Clinical Research

Background While going through the literatures, I came across two landmark articles on the evolution of Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Multiple Myeloma (SMM) by the Mayo Clinic Group headed by Dr Robert Kyle. These articles described the evolution of MGUS and SMM into symptomatic myeloma by reporting cumulative proportion of developing symptomatic myeloma in a population based follow up study. The following figure depicts the progression of MGUS into symptomatic myeloma

Introduction Practicing Evidence Based Medicine (EBM) has become the norm in Clinical Medicine for past few decades. Generating evidences by carrying out and publishing clinical research of various types (clinical trials, observational studies) have become a norm. It has been observed that around 80% of the clinical research findings and interpretations are not replicable, implicating that wrong clinical decisions are made based on the false findings. Major factors contributing to false results are biases created by researcher, editorial boards of journals and mis-interpretation of statistical terminologies.

Study The study in question is the ALCYONE Trial, published in NEJM in 12 December 2017 by María-Victoria Mateos, Meletios A Dimopoulos, et al. The investigators studied the effect of adding Daratumumab with Bortezomib, Melphalan and Prednisolone in patients with freshly detected Myeloma ineligible for Autologous Bone Marrow Transplantation. The study arms were Arm 1: Daratumumab + Bortezomib + Melphalan + Prednisolone and Arm 2: Bortezomib + Melphalan + Prednisolone