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    Summary
    EudraCT Number:2014-002273-11
    Sponsor's Protocol Code Number:54767414MMY3008
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-002273-11
    A.3Full title of the trial
    A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy
    Studio di fase 3 per il confronto tra daratumumab, lenalidomide e desametasone (DRd) rispetto a lenalidomide e desametasone (Rd) in soggetti affetti da mieloma multiplo non precedentemente trattato non idonei alla terapia ad alta dose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants with Previously Untreated Multiple Myeloma
    Studio per il confronto Daratumumab, Leanlidomide e Desametasone con Lenalidomide e Desametasone in soggetti affetti da mieloma multiplo non precedentemente trattato
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number54767414MMY3008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number031715242166
    B.5.5Fax number031715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DARZALEX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab
    D.3.2Product code [HuMax-CD38]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414 (Daratumumab)
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale umano
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple myeloma
    Mieloma multiplo
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma
    Mieloma multiplo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
    L’obiettivo primario è confrontare l’efficacia di daratumumab se combinato con lenalidomide e desametasone (DRd) con quella di lenalidomide e desametasone (Rd) in termini di sopravvivenza libera da progressione (progression-free survival, PFS) in soggetti con mieloma multiplo (tumore delle cellule del plasma sanguigno) di nuova diagnosi che non sono candidati alla chemioterapia ad alta dose (trattamento della malattia, di solito tumore, mediante agenti chimici) e al trapianto autologo di cellule staminali.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate clinical outcomes including:
    - Time to disease progression (TTP)
    - Stringent CR (sCR) rate
    - CR rate
    - PFS2 (defined as time from randomization to progression on the next line of therapy or death, whichever comes first)
    - Time to next treatment
    - Overall response rate (CR + partial response [PR] rate)
    - Proportion of subjects who achieve very good partial response (VGPR) or better
    - Duration of response
    - Overall survival
    Gli obiettivi secondari sono:
    • Valutare gli esiti clinici, inclusi:
    - tempo alla progressione di malattia (time to progression, TTP);
    - tasso di risposta completa stringente (stringent complete response, sCR);
    - tasso di risposta completa (complete response, CR);
    - PFS2 (definita come tempo dalla randomizzazione alla progressione sulla linea terapeutica successiva o al decesso, a seconda di quale dei due si verifichi prima);
    - tempo al trattamento successivo;
    - tasso di risposta complessiva (CR + tasso di risposta parziale [partial response, PR]);
    - percentuale di soggetti che raggiungono una risposta parziale molto buona (very good partial response, VGPR) o meglio;
    - durata della risposta;
    - sopravvivenza globale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must have documented multiple myeloma satisfying the CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma and measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma
    (serum monoclonal paraprotein [Mprotein] level >=1.0 gram/deciliter [g/dL] or urine Mprotein level >=200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum Mprotein level >=0.5 g/dL or urine Mprotein level >=200 mg/24 hrs); or (c) light chain multiple myeloma without measurable disease in serum or urine (serum immunoglobulin free light chain >=10 mg/dL and
    abnormal serum immunoglobulin kappa lambda free light chain ratio)
    -Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
    -Participants who are newly diagnosed and not considered for highdose chemotherapy due to: being age >=65 years; or participants less than
    (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on
    tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization
    -Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 4 months after the last dose of daratumumab
    -Man, who is sexually active with a woman of childbearing potential potential must agree to use a latex or synthetic condom, even if he had a
    successful vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree
    to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab
    - Il partecipante deve essere affetto da mieloma multiplo che soddisfi il CRAB (aumento del calcio, insufficienza renale, anemia e anomalie dello scheletro, cellule plasmatiche monoclonali nel midollo spinale maggiore o uguale (>=) a 10% o presenza di una provata biopsia plasmacitoma e malattia misurabile definita come qualcuno dei seguenti: (a) immunoglobulina (Ig) G mieloma (livello del siero della paraproteina monoclonale [M-proteina] >=1.0 grammo/decilitro [g/dl] o livello di urina Mproteina >=200 milligrami [mg]/24 ore [h]; o (b) mieloma multiplo IgA, IgM, IgD, o IgE (livello serico M-proteina >=0.5 g/dl o livello di urina Mproteina >=200 mg/24 h); o (c) mieloma multiplo a catena leggera senza malattia misurabile nel siero o nelle urine (catena libera leggera del siero immunoglobulina >=10 mg/dl e velocità anormale della catena leggera libera del siero immunoglobulina kappa lambda free)
    - Il partecipante deve avere un punteggio dello stato di validità ECOG pari a 0, 1, o 2
    - I partecipanti con nuova diagnosi e considerati non candidati alla chemioterapia ad alta dose dovuto a: età >=65 anni; o participanti con età (<) 65 anni con presenza di condizioni importanti di comorbidità che potrebbero avere un impatto negativo sulla tollerabilità di alte dosi di chemioterapia con trapianto autologo di cellule staminali. E’ richiesta la revisione ed approvazione del promotore dei partecipanti al di sotto di 65 anni di età prima della randomizzazione.
