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

Condition(s) studied

Investigational drug(s) / intervention(s)

Isatuximab SAR650984: Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)

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

Lenalidomide: Pharmaceutical form: Capsules Route of administration: Oral

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

Study 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.

Eligibility

Primary outcome measure(s)

• Progression free survival (PFS) — Up to approximately 100 months after the First Participant In (FPI)
  Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) as determined by the independent review committee (IRC) or the date of death from any cause, whichever occurs first.

Trial sites (104)

+ 64 more sites — see the full list on the official registry below.

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