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

Source: https://onco.cc/trials/nct04270409/  
OnCo record `nct04270409` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Isatuximab, Lenalidomide and Dexamethasone in multiple myeloma, run by Sanofi, active and no longer recruiting.

## Summary

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma is a phase 3 interventional study registered as NCT04270409 by Sanofi, with 337 participants enrolled, started 2020-06-16 and due to reach its primary completion in 2030-10-14. Interventions recorded: Isatuximab SAR650984, Lenalidomide, Dexamethasone, Montelukast or equivalent, Acetaminophen and Diphenhydramine or equivalent.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04270409
- Phase: 3
- Setting: A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma
- Sponsor: Sanofi
- Enrolled: 337

## Sources

- ClinicalTrials.gov NCT04270409: https://clinicaltrials.gov/study/NCT04270409

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/)
- drugs: [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Isatuximab](https://onco.cc/drugs/isatuximab/), [Lenalidomide](https://onco.cc/drugs/lenalidomide/)
- companies: [Sanofi](https://onco.cc/companies/sanofi/)

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JSON: https://onco.cc/api/v1/entities/nct04270409.json