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NCT03319667: Phase 3 - Isatuximab, Bortezomib, Lenalidomide and Dexamethasone NDMM (IMROZ)

Updated: Sep 25, 2022

IMROZ Study

NCT03319667

IMROZ study sanofi

Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant (IMROZ)



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), time to best response (TTBR), PFS on next line of therapy (PFS2), overall survival (OS), overall response rate (ORR) 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)


Sponsor

Sanofi


Multiple locations

International Study

 

ClinicalTrials.gov Identifier: NCT03319667

Official Title: 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

First Posted : October 24, 2017

Click here for details on ClinicalTrials.gov

 

Isatuximab

Lenaliodomide (R)

Bortezomib (V)

Dexamethasone (d)

 

Drug: Isatuximab SAR650984

Drug: Bortezomib

Drug: Lenalidomide

Drug: Dexamethasone

Drug: Acetaminophen (paracetamol) or equivalent

Drug: Ranitidine or equivalent

Drug: Diphenhydramine or equivalent

 

Locations

United States, Florida

United States, Missouri

United States, Tennessee

United States, Texas

Mexico

Australia, New South Wales

Australia, Queensland

Australia, Victoria

Australia, Western Australia

New Zealand

Belgium

China

Czechia

Denmark

France

Germany

Greece

Italy

Lithuania

Poland

Spain

Sweden

Portugal

Turkey

Asia

Japan

Russian Federation

Taiwan

 

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