue 80, 115 28, Athens
Fondazione IRCCS Policlinico San Matteo
UOC Ematologia 1, Viale Camillo Golgi 19, 27100, Pavia
Universitair Medisch Centrum Utrecht
UMC Utrecht Cancer Center, MS Hematologie, Heidelberglaan 100, 3584 CX, Utrecht
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 |
|---|---|---|---|---|---|
| France | 2021-09-28 | 2025-06-24 | 2021-09-28 | 2023-06-27 | |
| Germany | 2021-08-18 | 2025-07-17 | 2021-08-18 | 2023-06-27 | |
| Greece | 2021-03-01 | 2025-07-01 | 2021-03-01 | 2023-06-27 | |
| Italy | 2021-12-26 | 2025-06-24 | 2021-12-26 | 2023-06-27 | |
| Netherlands | 2022-06-27 | 2025-04-18 | 2022-06-27 | 2023-06-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 49 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D2_Protocol modification nr 1_2024-513075-40_redacted | 5.0 |
| Protocol (for publication) | D2_Protocol modification nr 1_2024-513075-40_redacted_GR_EL | 5.0 |
| Protocol (for publication) | D4_Patient facing documents EORTC-QLQ-C30_DE | 3.0 |
| Protocol (for publication) | D4_Patient facing documents EORTC-QLQ-C30_EL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents EORTC-QLQ-C30_EN | 3.0 |
| Protocol (for publication) | D4_Patient facing documents EORTC-QLQ-C30_FR | 3.0 |
| Protocol (for publication) | D4_Patient facing documents EORTC-QLQ-C30_IT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents EORTC-QLQ-C30_NL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L_redacted | 1.2 |
| Protocol (for publication) | D4_Patient facing documents Patient Card_DE | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card_EL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card_EN | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card_FR | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card_IT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card_NL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents SF-36v2_redacted | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL_EN | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_placeholder document | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_placeholder document | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_placeholder document | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_placeholder document | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and Future Research ICF_DE_DE_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Data Privacy_IT_IT_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Withdrawal_DE_DE_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Withdrawal_FR_FR_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Withdrawal_IT_IT_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DE_DE_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_FR_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_EL_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_IT_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_NL_redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OFR Withdrawal_GR_EL redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OFR_GR_EL_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Patient Withdrawal_GR_EL_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_NL_NL_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP-PS Withdrawal_GR_EL_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP-PS_GR_EL_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Withdrawal_FR_FR_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_DE_DE_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_FR_FR_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_IT_IT_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner Withdrawal_DE_DE_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner Withdrawal_IT_IT_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE 2024-513075-40_DE_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2024-513075-40_EN_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2024-513075-40_FR_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis GR 2024-513075-40_EL_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2024-513075-40_IT_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-513075-40_NL_redacted | 5.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-11 | Italy | Acceptable 2024-08-20
|
2024-08-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-22 | Italy | Acceptable 2025-01-21
|
2025-01-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-28 | Italy | Acceptable 2025-05-05
|
2025-05-05 |