Clinical Trials Register

Summary
EudraCT Number:	2018-004330-15
Sponsor's Protocol Code Number:	D20180138
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-12-07
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

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2018-004330-15

A.3

Full title of the trial

A multi-center phase III randomized study comparing continuous versus fixed duration therapy with Daratumumab, Lenalidomide, and Dexamethasone for relapsed multiple myeloma

Étude de phase III randomisée, multicentrique, comparant l’administration continue ou pour une durée fixe de l’association daratumumab, lenalidomide et dexaméthasone dans le myélome multiple en rechute

A.3.1

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

A multi-center phase III randomized study comparing continuous versus fixed duration therapy with Daratumumab, Lenalidomide, and Dexamethasone for relapsed multiple myeloma

A.3.2

Name or abbreviated title of the trial where available

CONFIRM

A.4.1

Sponsor's protocol code number

D20180138

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	Assistance Publique - Hôpitaux de Paris (AP-HP)
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Inca
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	Assistance Publique - Hôpitaux de Paris (AP-HP)
B.5.2	Functional name of contact point	DRCI Hôpîtal Saint-Louis
B.5.3	Address:
B.5.3.1	Street Address	DRCI Hôpital St Louis, 1 av. Claude Vellefaux
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75010
B.5.3.4	Country	France
B.5.4	Telephone number	33144841780
B.5.5	Fax number	33144841701
B.5.6	E-mail	maud.jacubert@aphp.fr

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	Yes
D.2.1.1.1	Trade name	DARZALEX
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG
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	Yes
D.2.5.1	Orphan drug designation number	EU/1/16/1101
D.3 Description of the IMP
D.3.1	Product name	Daratumumab
D.3.4	Pharmaceutical form	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	DARATUMUMAB
D.3.9.1	CAS number	945721-28-8
D.3.9.4	EV Substance Code	SUB175772
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
D.3.11.13.1	Other medicinal product type	human monoclonal antibody
D.IMP: 2
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	Yes
D.2.1.1.1	Trade name	REVLIMID
D.2.1.1.2	Name of the Marketing Authorisation holder	CELGENE
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	Lenalidomide
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 25
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Dexamethasone
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.1	CAS number	50-02-2
D.3.9.4	EV Substance Code	SUB07017MIG
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

multiple myeloma

myelome multiple

E.1.1.1

Medical condition in easily understood language

myeloma

myelome

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10051381
E.1.2	Term	Myeloma recurrence
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The present randomized trial is primarily designed to show the non-inferiority in overall survival at 4 years of the Dara-Len-Dex combination for treatment of MM at first relapse administered for a fixed duration of 24 months (experimental arm) versus continuous administration (control arm) until disease progression

Cet essai randomisé est principalement conçu pour montrer la non-infériorité sur la survie globale à 4 ans de l'association Dara-Len-Dex pour le traitement du MM en première rechute, administrée pendant une durée fixe de 24 mois (bras expérimental) versus administration continue (bras témoin) jusqu'à progression de la maladie

E.2.2

Secondary objectives of the trial

Secondary objectives are:
• To compare:
- the response rate after salvage therapy and achievement of a minimal residual disease
- the overall response rate following salvage therapy
- progression-free survival (PFS)
- Serious adverse events
• To compare the impact of the treatment strategies on Quality of Life (QoL).
• To perform a cost-effectiveness analysis
• To perform a budget impact analysis

Objectifs secondaires :
• Comparer :
- le taux de réponse après le traitement de rattrapage et le taux d'obtention de maladie résiduelle minime négative (MRD)
- le taux de réponse global après traitement de rattrapage
- la survie sans progression (SSP)
- les événements indésirables graves
• Comparer l'impact des stratégies de traitement sur la Qualité de Vie (QdV).
• Effectuer une analyse coût-efficacité
• Effectuer une analyse d'impact budgétaire

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

To assess durability of MRD negativity

Evaluer la durabilité de la négativité de la MRD

E.3

Principal inclusion criteria

1/ Adult patients (≥ 18 years old)
2/ Documented MM in relapse according to standard criteria and requiring initiation of a first line salvage therapy.
3/ Subject must have received one prior line of therapy for MM.
4/ Subject must have achieved a response (PR or better) to the prior regimen.
5/ Subject must have an ECOG Performance Status score of 0, 1, or 2.
6/ For subjects experiencing serious toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.
7/ Signed informed consent
8/ Affiliation to a social security system or equivalent (recipient or assign)
9/ Effective method of contraception for the duration of treatment and 3 months after the last dose for women and men with a partner of childbearing age:
• Progestin-only pill associated with inhibition of ovulation
• Hormonal methods of contraception, including oral contraceptive pills containing a combination of estrogen + progesterone, vaginal ring, injectables, implants and intrauterine devices (IUDs)
• non-hormonal IUD
• Bilateral tubal occlusion
• Vasectomized partner with documented azoospermia 90 days after procedure and who received a medical assessment of surgical success
• Intrauterine hormone release system (IUS)
• Complete Abstinence: Complete abstinence is defined as the complete avoidance of heterosexual intercourse. Complete abstinence is an acceptable form of contraception for all study drugs and must be used throughout the duration of the study and for the duration of time as specified above. It is not necessary to use any other method of contraception when complete abstinence is elected. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.

