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NCT03319667 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Plasma Cell Myeloma, sponsored by Sanofi.

Active
Registry status
Phase 3
Development phase
475
Enrollment target
20
Study locations

NCT03319667 is a Phase 3 study of Plasma Cell Myeloma that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 475 participants, above the 193-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (146% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT03319667, a Phase 3 study of Plasma Cell Myeloma, is active but no longer recruiting, sponsored by Sanofi.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
475 participants
Enrollment target
20
Study locations

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

Plasma Cell Myeloma

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

713 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, categorized as Phase 3. The registered enrollment target is 475 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 193-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (146% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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.

NCT03319667 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, New South Wales, Florida.

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.

What interventions are being tested in trial NCT03319667?

The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG), Isatuximab SAR650984 (DRUG).

Who is sponsoring clinical trial NCT03319667?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.