Authors' objectives: Daratumumab in combination with lenalidomide and dexamethasone is intended to be used for the treatment of relapsed or refractory multiple myeloma. If licensed, daratumumab will offer an additional treatment option for this patient group. Patients who experience relapse after treatment with lenalidomide and bortezomib have a particularly poor prognosis. Daratumumab is a humanised IgG1K monoclonal antibody targeted at CD38, an antigen highly expressed in multiple myeloma cells. Through binding to this antigen, daratumumab mediates the activation of antibody-dependent cellular and complement-dependent cytotoxicity to stimulate the immune system to more effectively kill tumour cells. Daratumumab does not currently have Marketing Authorisation in the EU for any indication. In 2011, 4,792 people were diagnosed with multiple myeloma in England and Wales, representing a crude incidence of 9 per 100,000 population. In 2009, it was estimated that 39% of patients with multiple myeloma had relapsed disease and 65% of patients with relapsed multiple myeloma had received two or more prior therapies. Myeloma is the 16th most common cause of cancer death in the UK, accounting for 2% of all deaths from cancer. In 2013, there were 2,449 deaths from myeloma in England and Wales; 1,333 (54%) in men and 1,116 (46%) in women. Treatment options for patients with relapsed or refractory multiple myeloma include hematopoietic cell transplantation, rechallenge of the previous chemotherapy regimen, or a trial of a new regimen. Following first relapse, patients are likely to be offered further combination therapy including bortezomib and dexamethasone (+/- cyclophosphamide) or lenalidomide and dexamethasone. Daratumumab with lenalidomide and dexamethasone is currently in two phase III clinical trials comparing its effect on progression-free survival against treatment with lenalidomide and dexamethasone. These trials are expected to complete in 2017.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/daratumumab-with-lenalidomide-and-dexamethasone-for-relapsed-or-refractory-multiple-myeloma/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Centre (NIHR HSC)