Clinical Trial: NCT03319667
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
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Sanofi |
| Information Provided By: | Sanofi |
| Last Update Posted: | 2026-05-04 |
Study Overview
Brief 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 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.
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
Conditions
Plasma Cell Myeloma
Intervention / Treatment
- Drug: Isatuximab SAR650984
- Drug: Bortezomib
- Drug: Lenalidomide
- Drug: Dexamethasone
Other Study ID Numbers
- EFC12522
- U1111-1194-2121
- 2024-514417-34
- 2017-002238-21
- 2017
Start Date (Actual)
2017-12-07
Primary Completion Date (Estimated)
2027-04-05
Study Completion Date (Estimated)
2027-06-30
Enrollment (Actual)
475
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Sanofi |
| Information Provided By: | Sanofi |
| Last Update Posted: | 2026-05-04 |
Study Overview
Brief 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 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.
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
Conditions
Plasma Cell Myeloma
Intervention / Treatment
- Drug: Isatuximab SAR650984
- Drug: Bortezomib
- Drug: Lenalidomide
- Drug: Dexamethasone
Other Study ID Numbers
- EFC12522
- U1111-1194-2121
- 2024-514417-34
- 2017-002238-21
- 2017
Start Date (Actual)
2017-12-07
Primary Completion Date (Estimated)
2027-04-05
Study Completion Date (Estimated)
2027-06-30
Enrollment (Actual)
475
Study Type
Interventional
Phase
Phase 3