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ACTIVE NOT RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Bortezomib
  • DRUG Isatuximab SAR650984

Study Locations (20)

Other

  • Investigational Site Number : 0560001 — Liège
  • Investigational Site Number : 1560002 — Beijing
  • Investigational Site Number : 1560003 — Beijing
  • Investigational Site Number : 1560008 — Changchun
  • Investigational Site Number : 1560007 — Fuzhou
  • Investigational Site Number : 1560009 — Guangzhou
  • Investigational Site Number : 1560006 — Guangzhou

New South Wales

  • Investigational Site Number : 0360003 — Liverpool
  • Investigational Site Number : 0360001 — Waratah
  • Investigational Site Number : 0360002 — Wollongong

Florida

  • Investigational Site Number: 8400006 — Fort Myers
  • Investigational Site Number: 8400004 — St. Petersburg

Victoria

  • Investigational Site Number : 0360005 — Clayton
  • Investigational Site Number : 0360004 — Heidelberg West

Western Australia

  • Investigational Site Number : 0360006 — Nedlands
  • Investigational Site Number : 0360008 — West Perth

Missouri

  • Investigational Site Number: 8400007 — Kansas City

Tennessee

  • Investigational Site Number: 8400005 — Nashville

Texas

  • Investigational Site Number: 8400001 — Houston

Trial Details

FieldValue
Enrollment Target 475 participants
Start Date 2017-12-07
Est. Completion 2027-06-30
Phase Phase 3

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03319667

The ClinicalTrials.gov registry entry for NCT03319667 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 475 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Plasma Cell Myeloma appearing as the primary indexed condition, and to 4 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03319667 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, New South Wales, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03319667 about?

NCT03319667 is a clinical study titled "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". 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...

What is the current status of trial NCT03319667?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2017-12-07. Estimated completion is 2027-06-30.

What conditions does trial NCT03319667 study?

This clinical trial studies the following conditions: Plasma Cell Myeloma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03319667?

The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG), Isatuximab SAR650984 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03319667?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03319667 being conducted?

This trial has 20 study locations across Florida, Missouri, Tennessee, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial