A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
—
Status
Completed
Study type
Observational
Enrollment
583actual
Sites
129
Countries
Argentina, Austria, Belgium +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 | 2020-08-13 | actual | When the study began enrolling |
| Primary completion | 2026-02-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-23 | actual | The whole study's end, after follow-up |
| First posted | 2020-07-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-29 | 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: Pomalidomide — also filed as Pomalyst
- Drug: Dexamethasone
- Drug: Carfilzomib
Primary outcomes
what the primary-completion date above is the date OFOverall response rate (ORR)
measured 12 months
Progression free survival (PFS)
measured Up to 30 months
Progression free survival rate (PFSR)
measured up to 18 months
Duration of response (DoR)
measured Up to 30 months
Time to response (TTR)
measured Up to 30 months
Time to first subsequent anti-myeloma therapy
measured Up to 30 months
Rate of very good partial response or better
measured 12 months
Rate of complete response (CR) or better
measured 12 months
Number of Participants with Adverse events
measured Up to 1 month after the end of treatment
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30)
measured through end of treatment (up to approximately 2 years)
Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)
measured through end of treatment (up to approximately 2 years)
Permalink · SNY's whole pipeline · Catalyst calendar · Every registered study · What changed