EudraCT Number:2021-002639-48
Sponsor's Protocol Code Number:54767414AMY2009
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:2022-01-27
Trial results
A. Protocol Information
A.1Member State ConcernedItaly - Italian Medicines Agency
A.2EudraCT number2021-002639-48
A.3Full title of the trial
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis
Studio multicoorte di fase 2 sulle terapie a base di daratumumab in partecipanti con amiloidosi da amiloide a catena leggera (Amyloid Light, AL)
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis
Studio multicoorte di fase 2 sulle terapie a base di daratumumab in partecipanti con amiloidosi da amiloide a catena leggera (Amyloid Light, AL)
A.3.2Name or abbreviated title of the trial where available
A.4.1Sponsor's protocol code number54767414AMY2009
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.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 CM
B.5.4Telephone number+31715242166
B.5.5Fax number+31715242110
B.5.6E-mail[email protected]
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. of the Marketing Authorisation holderJanssen-Cilag International NV
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/3/18/2020
D.3 Description of the IMP
D.3.1Product nameDaratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
D.3.2Product code [JNJ-54767414]
D.3.4Pharmaceutical form Solution for injection/infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPSubcutaneous 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
D.3.9.3Other descriptive nameHuMax-CD38, 3003-005
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 number120
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. cell therapy medicinal product Information not present in EudraCT
D. therapy medical product Information not present in EudraCT
D. Engineered Product Information not present in EudraCT
D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D. 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. medicinal product typehuman monoclonal antibody
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
Amyloid Light Chain Amyloidosis
Amiloidosi da amiloide a catena leggera (Amyloid Light, AL)
E.1.1.1Medical condition in easily understood language
E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 23.0
E.1.2Level LLT
E.1.2Classification code 10083938
E.1.2Term Amyloid light-chain amyloidosis
E.1.2System Organ Class 100000004870
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
Cohort 1:
- to characterize cardiac safety of different D-VCd treatment regimens in
newly diagnosed systemic AL amyloidosis with cardiac involvement
- to identify potential mitigation strategies for cardiac toxicity
Cohort 2:
- to characterize the PK of SC daratumumab, among racial and ethnic
minorities with newly diagnosed systemic AL amyloidosis treated with DVCd
Coorte 1, caratterizzare la sicurezza cardiaca di diversi regimi di trattamento con daratumumab, ciclofosfamide, bortezomib, e desametasone (D-VCd) nell’amiloidosi AL sistemica di nuova diagnosi con coinvolgimento cardiaco e identificare potenziali strategie di mitigazione per indirizzare le strategie di mitigazione clinica insieme al confronto di diversi schemi di trattamento) per la tossicità cardiaca.
Coorte 2, caratterizzare la farmacocinetica di daratumumab somministrato per via sottocutanea (SC), in diverse minoranze razziali ed etniche, comprese quelle nere o afroamericane, con nuova diagnosi di amiloidosi AL trattata con daratumumab SC in combinazione con VCd.
E.2.2Secondary objectives of the trial
- to evaluate efficacy measures
- to assess the safety profile, including cardiac events
- to characterize the PK of SC daratumumab
- to assess the immunogenicity of SC daratumumab
- to monitor the clinical signs and symptoms of cardiac AL amyloidosis to
identify possible predictive factors for cardiac events
-valutazioni di efficacia
-valutazione il profilo di sicurezza, e event cardiaci
-valutazioni farmacocinetiche
-valutazioni di immunogeneticità
-Valutazione dei segni e sintomi cardiaci correlati all'amiloidosi AL per identificare potenziali indicatori di eventi cardiaci
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- =18 years of age.
- New diagnosis of systemic AL amyloidosis based on both: (a) tissue
deposition of amyloid in any organ other than bone marrow and (b) an
underlying clonal plasma cell disorder as demonstrated by any one of the
• Clonal plasma cells in the bone marrow
• Monoclonal gammopathy in the serum or urine
• Abnormal free light chain ratio
- Measurable disease at screening defined by difference between iFLC
and uninvolved FLC (dFLC) =40mg/L per central laboratory
- Cohort 1: Cardiac involvement (AL amyloidosis Mayo Cardiac Stage II
and Stage IIIa; see Appendix 6) with or without other organ(s) involved
- Cohort 2: One or more organs impacted by systemic AL amyloidosis
according to consensus guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status score
of 0, 1 or 2.
