Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2025-12-24 @ 1:47 PM
NCT ID:
NCT04045795
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
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:
NCT04045795
Study Brief:
Protocol Section:
NCT04045795