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NCT05669989 · ClinicalTrials.gov record · last posted 2026-07-31

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

StatusEnrolling by Invitation
PhasePhase 2
SponsorSanofi
Started2023-04-05
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from the ClinicalTrials.gov record
* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Protocol amendment history 3 changes detected by DataLookout

2026-08-01
notable
Trial status changed: Active, Not Recruiting → Enrolling by Invitation
2026-08-01
critical
Primary completion pushed: 2026-11-30 → 2028-11-30
2026-08-01
minor
Completion pushed: 2026-11-30 → 2028-11-30
Trial Details
NCT Number NCT05669989
Lead Sponsor Sanofi
Conditions Plasma Cell Myeloma
Enrollment 70 participants
Start Date 2023-04-05
Primary Completion 2028-11-30 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-31