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Spots Global Cancer Trial Database for International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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