Lancet Haematol: Can the new target drug replace the transplantation of self-producing hematopoietic stem cells?

The emergence of highly active new drugs has led some to question the role of self-gene stem cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myelomaThe purpose of this study was to compare the efficacy of the enhanced therapy of the hSCT and the boronzozomi-mefaren-Punisson (VMP) and the enhanced therapy of botozozomi-Lenamamine-dexamethasone (VRD)this study is a randomized, open Phase 3 clinical trial that recruited patients aged 18-65, untreated, and asymptomatic stage 1-3 multiple myeloma (EHO performance level 0-2) from 172 centersPatients were subjected to two random groupings, the first being 1:1 to the self-contained HSCT group or VMP group, and the second being 1:1 to the VRD consolidation group or the non-consolidated groupThe main endpoint is the progression-free survival after each random grouping25 February 2011 - April 3, 2014, a total of 1,503 patients were recruited1197 entered the first random group, of which 702 were assigned to the self-contained HSCT group, 495 were divided into vMP group, and 877 patients in the second group participated in the second group, of which 449 were assigned to the VRD consolidation group and 428 to the non-consolidated groupAs of November 26, 2018, the median progression survival in patients in the self-contained HSCT group was significantly increased compared to the VMP group (56.7 vs 41.9 months, HR 0.73, p.0001)For secondary groupings, the number of progressor deaths at the due date is lower than expected in the final analysis, so this result is derived from the second scheduled mid-term analysis, i.ewhen progress or deaths reach 66 per centMedian progression survival was significantly longer (58.9 vs 45.5 months, HR 0.77, p.014) in patients with VRD as consolidation therapy at 42.1 months compared to patients without consolidation therapyThe most common adverse events of level 3 and above in the self-contained HSCT group and VMP group were neutrope% reduction (79% vs 29%), platelet reduction (83% vs 16%), gastrointestinal disease (12% vs 5%) and infection (30% vs 4%), and 239 (34%) and 135 (27%) of patients, respectively, had at least one severe adverse reaction eventInfection was the most common adverse reaction event in each group (56% vs 37%)Of the 311 deaths from the first randomized group, 38 (12%) were related to treatment: 26 (68%) in the autonomous HSCT group, 12 (32%) in the VMP group, the most common causes of death were infection (8 cases (21%), heart events (6 cases (16%) and secondary malignancies (20 cases (53%))this study supports the use of self-contained HSCT as intensive and consolidation therapy in newly diagnosed patients with multiple myeloma, even in the new drug era