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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 G1? 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.

SUBMITTER: Xu XS 

PROVIDER: S-EPMC5485722 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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

Xu X S XS   Yan X X   Puchalski T T   Lonial S S   Lokhorst H M HM   Voorhees P M PM   Plesner T T   Liu K K   Khan I I   Jansson R R   Ahmadi T T   Ruixo Jj Perez JP   Zhou H H   Clemens P L PL  

Clinical pharmacology and therapeutics 20170213 6

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 regim  ...[more]

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