38 research outputs found
Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): And randomised, phase 3, open-label, multicentre study
Background: Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Methods: In this randomised, phase 3, open-label, multicentre study, patients with relapsed or refractory multiple myeloma who had one to three previous treatments were randomly assigned (1:1) using a blocked randomisation scheme (block size of four) to receive carfilzomib with dexamethasone (carfilzomib group) or bortezomib with dexamethasone (bortezomib group). Randomisation was stratified by previous proteasome inhibitor therapy, previous lines of treatment, International Staging System stage, and planned route of bortezomib administration if randomly assigned to bortezomib with dexamethasone. Patients received treatment until progression with carfilzomib (20 mg/m2 on days 1 and 2 of cycle 1; 56 mg/m2 thereafter; 30 min intravenous infusion) and dexamethasone (20 mg oral or intravenous infusion) or bortezomib (1·3 mg/m2; intravenous bolus or subcutaneous injection) and dexamethasone (20 mg oral or intravenous infusion). The primary endpoint was progression-free survival in the intention-to-treat population. All participants who received at least one dose of study drug were included in the safety analyses. The study is ongoing but not enrolling participants; results for the interim analysis of the primary endpoint are presented. The trial is registered at ClinicalTrials.gov, number NCT01568866. Findings: Between June 20, 2012, and June 30, 2014, 929 patients were randomly assigned (464 to the carfilzomib group; 465 to the bortezomib group). Median follow-up was 11·9 months (IQR 9·3-16·1) in the carfilzomib group and 11·1 months (8·2-14·3) in the bortezomib group. Median progression-free survival was 18·7 months (95% CI 15·6-not estimable) in the carfilzomib group versus 9·4 months (8·4-10·4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0·53 [95% CI 0·44-0·65]; p<0·0001). On-study death due to adverse events occurred in 18 (4%) of 464 patients in the carfilzomib group and in 16 (3%) of 465 patients in the bortezomib group. Serious adverse events were reported in 224 (48%) of 463 patients in the carfilzomib group and in 162 (36%) of 456 patients in the bortezomib group. The most frequent grade 3 or higher adverse events were anaemia (67 [14%] of 463 patients in the carfilzomib group vs 45 [10%] of 456 patients in the bortezomib group), hypertension (41 [9%] vs 12 [3%]), thrombocytopenia (39 [8%] vs 43 [9%]), and pneumonia (32 [7%] vs 36 [8%]). Interpretation: For patients with relapsed or refractory multiple myeloma, carfilzomib with dexamethasone could be considered in cases in which bortezomib with dexamethasone is a potential treatment option. Funding: Onyx Pharmaceuticals, Inc., an Amgen subsidiary
Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial
Evidence of a cubic iron sub-lattice in t-CuFe2O4 demonstrated by X-ray Absorption Fine Structure
Copper ferrite, belonging to the wide and technologically relevant class of spinel ferrites, was grown in the form of t-CuFe2O4 nanocrystals within a porous matrix of silica in the form of either an aerogel or a xerogel, and com-pared to a bulk sample. Extended X-ray absorption fine structure (EXAFS) spectroscopy revealed the presence of two different sub-lattices within the crystal structure of t-CuFe2O4, one tetragonal and one cubic, defined by the Cu2+ and Fe3+ ions respectively. Our investigation provides evidence that the Jahn-Teller distortion, which occurs on the Cu2+ ions located in octahedral sites, does not affect the coordination geometry of the Fe3+ ions, regardless of their location in octahedral or tetrahedral sites
Self-control interventions for children under age 10 for improving self-control and delinquency and problem behaviors
Self-control improvement programs are intended to serve many purposes, most
notably improving self-control. Yet, interventions such as these often aim to reduce
delinquency and problem behaviors. However, there is currently no summary
statement available regarding whether or not these programs are effective in
improving self-control and reducing delinquency and problem behaviors. The main objective of this review is to assess the available research evidence on the
effect of self-control improvement programs on self-control and delinquency and
problem behaviors. In addition to investigating the overall effect of early selfcontrol
improvement programs, this review will examine, to the extent possible, the
context in which these programs may be most successful. The studies included in this systematic review indicate that self-control
improvement programs are an effective intervention for improving self-control and
reducing delinquency and problem behaviors, and that the effect of these programs
appears to be rather robust across various weighting procedures, and across context,
outcome source, and based on both published and unpublished data