Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
← catalyst calendarNCT04270409 · readout in 1,517 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
337actual
Sites
105
Countries
Australia, Brazil, Canada +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-06-16 | actual | When the study began enrolling |
| Primary completion | 2030-10-14 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-10-21 | estimated | The whole study's end, after follow-up |
| First posted | 2020-02-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Plasma Cell Myeloma
Interventions
- Drug: Isatuximab SAR650984 — also filed as Sarclisa
- Drug: Lenalidomide
- Drug: Dexamethasone
- Drug: Montelukast or equivalent
- Drug: Acetaminophen
- Drug: Diphenhydramine or equivalent
- Drug: Methylprednisolone or equivalent
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with Treatment-emergent adverse events (AEs) and serious adverse events- Safety Run-in Part
measured Up to approximately 63 months
Plasma concentration of isatuximab during the treatment period - Safety Run-in Part
measured After first infusion from Cycle 1 Day 1 to Day 28 in safety run-in part
Receptor density/receptor occupancy Safety Run-in Part
measured Baseline to Cycle 2 Day 1 (each cycle is 28 days)
Progression-free survival (PFS) Randomized Phase 3 Part
measured Up to approximately 114 months
Permalink · SNY's whole pipeline · Catalyst calendar · Every registered study · What changed