Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
831
Countries
11
Sites
94
Multiple Myeloma
The primary objective is to determine if the addition of daratumumab to VRd will prolong PFS defined as the time from the date of randomization to the date of disease progression (assessed by International Myeloma Working Group [IMWG] criteria) or death, compared with VRd alone.
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] - Neoplasms [C04]
- Trial duration
- 24 Dec 2018 → ongoing
- Decision date (initial)
- 2024-03-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development, LLC
External identifiers
- EU CT number
- 2023-506125-10-00
- EudraCT number
- 2018-002992-16
- ClinicalTrials.gov
- NCT03710603
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy, Pharmacodynamic, Pharmacogenomic, Pharmacokinetic
The primary objective is to determine if the addition of daratumumab to VRd will prolong PFS defined as the time from the date of randomization to the date of disease progression (assessed by International Myeloma Working Group [IMWG] criteria) or death, compared with VRd alone.
Secondary objectives 8
- To determine if the addition of daratumumab to VRd will improve clinical outcome as measured by: - MRD negativity rate post-consolidation and overall MRD negativity rate achieved at any time during the study - ORR, rate of VGPR or better, rate of CR or better, rate of sCR at post-induction, post transplant, post-consolidation, and overall - Time to response - Duration of response - Progression-free survival on the next line of therapy (PFS2) - OS
- To assess the safety profile of daratumumab+VRd (D-VRd)
- To evaluate pharmacokinetics (PK) of daratumumab
- To determine the immunogenicity of daratumumab and rHuPH20
- To evaluate patient-reported outcomes (PROs) and medical resource utilization (MRU)
- To evaluate stem cell yield after mobilization
- To evaluate time to engraftment post ASCT
- To evaluate the benefit/risk of stopping daratumumab upon sustained MRD negative status
Conditions and MedDRA coding
Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Phase (28 days) The Screening Phase will start up to 28 days before randomization.
|
Not Applicable | None | ||
| 2 | Treatment Phase (28-day cycles) The Treatment Phase will extend from Cycle 1 Day 1 to discontinuation of all study treatment. The Treatment Phase
will consist of six 28-day cycles, 4 cycles of induction, followed by ASCT, then 2 cycles of consolidation, followed by 28-day cycles of maintenance therapy until disease progression or unacceptable toxicity.
|
Randomised Controlled | None | Arm A: In Arm A, subjects will receive VRd for induction, followed by autologous stem cell transplantation, followed by VRd consolidation, followed by lenalidomide (R) maintenance until disease progression or unacceptable toxicity. Arm B: Subjects in Arm B will receive D-VRd for induction, followed by autologous stem cell transplantation, followed by D-VRd consolidation, followed by daratumumab and lenalidomide maintenance until disease progression or unacceptable toxicity. Subjects in Arm B who have a response of CR or better will stop therapy with daratumumab after sustained MRD negativity (at the threshold of 10^-5) for 12 months and after a minimum of 24 months of maintenance therapy. These subjects will continue lenalidomide maintenance therapy until disease progression or unacceptable toxicity. After stopping daratumumab therapy, subjects who previously stopped per protocol should restart therapy with daratumumab if there is a recurrence of MRD at 10^-4 or higher or a confirmed loss of CR without IMWG-defined disease progression as evidenced by the reappearance of serum or urine monoclonal protein (M-protein) by immunofixation or electrophoresis by central laboratory or development of ≥5% plasma cells in bone marrow. After reinitiating daratumumab, the subject will continue daratumumab and lenalidomide therapy until disease progression or unacceptable toxicity. Subjects in Arm B will receive D-VRd for induction, followed by autologous stem cell transplantation, followed by D-VRd consolidation, followed by daratumumab and lenalidomide maintenance until disease progression or unacceptable toxicity. Subjects in Arm B who have a response of CR or better will stop therapy with daratumumab after sustained MRD negativity (at the threshold of 10^-5) for 12 months and after a minimum of 24 months of maintenance therapy. These subjects will continue lenalidomide maintenance therapy until disease progression or unacceptable toxicity. After stopping daratumumab therapy, subjects with sustained MRD negativity should restart therapy with daratumumab if there is a recurrence of MRD at 10^-4 or higher or a confirmed loss of CR without IMWG-defined disease progression as evidenced by the reappearance of serum or urine monoclonal protein (M-protein) by immunofixation or electrophoresis by central laboratory or development of ≥5% plasma cells in bone marrow. After reinitiating daratumumab, the subject will continue daratumumab and lenalidomide therapy until disease progression or unacceptable toxicity. |
|
| 3 | Follow-up Phase Subjects will enter the Follow-up Phase once they experience documented disease progression or unacceptable toxicity leading to all study treatment discontinuation or if they have not achieved a response of PR or better by C7D1. In the Follow-up Phase, subjects who discontinued before disease progression must continue to have disease evaluations according to the Time and Events Schedule and should not initiate any subsequent anticancer treatment until confirmed disease progression. After disease progression is documented, follow-up will be obtained at least every 4 months ±2 weeks. Subsequent anticancer treatment, disease progression data (per investigator assessment) on the first line of subsequent therapy, new malignancies, PRO assessments, and survival status will also be recorded.
