A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
118actual
Sites
23
Countries
Australia, Brazil, China +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
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-04-05 | actual | When the study began enrolling |
| Primary completion | 2025-12-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-05-12 | estimated | The whole study's end, after follow-up |
| First posted | 2023-01-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsed/Refractory Multiple Myeloma
Interventions
- Drug: Isatuximab
- Drug: Carfilzomib — also filed as Kyprolis
- Drug: Dexamethasone
- Drug: Dexamethasone IV
- Drug: Montelukast
- Drug: Acetaminophen
- Drug: Diphenhydramine
- Drug: Methylprednisolone
Primary outcomes
what the primary-completion date above is the date OFOverall response rate (ORR) - Cohorts 1 to 3
measured 6 months after the Last Participant In (LPI) i.e., approximately 16 months
Maximum observed concentration (Cmax) over Cycle 1- Cohorts 4 to 5
measured Cycle 1 (28 days)
Cumulative area under the curve over the first 4 weeks (AUC4weeks) of isatuximab treatment- Cohorts 4 to 5
measured Cycle 1 (28 days)
Publications
- PMID 41455697 — 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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