Date: 2012-12-10
Type of information:
phase: 1
Announcement:
Company: Sanofi (France)
Product: SAR650984 (antiCD38 monoclonal antibody)
Action mechanism: SAR650984 is an investigational naked monoclonal antibody that selectively binds to CD38 and disrupts intracellular signaling in preclinical studies.
Disease: relapsed or refractory multiple myeloma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This Phase 1b study of SAR650984 (Anti-CD38 mAb) will evaluate the safety, including immunogenicity, of SAR650984 in combination with lenalidomide in relapse or refractory multple myeloma. The severity, frequency and incidence of all toxicities will be assessed. The study duration for an individual patient will include a screening period for inclusion of up to 21 days, and at least 4 weeks of treatment in the absence of severe adverse reaction, dose limiting toxicity or disease progression plus up to 60 days post-treatment follow up. (NCT01749969)
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