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- Danish Medicines Agency, European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 13
- 18 to 70 years of age, inclusive.
- Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria: CRAB criteria: 1. Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL) 2. Renal insufficiency: creatinine clearance <40mL/min or serum creatinine >177 μmol/L (>2 mg/dL) 3. Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL 4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT Biomarkers of Malignancy: a. Clonal bone marrow plasma cell percentage ≥60% b. Involved: uninvolved serum FLC ratio ≥100 c. >1 focal lesion on magnetic resonance imaging (MRI) studies
- Measurable disease as defined by any of the following: a. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or b. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin FLC ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
- Newly diagnosed subjects for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Attachment 1).
- Clinical laboratory values meeting the following criteria during the Screening Phase (screening hematology and chemistry tests should be repeated if done more than 3 days before C1D1): Adequate bone marrow function: a. Hemoglobin ≥7.5 g/dL (≥4.65 mmol/L; prior red blood cell [RBC] transfusion or recombinant human erythropoietin use is permitted however transfusions are not permitted within 7 days of randomization to achieve this minimum hemoglobin count); b. Absolute neutrophil count (ANC) ≥1.0 x 10^9/L (G-CSF use is permitted); c. Platelet count ≥50 x 10^9/L if bone marrow is >50% involved in myeloma. Otherwise ≥75 x 10^9/L Adequate liver function: a. Aspartate aminotransferase (AST) ≤2.5 x ULN; b. Alanine aminotransferase (ALT) ≤2.5 x ULN; c. Total bilirubin ≤1.5 x ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome, direct bilirubin ≤1.5 x ULN) Adequate renal function: a. Estimated creatinine clearance ≥30 mL/min. Creatinine clearance may be calculated using Cockcroft-Gault, eGFR (Modified Diet in Renal Disease [MDRD]; Attachment 2), or CKD-epi formula b. Corrected serum calcium ≤13.5 mg/dL (≤3.4 mmol/L); or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L) (see Attachment 3) NOTE: For Criteria 7-11, contraceptive (birth control) use by men or women should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for subjects in clinical studies.
- Criterion modified per Amendment 2. 7.1 Female subjects of reproductive childbearing potential (defined as post-menarche until post-menopause unless permanently sterilized) must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously during the treatment period, during any dose interruptions, and for 3 months after the last dose of any component of the treatment regimen. Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug and is consistent with the usual lifestyle of the subject. This birth control method must include one highly effective form of contraception (tubal ligation, intrauterine device [IUD], hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner’s vasectomy with confirmation of procedure) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.
- A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing. For requirements during the Treatment Phase, refer to Section 4.3.
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen.
- Male subjects of reproductive potential who are sexually active with females of reproductive potential must always use a latex or synthetic condom during the study and for 3 months after discontinuing study treatment (even after a successful vasectomy).
- Male subjects of reproductive potential must not donate sperm during the study or for 3 months after the last dose of study treatment.
- Criterion modified per Amendment 2 12.1 Signed an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Subjects in emergency situations that do not allow for collection of informed consent are excluded.
- Able to adhere to the prohibitions and restrictions specified in this protocol.
