NCT05669989

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Detailed description

Participants can continue the treatment until disease progression, unacceptable adverse events, participant wish to discontinue study treatment, study treatment is commercially available and reimbursed in participant's country, or for any other reason, whichever comes first. The overall study duration will be of approximately 42 months.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab intravenous (IV)	Route of administration: IV infusion; Pharmaceutical form: Vial
DRUG	Cemiplimab (SAR439684)	Route of administration: IV infusion; Pharmaceutical form: Vial
DRUG	Dexamethasone	Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
DRUG	Lenalidomide	Route of administration: Oral; Pharmaceutical form: Capsules
DRUG	Pomalidomide	Route of administration: Oral; Pharmaceutical form: Hard capsules
DRUG	Isatuximab subcutaneous (SC)	Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
DRUG	Carfilzomib	Route of administration: IV infusion; Pharmaceutical form: Vial

Timeline

• Start date: 2023-04-05
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2023-01-03
• Last updated: 2025-01-23

Locations

37 sites across 17 countries: United States, Australia, Brazil, Chile, China, Czechia, Finland, France, Greece, Italy, Japan, New Zealand, Russia, South Korea, Spain, Sweden, Taiwan

Regulatory

• FDA-regulated drug study