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

• Status: Active, not recruiting
• Trial end date: 2025-04-15
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Acetaminophen; BB 1101; Bortezomib; Dexamethasone; Dexamethasone acetate; Diphenhydramine; Lenalidomide; Promethazine; Ranitidine; Ranitidine bismuth citrate; Thalidomide

Criteria

Inclusion criteria :

• Multiple myeloma (IMWG criteria).

• Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or patients < 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.