Exclusion criteria 21
- Prior or current systemic therapy or SCT for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.
- Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).
- Criterion modified per Amendment 2 4.1 Radiation therapy for treatment of plasmacytoma within 14 days of randomization (palliative radiation for pain control secondary to lytic lesion is allowed within 14 days of randomization).
- Plasmapheresis within 28 days of randomization.
- Clinical signs of meningeal involvement of multiple myeloma.
- Criterion modified per Amendment 2 7.1 Pulmonary: a. Subjects <65 years old with chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) <50% of predicted normal b. Subjects ≥65 years old with a FEV1 <50% or diffusing capacity of the lungs for carbon monoxide [DLCO] <50%
- Moderate or severe persistent asthma within the past 2 years (see Attachment 4), or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
- Criterion modified per Amendment 2 9.1 Criterion modified per Amendment 4 Any of the following: a. Known to be seropositive for human immunodeficiency virus (HIV). HIV antibody testing at screening should be performed per local health guidelines. b. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time PCR measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. c. Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
- Concurrent medical or psychiatric condition or disease (such as, but not limited to, systemic amyloidosis, POEMS, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
- Criterion modified per Amendment 2 11.1 Any of the following: a. myocardial infarction within 6 months before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV) b. uncontrolled cardiac arrhythmia c. screening 12-lead ECG showing a baseline QT interval >470 msec (exception: subjects with pacemaker) d. screening ECHO or MUGA scan for subjects aged >65-70: left ventricular ejection fraction (LVEF) <40%
- Received a strong CYP3A4 inducer within 5 half-lives prior to randomization (Flockhart 2016: http://medicine.iupui.edu/flockhart/)
- Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the Investigator's Brochure), or sensitivity to mammalian-derived products or lenalidomide or its excipients.
- Criterion modified per Amendment 2 14.1 Not able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder). Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Subject is taking any prohibited medications as per Section 8.3. Subject is deprived of their freedom by a judicial or administrative decision, or subject is in psychiatric care. Subject is subjected to a legal protection measure or unable to provide their consent.
- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen. Or, subject is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen.
- Major surgery within 2 weeks before randomization or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Kyphoplasty or Vertebroplasty is not considered major surgery.
- Criterion modified per Amendment 2 17.1 Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or 5 half-lives of the respective drug/investigational medicinal product (IMP) (whichever is longer) before randomization or is currently enrolled in an interventional investigational study.
- Contraindications to the use of any components of the backbone treatment regimens, per local prescribing information.
- Gastrointestinal disease that may significantly alter the absorption of oral drugs
- Vaccination with live attenuated vaccines within 4 weeks of first study agent administration
- Unable or unwilling to undergo antithrombotic prophylactic treatment. NOTE: Investigators should ensure that all study enrollment criteria have been met at screening. If a subject’s clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study drug is given such that he or she no longer meets all eligibility criteria, then the subject should be excluded from participation in the study. Section 17.4, Source Documentation, describes the required documentation to support meeting the enrollment criteria.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS is defined as the time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
Secondary endpoints 12
- Post-consolidation MRD negativity rate, defined as the proportion of subjects who achieve MRD negativity (at or below the threshold of 10^- 5) at the end of consolidation.
- Overall MRD negativity rate, defined as the proportion of subjects who achieve MRD negativity (10^-5) at any time during the study.
- Overall ORR, rate of VGPR or better, rate of CR or better, and rate of sCR, defined as the proportions of subjects who achieved PR or better (or VGPR or better, or CR or better, or sCR) per the IMWG criteria at post-induction, post-transplant, post-consolidation, and overall.
- Progression-free survival on the next line of therapy (PFS2) is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first.
- OS, measured from the date of from randomization to the date the subject's death.
- Time to response (PR or better), time to CR/sCR are defined as the time from randomization to date of initial response (or initial CR/sCR,).
- Duration of response (PR or better), duration of CR, duration of sCR, and duration of MRD-negative status, are calculated from the date of the initial documentation of a response (PR or better), or CR or better, or sCR, or MRD-negative status to the date of the first documented evidence of disease progression, as defined in the IMWG criteria, or death due to PD whichever occurs first.
- Pharmacokinetic concentrations of daratumumab (further defined in Section 9.3).
