articleNew England Journal of MedicineAug 24, 2016BRONZE OA

Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma

Johannes Gutenberg University Mainz · Cornell University · +20 more institutions

PubMed
Indexed incrossrefpubmed

Abstract

Background

Daratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients with multiple myeloma, as well as in combination with bortezomib in patients with newly diagnosed multiple myeloma.

Methods

In this phase 3 trial, we randomly assigned 498 patients with relapsed or relapsed and refractory multiple myeloma to receive bortezomib (1.3 mg per square meter of body-surface area) and dexamethasone (20 mg) alone (control group) or in combination with daratumumab (16 mg per kilogram of body weight) (daratumumab group). The primary end point was progression-free survival.

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