Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT05405166
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2022-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Sponsor:
Sanofi
Organization:
Study Overview
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)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRAKLIA
Brief Summary:
This is a 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 have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms:
Arm SC: Isatuximab SC + Pd
Arm IV: Isatuximab IV + Pd
Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Arm SC: Isatuximab SC + Pd
Arm IV: Isatuximab IV + Pd
Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Detailed Description:
Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: