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., ...More

ADVANCES IN THERAPY, vol.38, no.2, pp.1328-1341, 2021 (SCI-Expanded, Scopus)

Publication Type: Article / Article
Volume: 38 Issue: 2
Publication Date: 2021
Doi Number: 10.1007/s12325-020-01601-w
Journal Name: ADVANCES IN THERAPY
Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, PASCAL, BIOSIS, Biotechnology Research Abstracts, CAB Abstracts, CINAHL, EMBASE, International Pharmaceutical Abstracts, MEDLINE
Page Numbers: pp.1328-1341
Keywords: Daratumumab, Monoclonal antibody, Pharmacokinetic-pharmacodynamic analysis, QTc substudy, Smoldering multiple myeloma
Open Archive Collection: AVESIS Open Access Collection
Dokuz Eylül University Affiliated: Yes

Abstract

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.