- Pre-treatment clinical laboratory values meeting the following criteria
during the Screening Phase:
• Hemoglobin =8.0 g/dL (=5 mmol/L); red blood cell transfusion
allowed until 7 days before randomization/enrollment
• Platelets =50×109/L; platelet transfusions are allowed until 7 days
before randomization/enrollment
• Absolute Neutrophil count =1.0×109/L
• Aspartate aminotransferase and alanine aminotransferase =2.5× ULN
• Total bilirubin =1.5 × ULN; except in participants with congenital
bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin =
2×ULN is required)
• Estimated glomerular filtration rate =20 mL/min/1.73 m2
- A female participant of childbearing potential must have a negative
serum or urine test at screening and within 72 hours of the first dose of
study treatment and must agree to further serum or urine pregnancy
tests during the study.
- A female participant must be either of the following:
a. Not of childbearing potential
b. Of childbearing potential and practicing true abstinence or have a sole
partner who is vasectomized or practicing at least 1 highly effective user
independent method of contraception
Contraception must begin 4 weeks prior to dosing and continue for 1
year after discontinuation of cyclophosphamide or 3 months after
discontinuation of daratumumab, whichever is longer.
- A male participant must wear a condom (with or without spermicidal
foam/gel/film/cream/suppository) when engaging in any activity that
allows for passage of ejaculate to another person during the study and
for 6 months after discontinuation of cyclophosphamide or 3 months
after discontinuation of daratumumab, whichever is longer. His female
partner, if of childbearing potential, must also be practicing a highly
effective method of contraception.
If the male participant is vasectomized, he still must wear a condom
(with or without spermicidal foam/gel/film/cream/suppository), but his
female partner is not required to use contraception.
- A female participant must agree not to donate eggs (ova, oocytes) or
freeze for future use, for the purposes of assisted reproduction during
the study and for a period of least 1 year after the last dose of
cyclophosphamide or 3 months after discontinuation of daratumumab,
whichever is longer.
- A male participant must agree not to donate sperm for the purpose of
reproduction during the study and for a minimum of 6 months after
receiving the last dose of cyclophosphamide or 3 months after
discontinuation of daratumumab, whichever is longer.
- Signed an informed consent form (ICF).
• Cohort 2 only: self-identified racial and ethnic minorities, including
Black or African American.
- =18 anni di età.
- Nuova diagnosi di amiloidosi sistemica AL basata su entrambi: (a) tessuto
deposizione di amiloide in qualsiasi organo diverso dal midollo osseo e b) un
alla base del disturbo delle plasmacellule clonali, come dimostrato da uno qualsiasi dei
• Plasmacellule clonali nel midollo osseo
• Gammopatia monoclonale nel siero o nelle urine
• Rapporto anomalo della catena leggera libera
- Malattia misurabile allo screening definita dalla differenza tra iFLC
e FLC non coinvolto (dFLC) =40 mg/ L per laboratorio centrale
- Valori di laboratorio clinico pre-trattamento che soddisfano i seguenti criteri
durante la Fase di Screening:
• Emoglobina =8,0 g/dL (=5 mmol/L); trasfusione di globuli rossi
consentito fino a 7 giorni prima della randomizzazione/iscrizione
• Piastrine =50×109/L; le trasfusioni piastriniche sono consentite fino a 7 giorni
prima della randomizzazione/iscrizione
• Conta assoluta dei neutrofili =1.0×109/L
• Aspartato aminotransferasi e alanina aminotransferasi =2,5× ULN
• Bilirubina totale =1,5 × ULN; tranne che nei partecipanti con congenita
bilirubinemia, come la sindrome di Gilbert (nel qual caso la bilirubina diretta =
2×ORAN è obbligatorio)
• Velocità di filtrazione glomerulare stimata =20 mL/min/1,73 m2
- Una partecipante di sesso femminile in età fertile deve avere un negativo
test del siero o delle urine allo screening ed entro 72 ore dalla prima dose di
studiare il trattamento e deve accettare un'ulteriore gravidanza sierica o urinaria
test durante lo studio.
