Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

NCT04270409 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 337 participants
Start Date 2020-06-16
Est. Completion 2033-10-21
Phase Phase 3

Sponsor

Sanofi

275 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04270409

The ClinicalTrials.gov registry entry for NCT04270409 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 337 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 5 interventions — of which Acetaminophen 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: NCT04270409 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New South Wales, Victoria, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04270409?

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 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.

Related

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