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
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
To evaluate potential immunogenicity of SC or IV isatuximab
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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