Last updated on April 2019

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


Brief description of study

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)

Detailed Study Description

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.

Clinical Study Identifier: NCT03319667

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Recruitment Status: Open


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