- Una partecipante di sesso femminile deve essere una delle seguenti:
a. Non di potenziale fertile
b. Di potenziale fertile e praticare la vera astinenza o avere una sogliola
partner che è vasectomizzato o che pratica almeno 1 utente altamente efficace
metodo contraccettivo indipendente
La contraccezione deve iniziare 4 settimane prima della somministrazione e continuare per 1 anno dopo l'interruzione del ciclofosfamide o 3 mesi dopo
interruzione del trattamento con daratumumab, a seconda di quale sia il periodo più lungo.
- Un partecipante di sesso maschile deve accettare di non donare sperma allo scopo di
riproduzione durante lo studio e per un minimo di 6 mesi dopo
ricevere l'ultima dose di ciclofosfamide o 3 mesi dopo
interruzione del trattamento con daratumumab, a seconda di quale sia il periodo più lungo.
- Firmato un modulo di consenso informato (ICF).
• Solo coorte 2: minoranze razziali ed etniche auto-identificate, tra cui
Nero o afroamericano.
E.4Principal exclusion criteria
- Prior therapy for systemic AL amyloidosis or multiple myeloma
including medications that target CD38, with the exception of 160 mg
dexamethasone or equivalent corticosteroid maximum exposure prior to randomization/enrollment.
- Previous or current diagnosis of symptomatic multiple myeloma per
International Myeloma Working Group (IMWG) Criteria.
- Participant received any of the following therapies:
a. treatment with an investigational drug or used an invasive
investigational medical device within 14 days or at least 5 half-lives,
whichever is less.
b. vaccinated with an investigational vaccine (except for COVID-19, live
attenuated or replicating viral vector vaccines within 4 weeks prior to
- Stem cell transplantation – Planned stem cell transplant during the first
9 cycles of protocol therapy are excluded. Stem cell collection during the
first 9 cycles of protocol therapy is permitted.
- Grade 2 sensory or Grade 1 painful peripheral neuropathy.
- Evidence of significant cardiovascular conditions (as specified in
- History of malignancy (other than AL amyloidosis) within 3 years
before the date of randomization
- Contraindications or life-threatening allergies, hypersensitivity, or
intolerance to any study treatment or its excipients, including
bortezomib, boron, mannitol, or cyclophosphamide or any of its
- Known allergies, hypersensitivity, or intolerance to monoclonal
antibodies, hyaluronidase, human proteins, or their excipients, or known
sensitivity to mammalian-derived products
- Pregnant or breastfeeding or planning to become pregnant while
enrolled in this study or within 1 year after discontinuation of
cyclophosphamide or 100 days after the last dose of daratumumab,
whichever is longer
- Plans to father a child while enrolled in this study or within 100 days
after the last dose of study treatment
- Chronic obstructive pulmonary disease (COPD) with a Forced
Expiratory Volume in 1 second (FEV1) <50% of predicted normal
- Moderate or severe persistent asthma within the past 2 years, or
currently has uncontrolled asthma of any classification
- Participant is known to be positive for human immunodeficiency virus
(HIV), with 1 or more of the following:
• Not receiving highly active antiretroviral therapy (ART)
• Had a change in ART within 6 months of the start of screening
• Receiving ART that may interfere with study treatment (consult
Sponsor for review of medication prior to enrollment)
• CD4 count <350 at screening
• Acquired immunodeficiency syndrome (AIDS)-defining opportunistic
infection within 6 months of start of screening
• Not agreeing to start ART and be on ART >4 weeks plus having HIV
viral load <400 copies/mL at end of 4-week period (to ensure ART is
tolerated and HIV controlled)
- Seropositive for hepatitis B (defined by a positive test for hepatitis B
surface antigen [HbsAg]). (Conditions for resolved infection are
specified in protocol)
- 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).
- Any serious underlying medical or psychiatric condition or disease, that
is likely to interfere with study procedures or results, or that in the
opinion of the investigator would constitute a hazard for participating in
this study, such as:
• Evidence of serious active viral or bacterial infection, requiring
systemic antimicrobial therapy, or uncontrolled systemic fungal
(please refer to section 5.2 of the protocol for other exclusion criteria)
- Precedente terapia per amiloidosi sistemica AL o mieloma multiplo
compresi i farmaci che hanno come bersaglio CD38, ad eccezione di 160 mg
desametasone o corticosteroide equivalente esposizione massima prima di randomizzazione/iscrizione.
