* 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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Route of administration: IV infusion; Pharmaceutical form: Vial
Route of administration: IV infusion; Pharmaceutical form: Vial
Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
Route of administration: Oral; Pharmaceutical form: Capsules
Route of administration: Oral; Pharmaceutical form: Hard capsules
Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
Route of administration: IV infusion; Pharmaceutical form: Vial
Washington University- Site Number : 8400001
St Louis, Missouri, United States
Investigational Site Number : 0360006
Blacktown, New South Wales, Australia
Investigational Site Number : 0360001
Saint Leonards, New South Wales, Australia
Investigational Site Number : 0360003
Wollongong, New South Wales, Australia
Investigational Site Number : 0360004
Melbourne, Victoria, Australia
Number of participants with treatment-emergent adverse events
Time frame: Baseline to 42 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number : 0360005
Melbourne, Victoria, Australia
Investigational Site Number : 0360002
Richmond, Victoria, Australia
Hospital Mae de Deus- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002
São Paulo, São Paulo, Brazil
Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001
Rio de Janeiro, Brazil
...and 27 more locations