Evaluation of Cardiac Repolarization in the Randomized Phase 2 Study of Intermediate- or High-Risk Smoldering Multiple Myeloma Patients Treated with Daratumumab Monotherapy


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Chari A., Munder M., Weisel K., Jenner M., Bygrave C., Petrucci M. T., ...Daha Fazla

ADVANCES IN THERAPY, cilt.38, sa.2, ss.1328-1341, 2021 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 38 Sayı: 2
  • Basım Tarihi: 2021
  • Doi Numarası: 10.1007/s12325-020-01601-w
  • Dergi Adı: ADVANCES IN THERAPY
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, PASCAL, BIOSIS, Biotechnology Research Abstracts, CAB Abstracts, CINAHL, EMBASE, International Pharmaceutical Abstracts, MEDLINE
  • Sayfa Sayıları: ss.1328-1341
  • Anahtar Kelimeler: Daratumumab, Monoclonal antibody, Pharmacokinetic-pharmacodynamic analysis, QTc substudy, Smoldering multiple myeloma
  • Ondokuz Mayıs Üniversitesi Adresli: Evet

Özet

Introduction: Daratumumab is a CD38-targeting monoclonal antibody that has demonstrated clinical benefit for multiple myeloma. Daratumumab inhibition of CD38, which is expressed on immune cell populations and cardiomyocytes, could potentially affect cardiac function. This QTc substudy of the phase 2 CENTAURUS study investigated the potential effect of intravenous daratumumab monotherapy on QTc prolongation and other electrocardiogram (ECG) parameters, including concentration-QTc effect modeling.