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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
* 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
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
Start Date
April 5, 2023
Primary Completion Date
November 30, 2026
Completion Date
November 30, 2026
Last Updated
January 23, 2025
70
ESTIMATED participants
Isatuximab intravenous (IV)
DRUG
Cemiplimab (SAR439684)
DRUG
Dexamethasone
DRUG
Lenalidomide
DRUG
Pomalidomide
DRUG
Isatuximab subcutaneous (SC)
DRUG
Carfilzomib
DRUG
Lead Sponsor
Sanofi
NCT06356571
NCT05334069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05312255