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

Chari, Ajai; Munder, Markus; Weisel, Katja; Jenner, Matthew; Bygrave, Ceri; Petrucci, Maria; Boccadoro, Mario; Cavo, Michele; van de Donk, Niels; Turgut, Mehmet; DEMİRKAN, FATİH; Karadogan, Ihsan; Libby, Edward; Kleiman, Robert; Kuppens, Steven; Bandekar, Rajesh; Neff, Tobias; Heuck, Christoph; Qi, Ming; Clemens, Pamela; Goldschmidt, Hartmut

doi:10.1007/s12325-020-01601-w

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

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, Scopus)

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
Açık Arşiv Koleksiyonu: AVESİS Açık Erişim Koleksiyonu
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.