- Diagnosi precedente o attuale di mieloma multiplo sintomatico per
Criteri del gruppo di lavoro internazionale sul mieloma (IMWG).
- Il partecipante ha ricevuto una delle seguenti terapie:
a. trattamento con un farmaco sperimentale o usato un invasivo
dispositivo medico sperimentale entro 14 giorni o almeno 5 emivite,
a seconda di quale sia inferiore.
b. vaccinati con un vaccino sperimentale (ad eccezione del COVID-19, vivi
vaccini virali vettori attenuati o replicanti entro 4 settimane prima di
- Trapianto di cellule staminali – Trapianto di cellule staminali pianificato durante il primo
Sono esclusi 9 cicli di terapia protocollare. Raccolta di cellule staminali durante la
sono consentiti i primi 9 cicli di terapia protocollare.
- Neuropatia periferica sensoriale o dolorosa di grado 2 o di grado 1.
- Evidenza di condizioni cardiovascolari significative (come specificato in
- Storia di malignità (diversa dall'amiloidosi AL) entro 3 anni
prima della data di randomizzazione
- Controindicazioni o allergie potenzialmente letali, ipersensibilità, o
intolleranza a qualsiasi trattamento in studio o ai suoi eccipienti, tra cui
bortezomib, boro, mannitolo o ciclofosfamide o uno qualsiasi dei suoi
- Allergie note, ipersensibilità o intolleranza al monoclonale
anticorpi, ialuronidasi, proteine umane o loro eccipienti, o noti
sensibilità ai prodotti derivati dai mammiferi
- Gravidanza o allattamento o pianificazione di una gravidanza durante
arruolati in questo studio o entro 1 anno dall'interruzione del trattamento
ciclofosfamide o 100 giorni dopo l'ultima dose di daratumumab,
a seconda di quale sia più lungo.
- Prevede di generare un bambino mentre è iscritto a questo studio o entro 100 giorni
dopo l'ultima dose di trattamento in studio
- Broncopneumopatia cronica ostruttiva (BPCO) con una forzata
Volume espiratorio in 1 secondo (FEV1) <50% del normale previsto
- Asma persistente moderata o grave negli ultimi 2 anni, o
attualmente ha asma incontrollata di qualsiasi classificazione
- Il partecipante è noto per essere positivo al virus dell'immunodeficienza umana (HIV), con 1 o più dei seguenti elementi:
• Non ricevere una terapia antiretrovirale altamente attiva (ART)
• Ha avuto un cambiamento nella ART entro 6 mesi dall'inizio dello screening
• Ricevere ART che può interferire con il trattamento dello studio (consultare
Sponsor per la revisione dei farmaci prima dell'iscrizione)
• Conteggio CD4 <350 alla proiezione
• Sindrome da immunodeficienza acquisita (AIDS) che definisce opportunisticamente infezione entro 6 mesi dall'inizio dello screening
• Non accettare di iniziare ART ed essere su ART >4 settimane più avere l'HIV
carica virale <400 copie/ml alla fine del periodo di 4 settimane (per garantire che ART sia
tollerato e controllato dall'HIV)
- Sieropositivo per l'epatite B (definito da un test positivo per l'epatite B
antigene di superficie [HbsAg]). (Le condizioni per l'infezione risolta sono
specificato nel protocollo)
- Noto per essere sieropositivo per l'epatite C (tranne che nel contesto di un
risposta virologica sostenuta [SVR], definita come aviremia almeno 12
settimane dopo il completamento della terapia antivirale).
