TED10893
Research type
Research Study
Full title
A Phase 1/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 In Patients with Selected CD38+ Hematological Malignancies
IRAS ID
214762
Contact name
Matthew Jenner
Contact email
Sponsor organisation
Sanofi-aventis recherche & développement
Eudract number
2013-001418-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 5 months, 1 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 by itself compared to isatuximab and dexamethasone.
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.
This part of the study will include about 160 patients with multiple myeloma, 6 of whom will be from the UK. Participants will receive isatuximab by intravenous infusion (through the vein). Dexamethasone will be either be administered orally or by intravenous infusion.
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 the study.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0156
Date of REC Opinion
7 Apr 2017
REC opinion
Favourable Opinion