Daratumumab Monotherapy for Relapsed or Refractory Multiple Myeloma: Results of an Early Access Treatment Protocol in Europe and Russia

Abstract

Introduction: Daratumumab is a human IgGj monoclonal antibody targeting CD38. Despite the demonstrated benefit of daratumumab in multiple myeloma, not all patients have access to commercially available daratumumab. Here we report a pooled analysis of patients from the UK, Spain, Italy, and Russia enrolled in an openlabel, early access treatment protocol (EAP) that provided daratumumab (16 mg/kg) monotherapy to patients with heavily pre-treated relapsed or refractory multiple myeloma (RRMM). Methods: Intravenous daratumumab 16 mg/kg was administered to patients who had received C 3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug

Rediscovering hemostasis abnormalities in multiple myeloma: The new era

“…Therefore, platelet dysfunction caused by CD38 deficiency may be the protective mechanism of VTE [ 7 ]. Furthermore, thrombocytopenia was a common adverse event with the DARA regimen, which may also be responsible for the low incidence of VTE [ 7 , [77] , [78] , [79] ]. At present, the mechanism of thrombocytopenia caused by dara has not been elucidated, but several hypotheses of CD20 monoclonal antibodies (rituximab) causing thrombocytopenia have been reported, which we speculate may be similar to the mechanism caused by dara: (1) rituximab triggers complement activation through C1q and leads to the destruction of platelet.…”