Open-label study of Elotuzumab in Relapsed Multiple Myeloma

• Research type

  Research Study

• Full title

  A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed Multiple Myeloma

• IRAS ID

  37867

• Contact name

  Gareth Morgan

• Eudract number

  2007-006677-83

• Clinicaltrials.gov Identifier

  NCT00742560

• Research summary

  This is a Phase 1b/2, multicenter, open-label, dose-escalation study of Elotuzumab in combination with Lenalidomide and Dexamethasone in Subjects with Relapsed Multiple Myeloma. There are two phases to the study. The objective of the phase 1 portion is to identify the maximum tolerated dose of elotuzumab given in combination with lenalidomide and dexamethasone in subjects with relapsed multiple myeloma. The objective of the phase 2 portion is to evaluate the efficacy of elotuzumab given in combination with lenalidomide and dexamethasone in subjects with multiple myeloma after 1 to 3 prior therapies. The Phase 1 portion of the study will take place at approximately 5 to 8 sites in the United States of America (USA) and France. The Phase 2 portion of the study will have up to 20 sites in USA, Canada, France, Germany and the United Kingdom. Up to 33 subjects will be enrolled in the Phase 1 portion of the study. Approximately 60 subjects will be randomized in a 1:1 ratio to either 10 or 20 mg/kg elotuzumab dose group in the Phase 2 portion of the study.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/11

• Date of REC Opinion

  26 Mar 2010

• REC opinion

  Further Information Favourable Opinion