    - le donne potenzialmente fertili devono impegnarsi ad astenersi in modo continuativo da rapporti sessuali o usare contemporaneamente 2 metodi affidabili di controllo delle nascite ritenuti appropriati dallo sperimentatore. La contraccezione deve iniziare 4 settimane prima del dosaggio e deve continuare per 4 mesi dopo l’ultima dose del daratumumab.
    - il soggetto maschile che è sessualmente attivo con una donna potenzialmente fertile deve acconsentire ad usare un profilattico di lattice o sintetico, anche se ha subito con successo un intervento di vasectomia, deve acconsentire ad usare un metodo di contraccezione ritenuto appropriato dallo sperimentatore e deve anche accettare di non donare lo sperma durante lo studio e per 4 settimane dopo l’ultima dose di lenalidomide e 4 mesi dopo l’ultima dose di daratumumab.
    E.4Principal exclusion criteria
    - Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum Mprotein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the Mprotein), or smoldering multiple myeloma
    (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
    - Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
    - Participant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the
    Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)
    - Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment
    -Participant has had radiation therapy within 14 days of randomization
    -Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] <50% of predicted normal), persistent asthma, or a history of
    asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed)
    -Participants with known or suspected COPD or asthma must have a FEV1 test during Screening
    -Participant is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have active hepatitis B or hepatitis C
    - Il partecipante ha una diagnosi di amiloidosi primaria, gammopatia monoclonale di rilevanza non definita (presenza di M-proteina serica <3 g/dl; assenza di lesioni ossee litiche, anemia, ipercalcemia, e insufficienza renale correlata alla M-proteina), o mieloma multiplo quiescente (mieloma multiplo asintomatico con assenza di danni agli organi o tessuti correlati – danno d’organo periferico)
    - il partecipante ha avuto una diagnosi di malattia di Waldenström, o altre condizioni nelle quali l’M proteina IgM è presente in assenza di infiltrazione cellulare plasma clonale con lesioni ossee litiche
    - il partecipante ha una storia di tumore maligno (diverso dal mieloma multiplo) nei 5 anni precedenti la data di randomizzazione (eccetto carcinoma a cellula squamosa e basale della pelle e carcinoma in situ della cervice, o tumore che secondo lo sperimentatore, e in parallelo all’opinione del medical monitor del promotore, si ritiene curato con rischio minimo di ricorrenza entro 5 anni)
    - il partecipante ha ricevuto o sta ricevendo una terapia sistemica o SCT per il mieloma multiplo, ad eccezione dell’uso in emergenza di un breve ciclo di cura (equivalente di desametasone 40 mg/giorno per un massimo di 4 giorni) di corticosteroidi prima del trattamento
    - il partecipante è stato sottoposto a radioterapia entro 14 giorni dalla randomizzazione
    - il partecipante è affetto da malattia cronica polmonare ostruttiva (COPD) (definita come volume di espirazione forzata in 1 secondo (FEV1) <50% rispetto al valore normale aspettato), asma persistente, o storia di asma negli ultimi 2 anni (l’asma intermittente controllata o l’asma lieve persitente controllata è permessa). I partecipanti con COPD nota o sospetta devono effettuare un test di FEV1 durante lo screening
    - il partecipante è sieropositivo al virus dell’immunodeficienza (HIV) o è affetto da epatite B o epatite C.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free Survival (PFS)
    Sopravvivenza libera da progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline for the duration of disease follow-up, with an expected average of 40 months
    Dal basale per la durata del follow-up della malattia, con una media attesa di 40 mesi
    E.5.2Secondary end point(s)
    1-Time to Disease Progression (TTP)
    2-Percentage of Participants With Stringent Complete Response (sCR)
    3-Percentage of Participants With Complete response (CR)
    4-Progression-Free Survival on Next Line of Therapy (PFS2)
    5-Percentage of Participants With Negative Minimal Residual Disease (MRD)
    6-Time To Next Treatment.
