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SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Study acronym: IRAKLIA
StatusActive, Not Recruiting
PhasePhase 3
SponsorSanofi
Started2022-06-23
View on ClinicalTrials.gov ↗
This will be randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who will receive at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants were randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants are allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Amendment history 2 changes detected by DataLookout

2026-09-03
minor
Trial sites reduced: 146 → 128 locations
2026-09-03
minor
Completion pushed: 2027-03-23 → 2027-10-22
Trial Details
NCT Number NCT05405166
Lead Sponsor Sanofi
Conditions Plasma Cell Myeloma Recurrent
Enrollment 531 participants
Start Date 2022-06-23
Primary Completion 2024-11-06 (estimated)
Study Completion 2027-10-22 (estimated)
Updated on ClinicalTrials.gov 2026-09-02