title: Clinical Implications of Complex Pharmacokinetics for Daratumumab Dose Regimen in Patients With Relapsed/Refractory Multiple Myeloma.
abstract: New therapeutic strategies are urgently needed to improve clinical outcomes in patients with multiple myeloma (MM). Daratumumab is a first-in-class, CD38 human immunoglobulin G1κ monoclonal antibody approved for treatment of relapsed or refractory MM. Identification of an appropriate dose regimen for daratumumab is challenging due to its target-mediated drug disposition, leading to time- and concentration-dependent pharmacokinetics. We describe a thorough evaluation of the recommended dose regimen for daratumumab in patients with relapsed or refractory MM.
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey, USA.
authors.forename: X S
authors.initials: XS
authors.lastname: Xu
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey, USA.
authors.forename: X
authors.initials: X
authors.lastname: Yan
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: T
authors.initials: T
authors.lastname: Puchalski
authors.affiliation: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia, USA.
authors.forename: S
authors.initials: S
authors.lastname: Lonial
authors.affiliation: VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: H M
authors.initials: HM
authors.lastname: Lokhorst
authors.affiliation: Division of Hematology/Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: P M
authors.initials: PM
authors.lastname: Voorhees
authors.affiliation: Vejle Hospital and University of Southern Denmark, Vejle, Denmark.
authors.forename: T
authors.initials: T
authors.lastname: Plesner
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey, USA.
authors.forename: K
authors.initials: K
authors.lastname: Liu
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey, USA.
authors.forename: I
authors.initials: I
authors.lastname: Khan
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: R
authors.initials: R
authors.lastname: Jansson
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: T
authors.initials: T
authors.lastname: Ahmadi
authors.affiliation: Janssen Research & Development, Beerse, Belgium.
authors.forename: Jj Perez
authors.initials: JP
authors.lastname: Ruixo
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: H
authors.initials: H
authors.lastname: Zhou
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: P L
authors.initials: PL
authors.lastname: Clemens
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D004334:Drug Administration Schedule; D054796:Drug Dosage Calculations; D019008:Drug Resistance, Neoplasm; D006801:Humans; D008954:Models, Biological; D009101:Multiple Myeloma / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; C556306:daratumumab