A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
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Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
32actual
Sites
16
Countries
Australia, Belgium, Czechia +4
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
Why the sponsor stopped it
Early discontinuation based on sponsor decision not driven by any safety concerns; phase 2 was not initiated.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-05-15 | actual | When the study began enrolling |
| Primary completion | 2025-05-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-26 | actual | The whole study's end, after follow-up |
| First posted | 2023-05-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Relapsed/Refractory Multiple Myeloma
- Amyloid Light-chain Amyloidosis
Intervention
- Drug: SAR445514
Primary outcomes
what the primary-completion date above is the date OFDose escalation (part 1a - RRMM) Presence of dose limiting toxicities (DLT)
measured Cycle 1 - 4 weeks per cycle
Dose escalation (part 1a - RRMM) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
measured From Baseline to end of follow-up (approx. 15 months)
Dose optimization (part 2 - RRMM) Overall response rate (ORR)
measured Cycles 1 to 4 - 4 weeks per cycle
Dose escalation (part 1b - RRLCA) Presence of dose limiting toxicities (DLT) at cycle 1
measured Cycle 1 - 4 weeks per cycle
Dose escalation (part 1b - RRLCA) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
measured From baseline to end of follow-up (approx. 15 months)
Dose expansion (part 3 - RRMM) Overall response rate (ORR)
measured Cycles 1 to 4 - 4 weeks per cycle
Dose expansion (part 3-RRLCA) Hematological response (HR)
measured Cycles 1 to 4 - 4 weeks per cycle
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