SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
531actual
Sites
146
Countries
Argentina, Australia, Brazil +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 | 2022-06-23 | actual | When the study began enrolling |
| Primary completion | 2024-11-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-23 | estimated | The whole study's end, after follow-up |
| First posted | 2022-06-06 | actual | When this record first appeared on the registry |
| Results posted | 2025-11-14 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-11-14 | 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 Recurrent
Interventions
- Drug: Isatuximab IV — also filed as SAR650984, SARCLISA®
- Drug: Isatuximab SC — also filed as SAR650984
- Drug: Dexamethasone
- Drug: Pomalidomide — also filed as Pomalyst or equivalent
- Drug: Dexamethasone
- Drug: Montelukast
- Drug: Paracetamol / Acetaminophen
- Drug: Diphenhydramine
- Drug: Methylprednisolone
Primary outcomes
what the primary-completion date above is the date OFOverall Response Rate (ORR)
measured From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State
measured Pre-dose at Cycle 6 Day 1
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-07-10 · 9.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-10-24 · 903 KB · SAP_001.pdf
Publications
- PMID 40459178 — 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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