Results of a phase 3 study of daratumumab monotherapy administered subcutaneously (SC) compared with intravenous (IV) administration in patients with relapsed/refractory multiple myeloma (RRMM) showed no significant differences in efficacy or pharmacokinetic endpoints .
The IV formulation of daratumumab, a monoclonal antibody targeting CD38, has been approved as either monotherapy or in combination with standard-of-care regimens for patients with RRMM, or when combined with bortezomib/melphalan/dexamethasone for transplant-ineligible, newly diagnosed patients with MM. However, IV daratumumab is typically infused over hours and is associated with infusion reactions in a substantial percentage of patients.
In the open-label, multicentre, phase 3 COLUMBA trial, 522 adult patients with RRMM were randomly assigned in a 1:1 ratio to receive an SC formulation of daratumumab, including recombinant ...
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Table of Contents: EHA 2019
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