- Immunogenicity of daratumumab and rHuPH20
- Change in HRQoL, symptoms, and functioning using two European Organization for Research and Treatment of Cancer (EORTC) questionnaires and the EuroQol Group Five Dimensions Five Levels Questionnaires (EQ-5D-5L).
- Stem cell yield after mobilization (further defined in Section 9.1.3.2).
- Time to engraftment post ASCT defined as absolute neutrophil count (ANC) ≥0.5 x 10^9/L and platelet count ≥20 x 10^9/L.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 212.4 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
Auxiliary 11
SCP10332310 · ATC
- Active substance
- Dexamethasone Acetate
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 1.92 g gram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Mylan 5 mg hard capsules
PRD11828369 · Product
- Active substance
- Lenalidomide
- Substance synonyms
- 3-(7-AMINO-3-OXO-1H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione, CDC-501, SYP-1512, CC-5013
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/005
- MA holder
- MYLAN PHARMACEUTICALS LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Mylan 15 mg hard capsules
PRD11828376 · Product
- Active substance
- Lenalidomide
- Substance synonyms
- 3-(7-AMINO-3-OXO-1H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione, CDC-501, SYP-1512, CC-5013
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/012
- MA holder
- MYLAN PHARMACEUTICALS LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264287 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/008
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264292 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/010
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264288 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/011
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Mylan 10 mg hard capsules
PRD11828374 · Product
- Active substance
- Lenalidomide
- Substance synonyms
- 3-(7-AMINO-3-OXO-1H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione, CDC-501, SYP-1512, CC-5013
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45.57 g gram(s)
- Max treatment duration
- 109 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/010
- MA holder
- MYLAN PHARMACEUTICALS LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VELCADE 3.5 mg powder for solution for injection
PRD703624 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1.30 mg/m2 milligram(s)/square meter
- Max total dose
- 31.2 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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
- Professor Pieter Sonneveld
Public contact point
- Organisation
- European Myeloma Network B.V.
- Contact name
- Professor Pieter Sonneveld
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Stichting EuroQol Research Foundation ORG-100048809
|
Rotterdam, Netherlands | Other |
| SGS Belgium ORG-100007917
|
Mechelen, Belgium | Laboratory analysis |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Interactive response technologies (IRT) |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Vrilissia, Greece | On site monitoring |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Other |
| Eurofins Pharma Bioanalytics Services US Inc. ORG-100049364
|
Saint Charles, United States | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 12, Code 2, Interactive response technologies (IRT), Data management, Code 8, Code 9 |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other |
| Clinigen Clinical Supplies Management ORG-100034422
|
Mont-Saint-Guibert, Belgium | Other |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) ORG-100008976
|
Rotterdam, Netherlands | Other |
| Bioagilytix Labs LLC ORG-100013030
|
San Diego, United States | Other |
| European Organisation For Research And Treatment Of Cancer ORG-100010848
|
Sint-Lambrechts-Woluwe, Belgium | Other |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
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
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
11 EU/EEA countries · 94 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 15 | 3 |
| Czechia | Ongoing, recruitment ended | 35 | 2 |
| Denmark | Ongoing, recruitment ended | 20 | 5 |
| France | Ongoing, recruitment ended | 167 | 23 |
| Germany | Ongoing, recruitment ended | 40 | 2 |
| Greece | Ongoing, recruitment ended | 22 | 4 |
| Italy | Ongoing, recruitment ended | 140 | 24 |
| Netherlands | Ongoing, recruitment ended | 75 | 9 |
| Norway | Ongoing, recruitment ended | 15 | 1 |
| Poland | Ongoing, recruitment ended | 19 | 2 |
| Spain | Ongoing, recruitment ended | 140 | 19 |
| Rest of world
Turkey, Switzerland, Australia
|
— | 143 | — |
Investigational sites
Imelda
BE10003: Oncologie, Imeldalaan 9, 2820, Bonheiden
Het Ziekenhuisnetwerk Antwerpen
BE10002: Hematology, Kempenstraat 100, 2030, Antwerp
UZ Leuven
BE10001: Hematologie, Herestraat 49, 3000, Leuven
Fakultni Nemocnice Ostrava
CZ10003:Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Brno
CZ10002:Int. hemat. a onkol. klinika, Jihlavska 340/20, Bohunice, Brno
Odense University Hospital
DK10001: Hematology, J B Winsloews Vej 4, 5000, Odense C
Region Sjaelland
DK10003: Hematology, Sygehusvej 10, 4000, Roskilde
