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
Sanofi
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent. * Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed. * Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a…
Interventions
- DrugIsatuximab intravenous (IV)
Route of administration: IV infusion; Pharmaceutical form: Vial
- DrugCemiplimab (SAR439684)
Route of administration: IV infusion; Pharmaceutical form: Vial
- DrugDexamethasone
Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
- DrugLenalidomide
Route of administration: Oral; Pharmaceutical form: Capsules
- DrugPomalidomide
Route of administration: Oral; Pharmaceutical form: Hard capsules
- DrugIsatuximab subcutaneous (SC)
Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
- DrugCarfilzomib
Route of administration: IV infusion; Pharmaceutical form: Vial
Locations (37)
- Washington University- Site Number : 8400001St Louis, Missouri
- Investigational Site Number : 0360006Blacktown, New South Wales
- Investigational Site Number : 0360001Saint Leonards, New South Wales
- Investigational Site Number : 0360003Wollongong, New South Wales
- Investigational Site Number : 0360004Melbourne, Victoria
- Investigational Site Number : 0360005Melbourne, Victoria