Clinical Trials Register

Summary
EudraCT Number:	2017-001940-37
Sponsor's Protocol Code Number:	EFC15246
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:	2021-06-15
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-001940-37

A.3

Full title of the trial

Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis¿) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines

Studio randomizzato, in aperto, multicentrico per valutare il beneficio clinico di isatuximab in combinazione con carfilzomib (Kyprolis¿) e desametasone rispetto a carfilzomib e desametasone in pazienti affetti da mieloma multiplo recidivante e/o refrattario che abbiano ricevuto da 1 a 3 precedenti linee di trattamento

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Multinational Clinical Study Comparing Isatuximab,Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

Studio clinico internazionale per confrontare Isatuximab, Carfilzomib e Desametasone verso Carfilzomib e Desametasone in pazienti con mieloma multiplo recidivante e/o refrattario

A.3.2

Name or abbreviated title of the trial where available

IKEMA

A.4.1

Sponsor's protocol code number

EFC15246

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1195-5957

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	SANOFI -AVENTIS RECHERCHE ET DEVELOPPEMENT
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SANOFI S.p.A.
B.5.2	Functional name of contact point	CONTACT POINT
B.5.3	Address:
B.5.3.1	Street Address	VIALE BODIO, 37/B
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20158
B.5.3.4	Country	Italy
B.5.4	Telephone number	800226343
B.5.5	Fax number	0239394168
B.5.6	E-mail	informazioni.medicoscientifiche@sanofi.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1268
D.3 Description of the IMP
D.3.1	Product name	ISATUXIMAB
D.3.2	Product code	SAR650984
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Isatuximab
D.3.9.2	Current sponsor code	SAR650984
D.3.9.4	EV Substance Code	SUB119676
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	KYPROLIS
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN EUROPE B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	carfilzomib
D.3.2	Product code	na
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Carfilzomib
D.3.9.1	CAS number	868540-17-4
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB32911
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Desametasone 3.3 mg/ml soluzione per iniezione
D.2.1.1.2	Name of the Marketing Authorisation holder	hameln pharmaceuticals ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	desametasone
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESAMETASONE
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB125563
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Dexamethasone 4 mg JENAPHARM
D.2.1.1.2	Name of the Marketing Authorisation holder	JENAPHARM
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	desametasone
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESAMETASONE
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB125563
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	DexaGalen® 8 mg / 2 mL soluzione per iniezione
D.2.1.1.2	Name of the Marketing Authorisation holder	GALENpharma GmbH - numero MA: 49345.01.00
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Desametasone
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESAMETASONE
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	DEXAMETHASONE BASE
D.3.9.4	EV Substance Code	SUB125563
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Plasma cell myeloma

Mieloma plasmacellulare

E.1.1.1

Medical condition in easily understood language

Plasma cell myeloma

Mieloma plasmacellulare

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10035226
E.1.2	Term	Plasma cell myeloma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.

Dimostrare il beneficio clinico di isatuximab in combinazione con carfilzomib e
desametasone nel prolungamento della sopravvivenza libera da progressione
(PFS) rispetto a carfilzomib e
desametasone nei pazienti con mieloma multiplo (MM) recidivante e/o refrattario
che abbiano ricevuto da 1 a 3 precedenti linee di trattamento.

E.2.2

Secondary objectives of the trial

-To evaluate the ORR, rate of very good partial response(VGPR) or better and complete response (CR) rate in both arms using IMWG criteria.
-To evaluate rate of VGPR or better with minimal residual disease(MRD) negativity in both arms using IMWG criteria.
-To evaluate the Overall Survival (OS) in both arms
-To evaluate safety in both arms
-To evaluate duration of response(DOR) in both arms
-To evaluate the Time To Progression (TTP) in both arm
-Evaluate time from the date of randomization to the date of the second PD or death from any cause, whichever happen first (PFS2) in both arms
-Evaluate time to first response in both arms
-Evaluate time to best response in both arms
-To determine the Pharmacokinetic profile of isatux in combination with carfilzomib
-To evaluate the immunogenicity of isatux in isatux arm
-To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status in both arms

