Clinical Implications of Complex Pharmacokinetics for Daratumumab Dose Regimen in Patients With Relapsed/Refractory Multiple Myeloma

XS Xu, Xiaoyu Yan, Thomas A. Puchalski, Sagar Lonial, HM Lokhorst, PM Voorhees, Trine Lindhardt Plesner, Kui Liu, Imran Khan, R Jansson,

Clinical Pharmacology & Therapeutics · 2016 · 67 citations · 6 references

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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.

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