Rigshospitalet
DK10005: Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
Aalborg University Hospital
DK10004: Medical,Haematologic, Moelleparkvej 4, 9000, Aalborg
Region Midtjylland
DK10006: Blodsygdomme Klinisk Forskning, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Universitaire Amiens Picardie
FR10009:Service Hématologie Clinique et Thérapie Cellulaire, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Nantes
FR10016: Hematologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Caen Normandie
FR10008: Hématologie Clinique - IHBN, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Rennes
FR10021: Hématologie clinique, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Henri Becquerel
FR10024: Unité de Recherche Clinique, 1 Rue D Amiens, 76000, Rouen
Centre Hospitalier Universitaire De Lille
FR10023: Hematologie, Rue Michel Polonovski, 59037, Lille Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
FR10018: Hematologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Poitiers
FR10007: Service d’Hématologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Institut Curie
FR10026: Service Hématologie, 35 Rue Dailly, 92210, Saint-Cloud
Institut De Cancerologie Strasbourg Europe
FR10020: Hematology, 17 Rue Albert Calmette, 67200, Strasbourg
Centre Hospitalier Annecy Genevois
FR10022: Hematology, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Besancon University Hospital Center
FR10005: Hématologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Hopital Saint Louis
FR10001: Immunologie-Hematologie Clinique, 1 Avenue Claude Vellefaux, 75010, Paris
Hopital Saint Antoine
FR10019: Hématologie Et De Thérapie Cel, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Regional Et Universitaire De Brest
FR10004: Service d’Hématologie Clinique, 2 Avenue Marechal Foch, 29200, Brest
Centre Hospitalier Lyon Sud
FR10006: Immunologie clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Assistance Publique Hopitaux De Paris
FR10002: Hemopathies Lymphoides, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre Hospitalier Regional Universitaire De Tours
FR10003: Hématologie, 2 Boulevard Tonnelle, 37000, Tours
Institut Paoli-Calmettes
FR10012: Hematologie 1, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Montpellier
FR10013: Hématologie clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Bordeaux
FR10017: Service d’Hématologie clinique et therapie cellulaire, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Et Universitaire De Limoges
FR10025: Hématologie Clinique et Thérapie cellulaire, 2 Avenue Martin Luther King, 87000, Limoges
University Hospitals Pitie Salpetriere Charles Foix
FR10010: Hématologie Clinique, 47 To 83 Boulevard De L Hopital, 75013, Paris
Klinikum rechts der Isar der TU Muenchen AöR
#DE10003: III. Medizinische Klinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Wuerzburg AöR
#DE10001: Med. Klinik & Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Alexandra Hospital
GR10002: Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Evaggelismos Hospital
GR10001: Hemat/Transfusion Med, Ipsiladou 45-47, 106 76, Athens
Theageneio Cancer Hospital
GR10003: Hemat/Transfusion Med, Simeonidi Alex 2, 546 39, Thessaloniki
University Of Patras
GR10004: Dept of Internal Medicine/ Hematology Division, University Campus, 265 04, Patra
Careggi University Hospital
IT10004: Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Ospedale Policlinico San Martino
IT10011: Ematologia e Terapia Cellulari, Largo Rosanna Benzi 10, 16132, Genoa
Casa Sollievo Della Sofferenza
IT10005: Ematologia, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
IT10006: Ematologia Clinica, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Ospedale Niguarda Ca Granda
IT10031: Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliera S Maria Di Terni
IT10012: SC Oncoematologia, Viale Tristano Di Joannuccio 1, 05100, Terni
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
IT10001: Hematology, Strada Provinciale 142 Km 3,95, 10060, Candiolo
European Hematology Association
IT10020: Depoartmnt of Translation and Precision Medicine, Via Benevento 6, 00161, Rome
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
IT10003: SC Ematologia U, Corso Bramante 88, 10126, Turin
IRCCS Centro Di Riferimento Oncologico Della Basilicata
IT10029: Ematologia, Via Padre Pio 1, 85028, Rionero In Vulture
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
IT10025: Hematology Department Onco-Hematological DH and Bone Marrow Transplantation Center, Via Venezia 16, 15121, Alexandria
Universita' Degli Studi Di Perugia
IT10002: Hemat/Transfusion Med, Strada Di Sant Andrea Delle Fratte, 06132, Perugia
Azienda Ospedaliera Santa Croce E Carle
IT10028: Ematologia, Via Michele Coppino 26, 12100, Cuneo
Azienda Ospedaliero-Universitaria Maggiore Della Carita
IT10009: SCDU Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara
University Hospital Consorziale Policlinico
IT10024: Internal Medicine at Department of Biomedical Sciences and Human Oncology, Piazzale Giulio Cesare 11, 70124, Bari
University Hospital Consorziale Policlinico
IT10018: Ematologia, Piazzale Giulio Cesare 11, 70124, Bari
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
