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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: Active Phase 3 study of Plasma Cell Myeloma, sponsored by Sanofi.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 475 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
What the registry record for NCT03319667 still lists
NCT03319667 is an interventional study that assigns participants to a tested intervention. The registered 475 participants enrollment target is mid-sized for trials with a published cap, above the 193-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (146% higher).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Plasma Cell Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03319667's enrollment target sits among peer trials
475 5th of 32 higher than 28 of 32 other Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Plasma Cell Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial
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