Combination therapy with isatuximab in patients with multiple myeloma
Research type
Research Study
Full title
A phase 3 randomized, open-label, multicenter study comparing isatuximab (SAR650984) in combination with pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma
IRAS ID
218114
Contact name
Kwee Yong
Contact email
Sponsor organisation
Sanofi-aventis recherche & développement
Eudract number
2016-003097-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1180-6262, WHO universal trial number
Duration of Study in the UK
4 years, 2 months, 5 days
Research summary
Isatuximab (or SAR650984) is a type of drug called monoclonal antibody (a type of protein) for 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 not yet 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 pomalidomide and low-dose dexamethasone compared to pomalidomide 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 about 300 patients with multiple myeloma, about 10 of whom will be from the UK. Participants will receive isatuximab by intravenous infusion (through the vein). Pomalidomide will be taken by mouth and low-dose dexamethasone will either 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 pomalidomide and 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 part in 3 NHS centres in England.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0033
Date of REC Opinion
7 Feb 2017
REC opinion
Favourable Opinion