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Brief Title: International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
Official Title: 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
Study ID: NCT05669989
Brief Summary: * This is a multi-center, open-label, Phase 2 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. * 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Washington University School of Medicine Site Number : 8400001, Saint Louis, Missouri, United States
Investigational Site Number : 0360001, St Leonards, New South Wales, Australia
Investigational Site Number : 0360003, Wollongong, New South Wales, Australia
Investigational Site Number : 0360004, Fitzroy, Victoria, Australia
Investigational Site Number : 0360002, Richmond, Victoria, Australia
Instituto COI de Educacao e Pesquisa Site Number : 0760001, Rio De Janeiro, , Brazil
Investigational Site Number : 1520001, Temuco, , Chile
Investigational Site Number : 1560001, Tianjin, , China
Investigational Site Number : 2030001, Praha 2, , Czechia
Investigational Site Number : 2460001, Helsinki, , Finland
Investigational Site Number : 2500002, Nantes, , France
Investigational Site Number : 3000001, Patra, , Greece
Investigational Site Number : 3800002, Torino, , Italy
Investigational Site Number : 3920001, Okayama-shi, Okayama, Japan
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 6430001, Moscow, , Russian Federation
Investigational Site Number : 7240004, Santander, Cantabria, Spain
Investigational Site Number : 7241001, Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240001, Pamplona, Navarra, Spain
Investigational Site Number : 7240003, Madrid, , Spain
Investigational Site Number : 7240002, Salamanca, , Spain
Investigational Site Number : 7520004, Luleå, , Sweden
Investigational Site Number : 1580001, Taichung, , Taiwan
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR