Clinical Trials Detalhe
A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
General Information
Gender
ALL
Age
from 18 Years to 80 Years
Phase
PHASE3
Study Type
INTERVENTIONAL
Location
Investigational Site Number : 6200002 (Braga, Portugal)
Investigational Site Number : 6200006 (Coimbra, Portugal)
Investigational Site Number : 6200001 (Lisbon, Portugal)
Investigational Site Number : 6200005 (Porto, Portugal)
Investigational Site Number : 6200003 (Porto, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT03319667Summary
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 participants 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 participants 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 participants 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.
Conditions
Plasma Cell Myeloma
Eligibility
Inclusion Criteria: Inclusion criteria : * Multiple myeloma (IMWG criteria). * Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or participants \< 65 years with comorbidities impacting possibility of transplant. * Evidence of measurable disease. * Written informed consent. Exclusion criteria: * 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.