Daratumumab (Darzalex®) in combination with bortezomib, melphalan and prednisone for untreated myeloma

Rothschedl E
Record ID 32018000313
Authors' results and conclusions: The addition of daratumumab to the standard combination treatment of bortezomib, melphalan and prednisone in untreated multiple myeloma (MM) patients resulted in a statistically significant benefit with a lower risk of disease progression or death, prolongation of progression-free survival (PFS) across all subgroups and a higher rate of negative status for minimal residual disease (MRD). These benefits need to be weighed against higher rates of infections and the occurrence of experienced infusion-related reactions (IRRs) among patients receiving daratumumab. Furthermore, the costs for a four-drug regimen and the required concurrent medication have to be considered. Since no further valid overall survival (OS) data can be expected and quality of life data is lacking, the clinical benefit of the assessed intervention remains to be proven. Finally, more robust evidence, particularly for the use of daratumumab as front-line treatment of MM is needed, as well as the investigation of appropriate and feasible combination regimens.
Project Status: Completed
Year Published: 2018
URL for additional information: http://eprints.aihta.at/1161/
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Therapeutics
  • Multiple Myeloma
  • Hemic and Immune Systems
  • Pharmacology
  • Antibodies, Monoclonal
  • Antineoplastic Combined Chemotherapy Protocols
  • Bortezomib
  • Melphalan
  • Prednisone
  • Disease-Free Survival
  • Survival Rate
  • Daratumumab
  • Darzalex┬«
  • multiple myeloma
  • first-line therapy
  • anti CD38 antibody
Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
Contact Name: tarquin.mittermayr@aihta.at
Contact Email: office@aihta.at
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.