Validation of the International Myeloma Working Group standard response criteria in the PETHEMA/GEM2012MENOS65 study: are these times of change?
Ana Jiménez Ubieto, Bruno Paiva, Noemí Puig, María‐Teresa Cedena, Joaquín Martínez‐López, Albert Oriol, María‐Jesús Blanchard, Rafael Ríos, Jesús Martín, Rafael Martínez, Anna Sureda, Miguel-Teodoro Hernández, Javier de la Rubia, I. Krnisk, Valentín Cabañas, Luis Palomera, José María Sánchez‐Pina, Joan Bargay, María‐Victoria Mateos, Laura Rosiñol, Joan Bladé, Jesús F. San Miguel, Juan José Lahuerta, on behalf of the GEM (Grupo Español de Mieloma)/PETHEMA (Programa Español de Tratamientos en Hematología) Cooperative Study Group
Abstract
Induction and consolidation based on proteasome inhibitors, immunomodulatory drugs, and corticoids integrated with high-dose therapy (HDT) and autologous stem cell transplantation (ASCT), are showing complete response (CR) rates >50% in multiple myeloma (MM).1-3 The addition of anti-CD38 monoclonal antibodies may increase these unprecedented CR rates.4-6 When more than half of transplant-eligible patients with MM achieve CR with frontline therapy, it is reasonable to ask, what other tests are clinically relevant after negative immunofixation. The achievement of deep responses with modern therapy led the International Myeloma Working Group (IMWG) to propose new guidelines that included definitions of negative minimal residual disease (MRD) for standard response criteria.7 Indeed, recent studies have reported nearly 50% MRD− rates,5,8,9 and, more importantly, the prognostic value of MRD criteria was validated in clinical trials8,10-12 and routine practice....