1/ Patient adulte (≥ 18 ans)
2/ MM en rechute (documenté) selon des critères standards IMWG et nécessitant l'initiation d'une première thérapie de rattrapage.
3/ Le sujet doit avoir reçu une ligne de traitement antérieure pour MM.
4/ Le sujet doit avoir obtenu une réponse (PR ou mieux) à la ligne de traitement antérieure.
5/ Le sujet doit avoir un score d'état de performance ECOG de 0, 1 ou 2.
6/ Pour les sujets présentant des toxicités résultant d'un traitement antérieur (y compris la neuropathie périphérique), les toxicités doivent avoir été résolues ou stabilisées.
7/ Consentement éclairé signé
8/ Affiliation à un système de sécurité sociale ou équivalent (destinataire ou assignateur)
9/ Méthode de contraception efficace pendant toute la durée du traitement et 3 mois après la dernière prise pour les femmes et les hommes ayant une partenaire en âge de procréer :
• Pilule progestative associée à l’inhibition de l’ovulation
• Méthodes hormonales de contraception, y compris les pilules contraceptives orales contenant une combinaison d'œstrogène + progestérone, anneau vaginal, injectables, implants et Dispositifs intra-utérins (DIU)
• DIU non hormonal
• Occlusion tubaire bilatérale
• Homme vasectomisé avec une azoospermie documentée 90 jours après la procédure et qui a reçu une évaluation médicale du succès chirurgical
• Système de libération d'hormones intra-utérines (IUS)
• Abstinence complète : abstinence complète est définie comme l'évitement complet de rapports hétérosexuels, forme de contraception acceptable pour tous les médicaments d'étude et doit être utilisé pendant toute la durée de l'étude et pour la durée du temps spécifié ci-dessus. Il n'est pas nécessaire d'utiliser une autre méthode de contraception lorsque l'abstinence est complète. Des méthodes alternatives acceptables de contraception hautement efficaces doivent être discutées dans le cas où le sujet choisit de renoncer à l'abstinence complète

E.4

Principal exclusion criteria

1/ Evidence of refractoriness or intolerance to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). If previously treated with a lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) -containing regimen, the subject is excluded if he or she:
• Discontinued due to any severe adverse event related to prior lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) treatment, or
• If, at any time point, the subject was refractory to any dose of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Refractoriness to lenalidomide and/or daratumumab is defined either as:
o Subjects whose disease progressed within 60 days of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) administration; or
o Subjects whose disease is nonresponsive while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Nonresponsive disease is defined as either failure to achieve at least a minimal response or development of progressive disease while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody).
2/ Subject has received an allogenic stem cell transplant (regardless of timing).
3/ Subjects planning to undergo a stem cell transplant prior to progression of disease on this study, ie, these subjects should not be enrolled in order to reduce disease burden prior to transplant.
4/ Subject has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years).
5/ Subject has known MM meningeal involvement.
6/ Subject has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström’s macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
7/ Subject has any concurrent medical condition or disease (eg, active systemic infection) 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.
8/ Subject has known uncontrolled chronic obstructive pulmonary disease (COPD)
9/ Subject has clinically significant cardiac disease.
10/ Subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
11/ Creatinine clearance ≤30 mL/min (MDRD method) (lenalidomide dose adjustment will be considered for subjects with creatinine clearance 30-60 mL/min).
12/ Hypersensitivity to the active substance or to any of the excipients

