CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 475 enrolled
Drug / intervention
Isatuximab SAR650984 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03319667
NCT03319667Phase 3Active
CompareCT.gov

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

Sanofi·interventional·Posted Oct 24, 2017·Updated May 4, 2026

In Brief

A Phase 3 clinical trial evaluating Isatuximab SAR650984, Bortezomib, and 2 other interventions for Plasma Cell Myeloma. Active but no longer recruiting, targeting 475 participants across 104 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasma Cell Myeloma
CountriesAustralia, Belgium, China, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Lithuania, Mexico, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3Active
2018201920202021202220232024202520262027
First PostedOct 24, 2017
Enrollment StartDec 7, 2017
Primary CompletionApr 5, 2027
Study CompletionJun 30, 2027
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 8.7 years agoPrimary completion in 9 months

Interventions

Isatuximab SAR650984drug

Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)

Bortezomibdrug

Pharmaceutical form: Lyophilized powder for injection Route of administration: Subcutaneous

Lenalidomidedrug

Pharmaceutical form: Capsules Route of administration: Oral

Dexamethasonedrug

Pharmaceutical form: Tablets, ampoules or vials for injection Route of administration: Oral/Intravenous