- Qualsiasi grave condizione o malattia medica o psichiatrica di base, che
è suscettibile di interferire con le procedure o i risultati dello studio, o che nel
l'opinione dello sperimentatore costituirebbe un pericolo per la partecipazione a
questo studio, come ad esempio:
• Evidenza di gravi infezioni virali o batteriche attive, che richiedono
terapia antimicrobica sistemica o fungina sistemica incontrollata
( per gli altri criteri di esclusione, fare riferimento alla sezione 5.2 del protocollo)
E.5 End points
E.5.1Primary end point(s)
Cohort 1:
- incidence and severity of cardiac events
Cohort 2:
- Il parametro PK primario è C (trough) alla fine di
dosaggio settimanale (Ciclo 3 Giorno 1 predose)]
Coorte 1:
- incidenza e gravità degli eventi cardiaci
Coorte 2:
- The primary PK parameter is C trough at the end of
weekly dosing (Cycle 3 Day 1 predose)
E.5.1.1Timepoint(s) of evaluation of this end point
-Cohort 1: approximately 12-months after 120 participants have been randomized.
-Cohort 2: cycle 3 day 1 predose
-Coorte 1: circa 12 mesi dopo che 120 partecipanti sono stati randomizzato.
-Coorte 2: ciclo 3 giorno 1 predose
E.5.2Secondary end point(s)
- Overall HemCR and HemCR rate at 6 months
- Rate of VGPR or better
- Time to HemCR (or VGPR or better)
- Duration of response (HemCR and VGPR or better)
- Organ response rate (OrRR) at 6 months and 12 months for kidney,
heart, liver
- Overall survival (OS)
- Time to next treatment (TNT)
- Incidence and severity of AEs
- Pharmacokinetic profile of daratumumab
- Immunogenicity of daratumumab and rHuPH20
- Clinical signs and symptoms of cardiac AL amyloidosis
-Tasso complessivo di HemCR e HemCR a 6 mesi
- Tasso di VGPR o superiore
- Tempo di HemCR (o VGPR o superiore)
- Durata della risposta (HemCR e VGPR o superiore)
- Tasso di risposta degli organi (OrRR) a 6 mesi e 12 mesi per i reni,
cuore, fegato
- Sopravvivenza globale (OS)
- Tempo al prossimo trattamento (TNT)
- Incidenza e gravità degli eventi avversi
- Profilo farmacocinetico di daratumumab
- Immunogenicità di daratumumab e rHuPH20
- Segni e sintomi clinici dell'amiloidosi cardiaca AL
E.5.2.1Timepoint(s) of evaluation of this end point
HemCR rate at 6 months
OrRR at 6 and 12 months
All other secondary end points during the conduct of the study.
HemCR rate at 6 months
OrRR at 6 and 12 months
All other secondary end points during the conduct of the study.
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 No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Yes
E.6.11Pharmacogenomic No
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. trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
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 Yes
E. trial design description
Coorte 2 non é randomizzato
Cohort 2 is not randomized
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other Yes
E. description
Cohort 1: different treatment schedule. VCd starting at cycle 1 day 1 or at cycle 4 day 1.
Cohort 1: different treatment schedule. VCd starting at cycle 1 day 1 or at cycle 4 day 1.
E.8.2.4Number of treatment arms in the trial3
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 concerned4
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA21
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
United Kingdom
United States
E.8.7Trial has a data monitoring committee No
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
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months10
E.8.9.1In the Member State concerned days14
E.8.9.2In all countries concerned by the trial years3
E.8.9.2In all countries concerned by the trial months10
E.8.9.2In all countries concerned by the trial days14
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: 80
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 70
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 No
F.4 Planned number of subjects to be included
F.4.1In the member state50
F.4.2 For a multinational trial
F.4.2.1In the EEA 78
F.4.2.2In the whole clinical trial 150
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)
Subjects will be instructed that study drug will not be available to them after they have completed/discontinued treatment and that they should return to their primary physician to determine standard of care (Prot Sect 6.7).Patients receiving daratumumab and who continue to benefit from the study treatment when study is over will have the option to continue on daratumumab treatment for a max of 2 year from the start of the study. Sponsor plans to provide study medication to these patients.
I soggetti saranno istruiti che il farmaco in studio non sarà disponibile per loro dopo aver completato / interrotto il trattamento e che dovrebbero tornare dal loro medico di base per determinare lo standard di cura I pazienti che ricevono daratumumab e che continuano a beneficiare del trattamento in studio al termine dello studio avranno la possibilità di continuare il trattamento con daratumumab per un massimo di 2 anni dall'inizio 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 Decision2022-04-26
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-02-08
P. End of Trial
P.End of Trial StatusOngoing