IT10021: U.O. Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
IT10017: Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Central Hospital Of Bolzano
IT10027: Ematologia, Via Lorenz Boehler 5, 39100, Bolzano
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
IT10008: " Ematologia", Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
IT10015: Oncoematology, Via Antonio Cardarelli 9, 80131, Naples
Azienda Ospedaliero Universitaria Delle Marche
IT10014: Ematologia, Via Conca 71, 60126, Ancona
Fondazione IRCCS Policlinico San Matteo
IT10007: Ematologia, Dip Oncoematologic, Viale Camillo Golgi 19, 27100, Pavia
Universita' Campus Bio-medico Di Roma
IT10030: Ematologia, Medicina Trasfusio, Via Alvaro Del Portillo 200, 00128, Rome
Amphia Hospital
NL10011: Int.Geneeskunde - Oncologie, Molengracht 21, 4818 CK, Breda
Albert Schweitzer Ziekenhuis
NL10003: Internal medicine, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
St. Elisabeth Hospital Tilburg
NL10001: Internal medicine, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Universitair Medisch Centrum Utrecht
NL10004: Van Creveldkliniek, Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Amsterdam UMC
NL10010: Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
NL10006: Hematology,Transfusion Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Haga Hospital
NL10009: Hematology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Universitair Medisch Centrum Groningen
NL10007: Hematology, Hanzeplein 1, 9713 GZ, Groningen
Leids Universitair Medisch Centrum (LUMC)
NL10008: Internal Medicine, Albinusdreef 2, 2333 ZA, Leiden
Uniwersyteckie Centrum Kliniczne
PL10004:Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
PL10003:Oddział Hematologii Ogólnej, Ul. Pabianicka 62, 93-513, Lodz
Institut Catala D'oncologia
ES10013: Hematología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Y Politecnico La Fe
ES10016: Hematología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Marques De Valdecilla
ES10022: Hematología, Avenida Valdecilla Sn, 39008, Santander
Hospital Clinic De Barcelona
ES10012: Hematología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Navarra
ES10018: Hematología, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario 12 De Octubre
ES10014: Hematología y Hemoterápia, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
ES10008: Hematología, Carretera Canyet S/n, 08916, Badalona
Hospital Universitari Vall D Hebron
ES10005: Hematología y Transfusión, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Clinical Hospital Virgen De La Arrixaca
ES10017: Hematología/Transfusión Med, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario De Salamanca
ES10007: Hematología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Clinico Universitario Lozano Blesa
ES10009: Hematología, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Central De Asturias
ES10020: Hematología, Avenida De Roma S/n, 33011, Oviedo
Clinica Universidad De Navarra
ES10024: Hematología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Ramon Y Cajal
ES10001: Hematología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario De Cabuenes
ES10019: Hematología, Calle Prados 395, Cabuenes, Gijon
Hospital General Universitario Morales Meseguer
ES10003: Hematología, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital General Universitario Gregorio Maranon
ES10004: Hematologia, Calle Del Doctor Esquerdo 46, 28007, Madrid
Clinica Universidad De Navarra
ES10011: Hematología, Avenue Pio XII 36, 31008, Pamplona
Institut Catala D'oncologia
ES10006: Hematología y Hemoterapia, Avinguda De Franca S/n, 17007, Girona
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 |
|---|---|---|---|---|---|
| Belgium | 2019-01-30 | 2019-03-19 | 2019-10-03 | ||
| Czechia | 2019-05-30 | 2019-06-03 | 2019-09-16 | ||
| Denmark | 2019-03-07 | 2019-03-22 | 2019-10-14 | ||
| France | 2019-04-03 | 2019-04-08 | 2019-10-22 | ||
| Germany | 2019-09-09 | 2019-10-14 | 2019-10-31 | ||
| Greece | 2018-12-24 | 2019-01-03 | 2019-10-14 | ||
| Italy | 2019-03-07 | 2019-03-08 | 2019-10-17 | ||
| Netherlands | 2019-02-05 | 2019-02-06 | 2019-10-17 | ||
| Norway | 2019-05-29 | 2019-08-08 | 2019-10-09 | ||
| Poland | 2019-04-24 | 2019-05-29 | 2019-10-01 | ||
| Spain | 2019-03-07 | 2019-03-18 | 2019-10-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 115 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506125-10-00 English Public | 7.0 |
