Evaluation of the safety and efficacy of daratumumab outside of clinical trials

Hiroki Kobayashi, Takafumi Tsushima, Toshiki Terao, Yoshiaki Abe, Daisuke Miura, Kentaro Narita, Akihiro Kitadate, Masami Takeuchi, Kosei Matsue

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)


Daratumumab-based therapy has been shown to have significant clinical efficacy in phase 3 trials of patients with relapse or refractory multiple myeloma. Outside of clinical trials, however, clinical data on daratumumab remain limited. We reviewed medical records of patients who received daratumumab combination therapy at our institute (median age 74 years; median lines of prior therapy 4). The overall response rate was 69.4%, and 36.7% of patients achieved complete response (CR) or better. The proportion of patients who attained CR or better was significantly higher among patients with < 4 prior therapies than those with ≥ 4 (56.5% vs 19.2%, P = 0.009). Estimated median progression-free survival (PFS) was 12.4 months (95% confidence interval 8.6—not reached). The median PFS was significantly worse in patients who were refractory to bortezomib and lenalidomide and had received ≥ 4 lines of prior therapy. Twelve of 49 patients attained negative minimal residual disease. Common adverse events included hematological toxicities including neutropenia and lymphopenia; however, the rate of febrile neutropenia was low (3.8%). Infusion-related reactions occurred in 32.1% of patients, but were grade 1 or 2. Daratumumab combination therapies therefore appear to be effective and safe as salvage regimens in clinical practice, especially when used in the early phase.

Original languageEnglish
Pages (from-to)665-672
Number of pages8
JournalInternational journal of hematology
Issue number6
Publication statusPublished - Jun 20 2019
Externally publishedYes


  • Bortezomib
  • Daratumumab
  • Lenalidomide
  • Multiple myeloma

ASJC Scopus subject areas

  • Hematology


Dive into the research topics of 'Evaluation of the safety and efficacy of daratumumab outside of clinical trials'. Together they form a unique fingerprint.

Cite this