Sanofi’s ICARIA-MM trial was designed to investigate if isatuximab could delay disease progression or death among multiple myeloma patients who had failed prior lines of treatment. The duration of the study for the patients was to include a period for screening of up to 21 days (or up to 28 days for women who can become pregnant). Patients would continue study treatment until disease progression, unacceptable adverse reaction, patients’ wish or other reason of discontinuation. During follow-up, patients who discontinue the study treatment due to progression of the disease will be followed every 3 months (12 weeks) for survival (or until cut- off date), and patients who discontinue the study treatment prior to documentation of disease progression will be followed-up every 4 weeks until disease progression, and then every 3 months (12 weeks) for survival (or until cut-off date). According to the trial results, isatuximab added to a standard of care treatment of pomalyst (pomalidomide) and low-dose dexamethasone prolonged the time without cancer progression in adults with relapsed or refractory multiple myeloma.
Isatuximab is an antibody that targets the CD38 protein, a cell surface molecule highly expressed by multiple myeloma cells. After blinding to its target, isatuximab engages the immune system into fighting these cells.Source: ClinicalTrials