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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

NCT03319667 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2026-05-04

No results posted yet for this 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.

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

Isatuximab SAR650984

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

DRUG

Bortezomib

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

DRUG

Lenalidomide

Pharmaceutical form: Capsules Route of administration: Oral

DRUG

Dexamethasone

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2027-04-05
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03319667 on ClinicalTrials.gov