Annals of hematology
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Annals of hematology · Nov 2017
Randomized Controlled Trial Multicenter StudyBortezomib and low-dose dexamethasone with or without continuous low-dose oral cyclophosphamide for primary refractory or relapsed multiple myeloma: a randomized phase III study.
This phase III, open-label, randomized, controlled study aimed to evaluate the benefit of adding continuous low-dose oral cyclophosphamide to bortezomib-dexamethasone in patients with primary relapsed/refractory multiple myeloma. Patients were randomized 1:1 to receive up to eight 3-week cycles of bortezomib (1.3 mg/m2) and dexamethasone (20 mg; VD; n = 48) or bortezomib-dexamethasone plus oral cyclophosphamide (50 mg; VCD; n = 48). Median time to progression (primary endpoint) was slightly longer in the VD versus VCD group (12.6 vs 9.9 months, P = 0.192), and the hazard ratio for disease progression was in favor of VD (hazard ratio = 0.71, 95% confidence interval = 0.43-1.19, P = 0.196). ⋯ Further trials are needed to determine whether addition of cyclophosphamide to VD at a different dose/schedule confers clinical benefit. This study was terminated prematurely, with insufficient sample size to adequately compare the arms; the results should, therefore, be considered descriptive. This trial is registered: EudraCT Number 2008-003213-27; ClinicalTrials.gov NCT00813150.
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Annals of hematology · Nov 2017
Life-threatening bleeding episodes in primary immune thrombocytopenia: a single-center retrospective study of 169 inpatients.
Bleeding is the most important clinical outcome in patients with immune thrombocytopenia (ITP), and the goal of therapy in such cases is to treat or prevent bleeding. The frequency of and risk factors for bleeding events in ITP have only recently been identified in several large-scale studies. However, there is little published information about severe life-threatening bleeding in ITP. ⋯ Hypertension, diabetes mellitus, anticoagulant use, ITP phase, and sex were not identified as strong risk factors for life-threatening bleeding. Combining age and the platelet count might be a useful way of identifying ITP patients that are at risk of life-threatening bleeding. Most intracranial hemorrhaging (4/5) was spontaneous and multifocal, suggesting that these might be characteristics of ITP-related bleeding in elderly patients.