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Clinical trial · no report yet · Phase 3

IRAKLIA

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

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
YouTube29
X threads18
Podcasts12

The trial

ClinicalTrials.gov
Official title
A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Phase
Phase 3
Status
Active not recruiting
Conditions
Plasma Cell Myeloma Recurrent
Interventions
Isatuximab IV; Isatuximab SC; Dexamethasone; Pomalidomide; Dexamethasone; Montelukast; Paracetamol / Acetaminophen; Diphenhydramine; Methylprednisolone
Arms
  • Isatuximab Subcutaneous (SC) · Experimental
  • Isatuximab Intravenous (IV) · Active comparator
Enrollment
531
Primary outcomes
  • Overall Response Rate (ORR)
  • Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State
Sponsor
Sanofi
Start
Jun 23, 2022
Primary completion
Nov 6, 2024
Results posted
Yes
Registry record
NCT05405166 · updated Sep 2, 2026

Publications

linked from the registry
  • Ailawadhi S, Spicka I, Spencer A, Lu J, Oriol A, Ling S, Schjesvold F, Berkovits A, Hus M, Li C, Dimopoulos MA, Rajnics P, Besisik SK, Hungria V, Custidiano MDR, Parmar G, Leleu X, Li F, Cerchione C, Gomez C, Ishida T, Mateos MV, Buck TT, LeBlanc R, Minarik J, Goldschmidt H, Zhang R, Semiond D, Suzan F, Stefanova-Urena M, Koch V, Moreau P. Isatuximab Subcutaneous by On-Body Injector Versus Isatuximab Intravenous Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Phase III IRAKLIA Study. J Clin Oncol. 2025 Aug;43(22):2527-2537. doi: 10.1200/JCO-25-00744. Epub 2025 Jun 3. PubMed 40459178