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NCT04270409 · ClinicalTrials.gov registry record · Phase 3
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
A Phase 3 study of Plasma Cell Myeloma, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 337
- Enrollment target
- 20
- Study locations
NCT04270409: Active Phase 3 study of Plasma Cell Myeloma, sponsored by Sanofi.
NCT04270409 is a Phase 3 study of Plasma Cell Myeloma that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 337 participants, above the 198-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (70% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04270409, 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
- 337 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objectives: * Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) * Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in Part: * To assess overall response rate (ORR) * To assess duration of response (DOR) * To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) * To assess time to diagnostic (SLiM CRAB) progression or death * To assess time to first-line treatment for multiple myeloma (MM) * To assess the potential immunogenicity of isatuximab * Impact of abnormal chromosomal subtype on participant outcome Randomized Phase 3 Part: Key Secondary Objectives: To compare between the arms * MRD negativity * Sustained MRD negativity * Second progression-free survival (PFS2) * Overall survival Other Secondary Objectives: To evaluate in both arms * CR rate * ORR * DOR * Time to diagnostic (SLiM CRAB) progression * Time to biochemical progression * Time to first-line treatment for MM * Impact of abnormal chromosomal subtype on participant outcome * Safety and tolerability * Pharmacokinetics (PK) * Potential of isatuximab immunogenicity * Clinical outcome assessments (COAs)
Conditions Studied
Interventions
- DRUG Acetaminophen
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Isatuximab SAR650984
- DRUG Montelukast or equivalent
Study Locations (20)
New South Wales
- Investigational Site Number :0360008 - Liverpool
- Investigational Site Number :0360005 - Waratah
- Investigational Site Number :0360001 - Wollongong
Victoria
- Investigational Site Number :0360002 - Fitzroy
- Investigational Site Number :0360007 - Heidelberg West
- Investigational Site Number :0360004 - Richmond
Florida
- Cancer Specialist of North Florida Site Number : 8400011 - Jacksonville
- University of Miami Site Number : 8400012 - Miami
North Carolina
- Presbyterian Hospital Site Number : 8400015 - Charlotte
- Novant Health Forsyth Medical Center Site Number : 8401015 - Winston-Salem
California
- UCLA Site Number : 8400010 - Los Angeles
Colorado
- Colorado Blood Cancer Institute Site Number : 8400007 - Denver
Massachusetts
- Dana Farber Cancer Institute Site Number : 8400001 - Boston
Tennessee
- Tennessee Oncology Site Number : 8400006 - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 337 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2033-10-21 |
| Phase | Phase 3 |
What the registry record for NCT04270409 still lists
NCT04270409 is an interventional study that assigns participants to a tested intervention. The registered 337 participants enrollment target is mid-sized for trials with a published cap, above the 198-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (70% higher).
The record links to 1 condition, with Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Acetaminophen is the first listed.
NCT04270409 names 20 study sites across 14 states, led by New South Wales, Victoria, Florida.
Frequently Asked Questions
What is clinical trial NCT04270409 about?
NCT04270409 is a clinical study titled "Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma". Primary Objectives: * Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) * Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with...
What is the current status of trial NCT04270409?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 337 participants. The study started on 2020-06-16. Estimated completion is 2033-10-21.
What conditions does trial NCT04270409 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma.
What interventions are being tested in trial NCT04270409?
The interventions under investigation include: Acetaminophen (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Isatuximab SAR650984 (DRUG), Montelukast or equivalent (DRUG).
Who is sponsoring clinical trial NCT04270409?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04270409 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Massachusetts, North Carolina. 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 NCT04270409's enrollment target sits among peer trials
337 8th of 32 higher than 25 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
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