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
← catalyst calendarNCT03319667 · readout in 229 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
475actual
Sites
104
Countries
Australia, Belgium, China +18
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 | 2017-12-07 | actual | When the study began enrolling |
| Primary completion | 2027-04-05 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2017-10-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-04 | 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: Bortezomib — also filed as Velcade®
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcome
what the primary-completion date above is the date OFProgression free survival (PFS)
measured Up to approximately 100 months after the First Participant In (FPI)
Publications
- PMID 41758929 — linked by the registry
- PMID 40109195 — linked by the registry
- PMID 38832972 — linked by the registry
- PMID 38573925 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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