- Valutare
-tasso di risposta globale complessiva(ORR),di risposta parziale molto buona(VGPR)o migliore, di risposta completa(CR)in entrambi i brac(criteriIMWG)
-Tasso VGPR o migliore con negativit¿ alla malattia minima residua(MRD)in entrambi i brac(IMWG)
-OS in entrambi i brac
- sicurezza entrambi i brac
- Valutare DORin entrambi i brac
- Valutare TTPin entrambi i brac
- Valutare tempo dalla data di randomiz alla data di seconda PD o decesso per qualsiasi motivo, qualunque avvenga per primo (sopravvivenza libera da seconda progressione - PFS2) in entrambi i bracci.
- Valutare tempo alla prima risposta in entrambi i brac
-Valutare tempo alla miglior risposta in entrambi i brac
- Determina profilo PK di isatux e carfilzomib quando usati in combinaz
- Valutare immunogenicit di isatux nel braccio isatux
- Valutare HR QoL generica e specifica della malattia,sintomi relativi alla malattia e al tratt, vantaggio dello stato di salute e stato di salute in entrambi i brac

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patients with multiple myeloma previously treated with prior 1 to 3 lines and with measurable serum M-protein (= 0.5 g/dL) and/or urine M-protein (= 200 mg/24 hours).

- Pazienti con mieloma multiplo precedentemente trattati con 1 - 3 precedenti linee di trattamento e con proteina M sierica misurabile (=0,5 g/dl) e/o Proteina M nelle urine (=200 mg/24 ore)

E.4

Principal exclusion criteria

-Patients previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.
-Patients with serum free light chain (FLC) measurable disease only.
-Patients less than 18 years old, patients with Eastern Cooperative Oncology Group performance status more than 2.
-Patients with inadequate biological tests.
-Patients with myocardial infarction, sever/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.
-Patients with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
-Patients with known acquired immunodeficiency syndrome related illness (AIDS) or human immunodificiency virus (HIV) or requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
-Women of childbearing potential or male patient with women of childbearing potential who do not agree to use highly effective method of birth control.

- Pazienti precedentemente trattati con Carfilzomib, che non hanno mai ottenuto neanche una risposta minima durante le precedenti terapie e/o l'ultima precedente terapia completata negli ultimi 14 giorni
- Paziente con malattia misurabile solo mediante catene leggere libere sieriche
- Pazienti <18 anni, pazienti con Eastern Cooperative Oncology Group Performance status >2
- Pazienti con test biologici inadeguati
- Pazienti con infarto del miocardio, angina pectioris grave/instabile, bypass coronarico/periferico, insufficienza cardiaca congestizia di classe III/IV in base al New York Heart Association, aritmie di grado = 3, ictus o attacco ischemico transitorio negli ultimi 6 mesi, e/o frazione di eiezione ventricolare sinistra <40%
- Pazienti con precedente tumore maligno a meno che non siano liberi da malattia da più di 5 anni o si sia trattato di neoplasia in situ trattata con terapia curativa
- Pazienti con note malattie associate alla sindrome da immunodeficienza acquisita(AIDS) o virus da immunodeficienza umana (HIV) o che necessitino di trattamento antiretrovirale o presenza di
infezione da epatite A, B o C attiva.
- Donne potenzialmente fertili o pazienti di sesso maschile con partner potenzialmente fertili che non sono disposti ad utilizzare un metodo
contraccettivo altamente efficace

E.5 End points

E.5.1

Primary end point(s)

Progression Free Survival (PFS): The length of time between treatment
allocation and a patient lives with the disease but it does not get worse.

Sopravvivenza libera da progressione (PFS): intervallo di tempo tra l’allocazione del trattamento e la data di progressione di malattia.

