Etude : IMROZ / EFC12522



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : IMROZ

Nom : EFC12522

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 16/09/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide (Revlimid®) and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Study arms:
- Experimental: Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
1. Induction treatment with 4x6-week cycles with intravenous (IV) isatuximab + subcutaneous (SC) bortezomib + oral lenalidomide + IV or oral dexamethasone
2. Continuous treatment with 4-week cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone

Interventions:
Drug: Isatuximab SAR650984, Route of administration: Intravenous (IV)
Drug: Bortezomib, Route of administration: Intravenous/Subcutaneous
Drug: Lenalidomide, Route of administration: Oral
Drug: Dexamethasone, Route of administration: Oral/Intravenous
Drug: Acetaminophen (paracetamol) or equivalent, Route of administration: Oral
Drug: Ranitidine or equivalent, Route of administration: Intravenous
Drug: Diphenhydramine or equivalent, Route of administration: Intravenous

- Active Comparator: Bortezomib/Lenalidomide/Dexamethasone = VRd arm
1. Induction treatment with 4x6-week cycles with SC bortezomib + oral lenalidomide + IV or oral dexamethasone
2. Continuous treatment with 4-week cycles with oral lenalidomide + IV or oral dexamethasone

Interventions:
Drug: Bortezomib, Route of administration: Intravenous/Subcutaneous
Drug: Lenalidomide, Route of administration: Oral
Drug: Dexamethasone, Route of administration: Oral/Intravenous

- Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Interventions:
Drug: Isatuximab SAR650984, Route of administration: Intravenous (IV)
Drug: Lenalidomide, Route of administration: Oral
Drug: Dexamethasone, Route of administration: Oral/Intravenous
Drug: Acetaminophen (paracetamol) or equivalent, Route of administration: Oral
Drug: Ranitidine or equivalent, Route of administration: Intravenous
Drug: Diphenhydramine or equivalent, Route of administration: Intravenous

The duration of the study for each patient will include a screening period of up to 4 weeks, an induction period of 24 weeks (4 cycles with a duration of 42 ± 4 days), a continuous treatment period and a crossover period (when applicable). The cycle duration is 28 ± 4 days during the continuous treatment and crossover periods

Primary Objective:
To demonstrate the benefit of isatuximab (I) in combination with bortezomib (V), lenalidomide (R) and dexamethasone (d) in the prolongation of progression free survival (PFS) as compared with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.

Secondary Objectives:
- To evaluate in both randomized arms: very good partial response (VGPR) or better rate as defined by the International Myeloma Working Group (IMWG) criteria, minimal residual disease (MRD) negativity rate in patients with complete response (CR) or VGPR, CR rate per IMWG criteria, time to progression (TTP) and overall by MRD status, PFS in MRD negative patients, duration of response (DOR) and overall by MRD status, time to first response (TT1R), PFS on next line of therapy (PFS2), overall survival (OS), overall response rate (ORR) (including crossover arm) per IMWG criteria (including crossover arm), safety (including crossover arm), and to assess disease-specific and generic health-related quality of life (HRQL)
- To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (excluding crossover arm)
- To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (including crossover arm)

Phase : III

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Multiple myeloma (IMWG criteria).
- Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or patients < 65 years with comorbidities impacting possibility of transplant.
- Evidence of measurable disease.
- Written informed consent.

Critères de non-inclusion : - Age < 18 years.
- Prior treatment for multiple myeloma.
- Any other prior or ongoing disease/health conditions incompatible with the study objectives.
- Organ function values not met.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ( PS) > 2.
- Hypersensitivity to the study medications.
- Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
- Male participants who disagree to follow the study contraceptive counseling.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03319667
Promoteur :
Sanofi
Type de sponsor : Industriel
54 rue La Boétie
75008 PARIS 08

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Thierry FACON

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Ouverture de l'essai : CLOS

MAJ : 16/09/2019