Daratumumab, bortezomib, and dexamethasone for multiple myeloma

A. A. Palumbo, Asher A. Chanan-Khan, Katja Weisel, Ajay K. Nooka, T. Masszi, M. Beksac, Ivan Spicka, Vania Hungria, Markus Munder, Maria Victoria Mateos, Tomer M Mark, Ming Qi, Jordan Schecter, Himal Amin, Xiang Qin, William Deraedt, Tahamtan Ahmadi, Craig A. Spencer, P. Sonneveld, Nicola Cascavilla

Research output: Contribution to journalArticlepeer-review


BACKGROUND: Daratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients with multiple myeloma, as well as in combination with bortezomib in patients with newly diagnosed multiple myeloma. METHODS: In this phase 3 trial, we randomly assigned 498 patients with relapsed or relapsed and refractory multiple myeloma to receive bortezomib (1.3 mg per square meter of body-surface area) and dexamethasone (20 mg) alone (control group) or in combination with daratumumab (16 mg per kilogram of body weight) (daratumumab group). The primary end point was progression-free survival. RESULTS: A prespecified interim analysis showed that the rate of progression-free survival was significantly higher in the daratumumab group than in the control group; the 12-month rate of progression-free survival was 60.7% in the daratumumab group versus 26.9% in the control group. After a median follow-up period of 7.4 months, the median progression-free survival was not reached in the daratumumab group and was 7.2 months in the control group (hazard ratio for progression or death with daratumumab vs. control, 0.39; 95% confidence interval, 0.28 to 0.53; P
Original languageEnglish
Pages (from-to)754-766
Number of pages13
JournalNew England Journal of Medicine
Issue number8
Publication statusPublished - 2016


  • antineoplastic agent
  • bortezomib
  • CD38 antigen
  • daratumumab
  • dexamethasone
  • monoclonal antibody
  • adult
  • aged
  • antagonists and inhibitors
  • clinical trial
  • controlled study
  • disease free survival
  • drug resistance
  • female
  • human
  • intravenous drug administration
  • male
  • middle aged
  • multicenter study
  • multiple myeloma
  • phase 3 clinical trial
  • randomized controlled trial
  • recurrent disease
  • Adult
  • Aged
  • Antibodies, Monoclonal
  • Antigens, CD38
  • Antineoplastic Combined Chemotherapy Protocols
  • Bortezomib
  • Dexamethasone
  • Disease-Free Survival
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Multiple Myeloma
  • Recurrence


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