1/ Patient réfractaire ou preuve d'intolérance au lénalidomide et/ou au daratumumab (ou autre anticorps monoclonal anti-CD38). S'il a déjà été traité avec une ligne de traitement contenant du lénalidomide ou du daratumumab (ou autre anticorps monoclonal anti-CD38), le sujet est exclu si :
• l’interruption du traitement est due à un événement indésirable grave lié au traitement antérieur par le lénalidomide et/ou le daratumumab (ou autre anticorps monoclonal anti-CD38), ou
• si, à tout moment, le sujet était réfractaire à toute dose de lénalidomide et/ou de daratumumab (ou autre anticorps monoclonal anti-CD38). Est considéré réfractaire au lénalidomide et/ou au daratumumab (ou autre anticorps monoclonal anti-CD38):
o sujets dont la maladie a progressé dans les 60 jours suivant l'administration de lénalidomide et/ou de daratumumab (ou autre anticorps monoclonal anti-CD38); ou
o sujets dont la maladie ne répond pas pendant le traitement par le lénalidomide et/ ou le daratumumab. Une maladie non réactive est définie comme l'incapacité à obtenir au moins une réponse minimale ou la progression de la maladie pendant le traitement par le lénalidomide et/ou le daratumumab (ou autre anticorps monoclonal anti-CD38).
2/ Sujet ayant reçu une allogreffe de cellules souches hématopoïétiques (indépendamment du moment).
3/ Sujets éligibles pour subir une greffe de cellules souches avant la progression de la maladie dans le cadre de cette étude, c'est-à-dire que ces sujets ne devraient pas être inscrits afin de réduire le fardeau de la maladie avant la transplantation.
4/ Sujet avec des antécédents de malignité (autres que MM) dans les 3 ans précédant la date de randomisation (sauf les carcinomes épidermoïdes et basocellulaires de la peau, les carcinomes in situ du col de l'utérus ou les tumeurs malignes qui, de l'avis de l'investigateur guéri avec un risque minimal de récidive dans les 3 ans).
5/ Sujet ayant eu une atteinte méningée MM.
6/ Sujet avec une leucémie plasmocytaire (> 2,0 × 109/L de plasmocytes circulants par différentiel standard) ou macroglobulinémie de Waldenström ou syndrome POEMS (polyneuropathie, organomégalie, endocrinopathie, protéines monoclonales, altérations cutanées) ou amyloïdose.
7/ Sujet souffrant d'un trouble médical ou d'une maladie concomitante (ex. infection systémique active) susceptible d'interférer avec les procédures ou les résultats de l'étude ou qui, de l'avis de l'investigateur, constituerait un danger pour la participation à cette étude.
8/ Sujet avec une maladie pulmonaire obstructive chronique (MPOC) non contrôlée
9/ Sujet a une maladie cardiaque cliniquement significative.
10/ Sujet avec statut séropositif pour le virus de l'immunodéficience humaine (VIH), l'hépatite B ou l'hépatite C connu.
11/ Clairance de la créatinine ≤ 30 mL/min (méthode MDRD) (ajustement de la dose de lénalidomide sera envisagé pour les sujets ayant une clairance de la créatinine comprise entre 30 et 60 mL/min).
12/ Hypersensibilité à la substance active ou à l’un des excipients

E.5 End points

E.5.1

Primary end point(s)

Overall survival (OS) at 4 years after randomization and initiation of salvage therapy

Survie globale à 4 ans après randomisation et initiation du traitement de rattrapage

E.5.1.1

Timepoint(s) of evaluation of this end point

4 years

4 ans

E.5.2

Secondary end point(s)

• Response rate according to the IMWG criteria (Durie BG, et al. Leukemia. 2006;20:1467–1473; Rajkumar SV, et al. Blood. 2011;4691-4695), during or after the study treatment at the time of data cutoff.
• Overall response rate, defined as the proportion of subjects who achieve CR or PR according to the IMWG criteria, following salvage therapy.
• PFS which is defined as the duration from the date of randomization to either progressive disease, according to the IMWG criteria or death, at 4 years after randomization.
• Incidence of adverse events within the 4 years after randomization.
• QoL will be evaluated after randomization every 12 weeks until disease progression and then at last follow-up based on the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and the EQ-5D 5L (EuroQol - five dimension - five levels).
• The Incremental cost-effectiveness ratios (ICERs) expressed in cost per quality adjusted life year (QALY) gained, in cost per Life Year Gained, and in cost per progression free year gained.
• The budget impact analysis based upon target and prevalent populations’ estimations.

• Taux de réponse selon les critères IMWG (Durie BG, et al. Leukemia. 2006;20:1467–1473; Rajkumar SV, et al. Blood. 2011;4691-4695), pendant ou après le traitement de l'étude au moment de l’analyse des données.
• Taux de réponse global, défini comme la proportion de sujets qui atteignent CR ou PR selon les critères IMWG, suite à une thérapie de rattrapage.
• PFS qui est définie comme la durée depuis la date de la randomisation jusqu’à progression de la maladie (selon les critères IMWG) ou décès, à 4 ans après la randomisation.
• Incidence des événements indésirables dans les 4 années suivant la randomisation.
• QdV sera évaluée après la randomisation toutes les 12 semaines jusqu'à la progression de la maladie, puis au dernier suivi sur la base du questionnaire EORTC QLQ-C30 (Questionnaire sur la qualité de vie du noyau de l'Organisation européenne pour la recherche et le traitement du cancer - Core 30) et du questionnaire EQ-5D 5L (EuroQol - cinq dimensions - cinq niveaux).
• Les rapports coûts-efficacité incrémentaux (ICERs) exprimés en coût par année de vie pondérée par la qualité (QALY) gagnée, en coût par année de vie gagnée, et en coût par année sans progression gagnée.
• Analyse d'impact budgétaire basée sur les estimations des populations cibles et la prévalence.

E.5.2.1

Timepoint(s) of evaluation of this end point

4 years

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

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

association Dara-Len-Dex pendant une durée fixe vs traitement jusqu'à progression de la maladie

fixed duration of Dara-Len-Dex combination vs treatment until disease progression

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LVLS

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

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:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

284

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

434

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

Aucun

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

2018-12-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-10

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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