E.5.1.1

Timepoint(s) of evaluation of this end point

up to approximately 36 months

Fino ad approssimativamente 36 mesi

E.5.2

Secondary end point(s)

1) Overall Response Rate (ORR): The proportion of patients that have a
response to their disease: stringent complete response (sCR), complete
response (CR), very good partial response (VGPR) or partial response
(PR)
2) Rate of VGPR or better: The proportion of patients with sCR, CR and
VGPR
3) CR rate: The proportion of patients with sCR and CR
4) Rate of VGPR or better with MRD(Minimal Residual Disease) negativity: The
proportion of patients with VGPR, CR or sCR and for whom MRD assessed by
sequencing is negative.
5) Overall Survival (OS): The length of time from the treatment
allocation for a disease that patients are still alive
6) Time to Progression (TTP): How long the study treatment last before
disease progression occurs
7) Second Progression Free Survial (PFS2): The length of time between
treatment allocation and second progression disease
8) Duration of response (DOR): How long from the first response is
observed until disease progression
9) Number of patients with adverse events according to the National
Cancer Institute - Common Toxicity Criteria(NCI- CTC) version 4.03
grading scaling: To evaluate how many adverse events occur while
taking study treatment
10) Patient-reported outcome measured with Quality of Life
questionnaire : To evaluate change in daily activities from
screening
11) Pharmacokinetics of isatuximab: To evaluate the plasma concentration
12) Pharmacokinetics of carfilzomib: To evaluate the plasma
concentration of carfilzomib in 12 patients
13) Immunogenicity (ADA): To evaluate presence of anti-drug antibodies
against isatuximab

1) Tasso di risposta globale: percentuale di pazienti con risposta completa stringente (sCR), risposta completa (CR), risposta parziale molto buona (VGPR) o risposta parziale (PR)
2) Tasso di VGPR o risposta migliore: percentuale di pazienti con sCR, CR e VGPR.
3) Tasso di CR: percentuale di pazienti con sCR e CR.
4) Tasso di VGPR o migliore con negativit¿ di MRD (malattia minima residua): percentuale dipazienti con VGPR, CR or sCR e la cui MRD valutata mediante sequenziamento risulti negativa.
5) Sopravvivenza globale: intervallo di tempo dall¿allocazione del trattamento al decesso
6) Tempo della progressione (TTP): durata del trattamento prima della progressione di malattia
7) Sopravvivenza libera da seconda progressione (PFS2): intervallo di tempo tra l¿allocazione del trattamento e la seconda progressione di malattia.
8) Durata della risposta (DOR): tempo intercorso tra il momento della prima risposta e la progressione di malattia
9) Numero di pazienti con eventi avversi in base alla scala di valutazione Common Toxicity Criteria (NCI-CTC) del National Cancer Institute (V4.03): valutare quanti eventi avversi si verificano durante l¿assunzione del trattamento in studio
10) Outcome riportato dal paziente valutato tramite Questionario di qualit¿ della vita: valutare il cambiamento nelle attivit¿ quotidiane a partire dello screening.
11) Farmacocinetica di isatuximab: valutare la concentrazione plasmatica di isatuximab
12) Farmacocinetica di Carfilzomib: valutare la concentrazione plasmatica di carfilzomib in 12 pazienti
13) Immunogenicit¿ (ADA): valutare la presenza di anticorpi anti-farmaco ( isatuximab.)

E.5.2.1

Timepoint(s) of evaluation of this end point

1), 2), 3), 4), 6), 7), 8) up to approximately 36 months
5) up to approximately 72 months
9) Up to 30 days after last study treatment administration
10) Dallo Screening to 90 days after last study treatment administration
11) up to approximately10 months
12) up to 1 month
13) Up to 13 months

1), 2), 3), 4), 6), 7), 8) Fino ad approssimativamente 36 mesi
5) Fino ad approssimativamente 72 mesi
9) Fino a 30 giorni dopo l¿ultima somministrazione del trattamento
10) Screening fino a 90 giorni dopo l¿ultima somministrazione del trattamento
11) Fino ad approssimativamente 10 mesi
12) Fino a 1 mese
13) Fino a 13 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Brazil

Canada

Japan

Korea, Republic of

New Zealand

Russian Federation

Turkey

United States

France

Greece

Hungary

Italy

Spain

United Kingdom

Czechia

E.8.7

Trial 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

Approximately 3 years after analysis of primary endpoint

Approssimativamente 3 anni dopo l'analisi dell'endpoint primario

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

140

F.4.2.2

In the whole clinical trial

300

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)

None

Nessuno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-01-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-10-26

P. End of Trial
P.	End of Trial Status	Ongoing

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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