- Active, not recruiting
NCT03319667: Phase 3 - Isatuximab, Bortezomib, Lenalidomide and Dexamethasone NDMM (IMROZ)
Updated: Sep 25, 2022
IMROZ Study
NCT03319667
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
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
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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