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

Plasma Cell Myeloma Clinical Trial

Official title: A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Status Active, not recruiting

Clinical Trial Summary

Primary Objective:

-To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.

Secondary Objectives:

• To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms:

• Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria.

• Minimal residual disease (MRD) negativity rate in patients with CR.

• Very good partial response or better rate, as defined by the IMWG criteria.

• Overall survival (OS).

• To evaluate the overall response rate (ORR) as per IMWG criteria.

• To evaluate the time to progression (TTP) overall and by MRD status.

• To evaluate PFS by MRD status.

• To evaluate the duration of response (DOR) overall and by MRD status.

• To evaluate time to first response (TT1R).

• To evaluate time to best response (TTBR).

• To evaluate progression-free survival on next line of therapy (PFS2).

• To evaluate the sustained MRD negativity >12 months rate.

• To evaluate safety.

• To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only).

• To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms).

• To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

Clinical Trial 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 ± 3 days), a continuous treatment period and a crossover period (when applicable). The cycle duration is 28 ± 3 days during the continuous treatment and crossover periods. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

• NCT number: NCT03319667
• Study type: Interventional
• Source: Sanofi
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 7, 2017
• Completion date: June 30, 2027