Combination therapy with isatuximab in patients with multiple myeloma
Research type
Research Study
Full title
Randomized, open label, multicentre study assessing the clinical benefit of isatuximab combined with carflizomib (Kyprolis®) and dexamethasone versus carfilzomib with dexamethasone in patients with relapsed and/or refractory multiple myeloma previously treated with 1 to 3 prior lines.
IRAS ID
232414
Contact name
James Griffin
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2017-001940-37
Duration of Study in the UK
5 years, 10 months, 2 days
Research summary
Isatuximab (SAR650984) is a type of drug called a monoclonal antibody (a type of protein) for use in patients with multiple myeloma. Multiple myeloma is a cancer of the blood cells where an abnormal protein is produced that damages kidneys and other organs. Myeloma can be treated effectively but cannot yet be cured.
Isatuximab binds to myeloma tumour cells, helping the body’s own immune system to kill them. The purpose of this study is to assess the effectiveness and the side effects of isatuximab when given in combination with carfilzomib and low-dose dexamethasone compared to carfilzomib and low-dose dexamethasone alone.
The blood levels of isatuximab, patients' immune response to the drug, the effect of the drug on disease progression and circulating biomarkers, and the effect of the drug on patients' quality of life will also be assessed. If patients consent, their DNA (genetic material) and how it affects the way they react to and handle the drug, and non-genetic analysis related to multiple myeloma, may also be studied.
The study will include around 300 patients with multiple myeloma, about 8 of whom will be from the UK. Participants will receive isatuximab by intravenous infusion (through the vein). Carfilzomib will be given by intravenous infusion and lowdose
dexamethasone will be taken by mouth or given by intravenous infusion. The intravenous infusions will be given at the hospital but when there are no hospital visits the oral low-dose dexamethasone can be taken by the patients at their home. The participants can continue to take the study medication unless their disease worsens, they have side effects that are considered unacceptable, or they or their doctor decide not to continue treatment.A pharmaceutical company (Sanofi) is sponsoring this study.
The study is planned to take place in 3 NHS centres in England.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/1865
Date of REC Opinion
13 Dec 2017
REC opinion
Further Information Favourable Opinion