Characterization of Haematological Parameters with Bortezomib–melphalan–prednisone Versus Melphalan–prednisone in Newly Diagnosed Myeloma, with Evaluation of Long‐term Outcomes and Risk of Thromboembolic Events with Use of Erythropoiesis‐stimulating Agents: Analysis of the VISTA Trial

SummaryAlthough haematological toxicities, such as anaemia, are common in multiple myeloma (MM), no clear consensus exists on the use and impact of erythropoiesis‐stimulating agents (ESA) on outcomes in MM. This analysis characterizes haematological toxicities and associated interventions in the phase III VISTA (Velcade® as Initial Standard Therapy in Multiple Myeloma: Assessment with Melphalan and Prednisone) study of bortezomib plus melphalan/prednisone (VMP, n = 344) versus MP (n = 338) in previously untreated MM patients ineligible for high‐dose therapy, and evaluates the impact of ESA use or red‐blood‐cell (RBC) transfusions on outcomes and thromboembolic risk. Incidence of haematological toxicities was similar with VMP and MP; similar rates of interventions and associated complications (e.g. bleeding, febrile neutropenia) were observed. Two hundred thirty three patients received ESA; 204 had RBC transfusions. Frequency of thromboembolic events was low and not affected by ESA use. Median time‐to progression (TTP) was similar between ESA/non‐ESA [hazard ratio: 1·03 (95% confidence interval 0·76–1·39); P = 0·8478] in both arms (VMP: 19·9/not reached; MP: 15·0/17·5 months). Three‐year overall survival (OS) rates were similar between ESA/non‐ESA in each arm. Patients receiving RBC transfusions had significantly shorter OS (P < 0·0001) versus non‐RBC‐transfusion patients. In conclusion, bortezomib did not add to melphalan haematological toxicity. Concomitant ESA use with VMP/MP in previously untreated MM patients did not adversely affect TTP or OS, or increase thromboembolic risk. However, RBC transfusion was associated with significantly shorter survival.