...Patients will be randomized to treatment using the Pocock-Simon algorithm balancing the distribution of the following stratification factors between the two treatment arms: 1) ISS 1-2 disease vs. ISS 3 disease (current ISS stage based off screening beta 2 microglobulin and albumin) 2) High risk cytogenetics features: yes vs. no High risk cytogenetics features include: del(1p), gain of 1q, t(4;14), t(14;16), t(14; 20), del(17p) 3) Prior treatment with a proteasome inhibitor: yes vs. no...

...Patients with a confirmed diagnosis of symptomatic multiple myeloma with high-risk genetic features (1q21 amplification/t(4;14)/t(14;16)/t(14;20)/17p deletion/TP53 mutation) according to IMWG 2016 criteria....

...deletion of chromosome 13 by conventional cytogenetics, hypodiploidy, abnormality in chromosome 1(1q amplification or 1p deletion), t(4;14), t(14;16), t(14;20) or deletion of 17p by fluorescence in situ hybridization (FISH) or conventional karyotyping; high risk criteria based on commercially available gene expression profiling (GEP) b....

The overall response rate (ORR) was 73.0% in the IRD cohort vs 66.2% in the RD cohort….Median OS was significantly improved in the IRD cohort (36.6 months vs 26.0 months p=0.008); in patients with 1–3 prior relapses median OS was not yet reached for the IRD cohort (NR vs 27.1 months p=0.002). A higher percentage of patients in the IRD cohort were still alive at 6 months (88.9% vs 83.4%), 12 months (76.8% vs 71.5%), and 24 months (66.4% vs 52.7%),...High-risk features as defined by the presence at least one cytogenetic abnormality including t(4;14), t(14;16), or del(17p13) were present in 11.8% (15/127) patients in the IRD cohort and 8.8% (19/217) patients in the RD cohort. Among those patients in the IRD cohort whose disease was considered high-risk, one patient reached VGPR, six reached PR, four reached MR, two had stable disease (SD) and two progressed (PD).