| Protocol (for publication) | D1_Protocol 2023-506125-10-00 Greek Public | 7.0 |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L BEL Dutch EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L BEL French EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L CZE Czech EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L DEU German EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L DNK Danish EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L English EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L ESP Spanish EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L FRA French EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L GRC Greek EMN17-54767414MMY3014 Publi | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L ITA Italian EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L NLD Dutch EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L NOR Norwegian EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder EQ-5D-5L POL Polish EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 Czech EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 Danish EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 Dutch EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 English EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 French EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 German EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 Greek EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 Italian EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 Norwegian EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 Polish EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-C30 Spanish EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 Czech EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 Danish EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 Dutch EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 English EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 French EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 German EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 Greek EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 Italian EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 Norwegian EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 Polish EMN17-54767414MMY3014 Public | NA |
| Protocol (for publication) | D4_Patient Facing Documents TransPlaceholder QLQ-MY20 Spanish EMN17-54767414MMY3014 Public | NA |
| Recruitment arrangements (for publication) | K1_ ESP Recruitment arrangements_EMN17-54767414MMY3014 Public | NA |
| Recruitment arrangements (for publication) | K1_ NOR Recruitment arrangements_EMN17-54767414MMY3014 Public | NA |
| Recruitment arrangements (for publication) | K1_BEL_Recruitment Procedure_EMN17-54767414MMY3014 | NA |
| Recruitment arrangements (for publication) | K1_CZE Recruitment and ICF Procedure_EMN17-54767414MMY3014 | NA |
| Recruitment arrangements (for publication) | K1_DEU_Recruitment arrangements EMN17-54767414MMY3014 Public | NA |
| Recruitment arrangements (for publication) | K1_DNK Participant Letters Danish EMN17-54767414MMY3014 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_DNK Recruitment Arrangement English EMN17-54767414MMY3014 | NA |
| Recruitment arrangements (for publication) | K1_FRA Recruitment arrangements_EMN17-54767414MMY3014 | NA |
| Recruitment arrangements (for publication) | K1_GRC_Recruitment Procedure Description_ English_ EMN17-54767414MMY3014 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ITA_ICF Recruitment Procedure EMN17-54767414MMY3014 | NA |
| Recruitment arrangements (for publication) | K1_NLD ICF Recrutiemnt Procedure EMN17-54767414MMY3014 | NA |
| Recruitment arrangements (for publication) | K1_POL_Recruitment arrangements_EMN17-54767414MMY3014 | NA |
| Subject information and informed consent form (for publication) | L1_ NOR Country ICF Addendum Patient Letter_ Norwegian _ EMN17-54767414MMY3014 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ NOR Country ICF Main Adult_ Norwegian _EMN17-54767414MMY3014 Public | 10.1 |
| Subject information and informed consent form (for publication) | L1_ POL Country ICF Pregnant Medical Release Form_ Polish_EMN17-54767414MMY3014 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Adult Dutch EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Adult English EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Adult French EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Other Pregnant Partner Adult Dutch EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Other Pregnant Partner Adult English EMN17-54767414MMY3014 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Other Pregnant Partner Adult French EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BEL ICF Patient Letter Dutch EMN17-54767414MMY3014 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BEL ICF Patient Letter English EMN17-54767414MMY3014 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BEL ICF Patient Letter French EMN17-54767414MMY3014 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Country Pregnant partner Czech EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult already enroled Czech EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Other Patient letter Czech EMN17-54767414MMY3014 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Privacy Czech EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Research already enrolled Czech EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main_German_EMN17-54767414MMY3014 Public | 11.2 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Pregnant Partner_German_EMN17-54767414MMY3014 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_DEU Participant Letters_German_EMN17-54767414MMY3014 | 1.0 |