    7-Percentage of Participants With Overall Response (OR)
    8-Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
    9-Duration of Response (DR)
    10-Overall Survival (OS)Time
    11-European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
    12-Euro Quality of Life (EQ-5D-5L) Health State Profile Utility Score
    1- Tempo alla progressione di malattia (TTP)
    2- Tasso di partecipanti con risposta complete stringente (sCR)
    3- Tasso di partecipanti con risposta completa (CR) 4- Sopravvivenza libera da progressione per la terapia di seconda linea (PFS2)
    5- Tasso negativo MMR di partecipanti
    6- Tempo al successivo trattamento
    7- Tasso di risposta complessiva (overall response rate, ORR)
    8- Percentuale di soggetti che raggiunge una VGPR o più
    9- Durata della risposta (DR)
    10- Sopravvivenza globale (overall survival, OS)
    11- Punteggio del questionario sulla qualità della vita dell’Organizzazione Europea per la Ricerca e il Trattamento dei Tumori (EORTC QLQ-C30)
    12- Punteggio di utilità sullo stato di salute Qualità della Vita Europea (EQ-5D-5L).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2,3,4,6,7, 8 and 9 - From baseline for the duration of disease followup, with an expected average of 40 months
    5- From baseline up to 18 months after confirmed CR, with an expected average of 24 months
    10- Baseline up to 5 years after last participant is randomized
    11 and 12- From baseline up to 16 weeks after disease progression, with an expected average of 44 months
    1, 2, 3, 4, 6, 7, 8 e 9 – dal basale per la durata del follow-up della malattia, con una media attesa di 40 mesi
    5- dal basale fino a 18 mesi dal CR confermato, con una media attesa di 24 mesi
    10- dal basale fino a 5 anni dopo l’ultimo paziente arruolato
    11 e 12 – dal basale fino a 16 settimane dopo la progressione della malattia, con una media attesa di 44 mesi.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    daratumumab con o senza lenalidomide/desametasone
    daratumumab plus or minus lenalidomide/dexamethasone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Israel
    New Zealand
    United States
    Austria
    Denmark
    France
    Germany
    Ireland
    Italy
    Netherlands
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    the following is included in the protocol: The end of the study occurs after 330 subjects have died, or for a maximum of 5 years after the last subject is randomized, whichever occurs first.
    la seguente definizione è contenuta nel protocollo: lo studio terminerà dopo che 330 soggetti saranno deceduti, o per un massimo di 5 anni dopo che l'ultimo soggetto sarà stato randomizzato, quale dei due eventi avvenga prima.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 693
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    The Informed Consent dated and signed by the patient or a suitable representative from the legal poi
    Il Consenso Informato datato e firmato dal paziente o da un rappresentante adeguato dal punto di vis
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 213
    F.4.2.2In the whole clinical trial 730
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    See the protocol, The sponsor will ensure that ubjects benefiting from treatment with daratumumab will be able to continue treatment after the end of the study.
    Si veda il protocollo, il promotore si assicurerà che i soggetti che beneficino del trattamento con daratumumab possano continuare ad assumere il trattamento dopo la fine dello studio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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