Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2026-02-13 @ 11:47 AM
Study NCT ID:
NCT04045795
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2019-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
Status:
COMPLETED
Status Verified Date:
2025-09
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:
None
Brief Summary:
Primary Objectives:
* To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
* To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device
* To evaluate the pharmacokinetics (PK) of SC and IV isatuximab
Secondary Objectives:
* To estimate absolute bioavailability of SC and IV isatuximab
* To measure receptor occupancy (RO) after isatuximab SC versus IV administration
* To assess efficacy of isatuximab after SC and IV administration
* To assess patient expectations prior to and patient experience and satisfaction after SC administration
* To evaluate potential immunogenicity of SC or IV isatuximab
* To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
* To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device
* To evaluate the pharmacokinetics (PK) of SC and IV isatuximab
Secondary Objectives:
* To estimate absolute bioavailability of SC and IV isatuximab
* To measure receptor occupancy (RO) after isatuximab SC versus IV administration
* To assess efficacy of isatuximab after SC and IV administration
* To assess patient expectations prior to and patient experience and satisfaction after SC administration
* To evaluate potential immunogenicity of SC or IV isatuximab
Detailed Description:
Total study duration is variable depending on treatment and follow-up periods, including 21 days of screening, and treatment period until disease progression, unacceptable adverse reaction or other reason for discontinuation. End of treatment will be 30 days after last administration of investigational medicinal product, or before further anti-myeloma therapy, whichever comes first; approximately 14 months after first study treatment administration.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: