ITHACA
Research type
Research Study
Full title
A Phase 3 randomized, open label, multicenter study of isatuximab (SAR650984) in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma.
IRAS ID
276533
Contact name
Christelle Merlo
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2019-003139-47
Duration of Study in the UK
13 years, 3 months, 1 days
Research summary
Smouldering multiple myeloma (SMM) is a pre-cancerous condition in which there is an abnormality in a blood cell called a plasma cell. The condition carries the risk of developing into an active cancer (malignancy) called multiple myeloma which is not curable. The current practices for the management of SMM is to observe and monitor for any signs of progression to multiple myeloma which would require treatment. Recent research has shown that certain patients with SMM are at higher risk than others in progressing to multiple myeloma and these patients may benefit from early treatment to prevent the progression to this stage of multiple myeloma. Various treatment options are being investigated including a therapy called monoclonal antibody therapy. This therapy consists of an antibody which is a specialised protein that can target another specific protein to treat a specific condition. In the case of SMM and multiple myeloma the antibody therapy would target a protein called CD38 which is associated with these conditions and is present on the surface of abnormal plasma cells called myeloma cells. Isatuximab, the study drug, is a monoclonal antibody therapy which targets CD38 and has been shown to be effective in treating patients with these conditions associated with CD38. In this study we will investigate the effects of isatuximab used in combination with other therapies called lenalidomide and dexamethasone which have been shown to be effective in managing patients with SMM.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0081
Date of REC Opinion
5 May 2020
REC opinion
Further Information Favourable Opinion