| Subject information and informed consent form (for publication) | L1_DNK Country ICF - Research Future Danish EMN17-54767414MMY3014 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DNK Country ICF Main Adult Danish EMN17-54767414MMY3014 Public | 11.1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Addendum_Spanish_ EMN17-54767414MMY3014 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Adult_Spanish_EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Other Adult_Spanish_ EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main Adult French EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Other Adult Pregnant Partner French EMN17-54767414MMY3014 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_FRA ICF Patient Letter French EMN17-54767414MMY3014 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Main Adult_English_EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Main Adult_Greek_EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Other Pregnant Partner_English_EMN17-54767414MMY3014 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Other Pregnant Partner_Greek_EMN17-54767414MMY3014 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Procedure_English_EMN17-54767414MMY3014 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_GRC Participant Letters_English_EMN17-54767414MMY3014 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_GRC Participant Letters_Greek_EMN17-54767414MMY3014 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF - Pregnant Form Adult Arabic PP ICF Arabic EMN17-54767414MMY3014 Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF - Pregnant Form Adult PP ICF Arabic EMN17-54767414MMY3014 Public | 4.2 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Data Protection English EMN17-54767414MMY3014 Public | 1.5 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Data Protection Italian EMN17-54767414MMY3014 Public | 2.3 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Future Research Italian EMN17-54767414MMY3014 Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Adult Italian EMN17-54767414MMY3014 Public | 11.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main English EMN17-54767414MMY3014 Public | 9.4 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Optional Future Research Italian EMN17-54767414MMY3014 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Patient letter Italian EMN17-54767414MMY3014 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Pregnant Partner Italian EMN17-54767414MMY3014 Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Addendum Dutch EMN17-54767414MMY3014 Public | 12.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Adult Dutch EMN17-54767414MMY3014_Public | 11.1 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Other Pregnant Partner Dutch EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Other Unborn baby Dutch EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Main Adult Appendix A_Norwegian_ EMN17-54767414MMY3014 Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Other Adult Pregnancy Norwegian EMN17-54767414MMY3014 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Research Future Norwegian EMN17-54767414MMY3014 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Adult Polish EMN17-54767414MMY3014 Public | 11.0 |
| Subject information and informed consent form (for publication) | L2_ITA Subject Materials Other English EMN17-54767414MMY3014 Public | 12.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BEL Dutch 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BEL French 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BEL German 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis CZE Czech 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis English 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ESP Spanish 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis FRA French 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis GRC Greek 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ITA Italian 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NLD Dutch 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NOR Norwegian 2023-506125-10-00 Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis POL Polish 2023-506125-10-00 Public | 7.0 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-19 | Denmark | Acceptable 2024-02-29
|
2024-02-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-30 | Denmark | Acceptable 2024-07-01
|
2024-07-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-16 | Acceptable 2024-07-01
|
2024-08-16 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-26 | Acceptable 2024-07-01
|
2024-08-26 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-30 | Acceptable | 2024-09-24 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-30 | Acceptable | 2024-10-07 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-30 | Acceptable | 2024-11-13 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-02 | 2024-12-09 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-05 | Acceptable | 2025-01-21 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-03-20 | Denmark | Acceptable 2025-06-06
|
2025-06-06 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-07 | Denmark | Acceptable 2025-08-01
|
2025-08-01 |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-12-11 | Denmark | Acceptable 2026-03-13
|
2026-03-13 |