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Subcutaneous daratumumab (DARA SC) versus active monitoring in patients (pts) with high-risk smoldering multiple myeloma (SMM): Randomized, open-label, phase 3 AQUILA study
No full textBackground: Standard of care for SMM includes active monitoring until progression to multiple myeloma (MM); however, recent evidence suggests pts with high-risk features may benefit from early treatment. DARA is a human IgGκ monoclonal antibody targeting CD38 that is approved as monotherapy for relapsed/refractory MM (RRMM) or in combination with standard of care for RRMM or newly diagnosed MM. Results from the phase 3 COLUMBA study showed that DARA SC demonstrated similar efficacy to intravenous (IV) DARA but with a lower rate of infusion-related reactions and shorter administration time. Based on the promising single-agent activity observed with IV DARA in intermediate- or high-risk SMM pts during the phase 2 CENTAURUS study, we hypothesized that DARA SC may delay progression to MM versus active monitoring in pts with high-risk SMM. Methods: AQUILA is an ongoing, randomized, open-label, multicenter phase 3 study of DARA SC versus active monitoring in pts with high-risk SMM. DARA SC (DARA 1,800 mg + recombinant human hyaluronidase PH20 [rHuPH20; 2,000 U/mL; Halozyme]) is administered by manual injection over approximately 5 minutes at alternating locations on the abdomen weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and every 4 weeks thereafter until 39 cycles (28 days/cycle), up to 36 months, or until disease progression. Eligibility criteria include confirmed diagnosis of SMM for ≤5 years, factors indicating high risk of progression to MM (clonal bone marrow plasma cells [BMPCs] ≥10% and ≥1 of the following: serum M protein ≥30 g/L, IgA SMM, immunoparesis with reduction of 2 uninvolved Ig isotypes, serum involved:uninvolved free light chain ratio ≥8 to 50% to < 60% with measurable disease), and ECOG performance status ≤1. The primary endpoint is progression-free survival (PFS), assessed by an independent review committee, with disease progression defined according to International Myeloma Working Group diagnostic criteria for MM. Secondary endpoints include time to biochemical or diagnostic (SLiM-CRAB) progression, overall response rate, complete response rate, duration of response, time to response, time to first-line treatment for MM, PFS on first-line treatment for MM (PFS2), overall survival, and incidence of MM with adverse prognostic features. The study completed enrollment on May 6, 2019; 390 pts have been randomly assigned to DARA SC or active monitoring. The primary efficacy analysis will be performed after approximately 165 PFS events have been observed
Emergence and genomic characterization of the first reported optrA-carrying linezolid-resistant enterococci isolated from retail broiler meat in the United Arab Emirates
Get PDFThe foodborne transfer of resistant genes from enterococci to humans and their tolerance to several commonly used antimicrobials are of growing concern worldwide. Linezolid is a last-line drug for managing complicated illnesses resulting from multidrug-resistant Gram-positive bacteria. The optrA gene has been reported in enterococci as one of the acquired linezolid resistance mechanisms. The present study uses whole-genome sequencing analysis to characterize the first reported isolates of linezolid-resistant E. faecium (n = 6) and E. faecalis (n = 10) harboring the optrA gene isolated from samples of supermarket broiler meat (n = 165) in the United Arab Emirates (UAE). The sequenced genomes were used to appraise the study isolates’ genetic relatedness, antimicrobial resistance determinants, and virulence traits. All 16 isolates carrying the optrA gene demonstrated multidrug-resistance profiles. Genome-based relatedness classified the isolates into five clusters that were independent of the isolate sources. The most frequently known genotype among the isolates was the sequence type ST476 among E. faecalis (50% (5/10)). The study isolates revealed five novel sequence types. Antimicrobial resistance genes (ranging from 5 to 13) were found among all isolates that conferred resistance against 6 to 11 different classes of antimicrobials. Sixteen different virulence genes were found distributed across the optrA-carrying E. faecalis isolates. The virulence genes in E. faecalis included genes encoding invasion, cell adhesion, sex pheromones, aggregation, toxins production, the formation of biofilms, immunity, antiphagocytic activity, proteases, and the production of cytolysin. This study presented the first description and in-depth genomic characterization of the optrA-gene-carrying linezolid-resistant enterococci from retail broiler meat in the UAE and the Middle East. Our results call for further monitoring of the emergence of linezolid resistance at the retail and farm levels. These findings elaborate on the importance of adopting a One Health surveillance approach involving enterococci as a prospective bacterial indicator for antimicrobial resistance spread at the human–food interface
Evaluation of the likelihood of establishing false codling moth (Thaumatotibia leucotreta) in Australia via the international cut flower market
Get PDFKenya and some other African countries are threatened by a serious pest Thaumatotibia leucotreta (Meyrick) (Lepidoptera: Tortricidae), the false codling moth. The detection of T. leucotreta is quite difficult due to the cryptic nature of the larvae during transportation and is therefore a concern for Australia. This insect is a known pest of agriculturally important crops. Here, Maxent was used to assess the biosecurity threat of T. leucotreta to Australia. Habitat suitability and risk assessment of T. leucotreta in Australia were identified based on threatened areas under suitable climatic conditions and the presence of hosts in a given habitat. Modeling indicated that Australia is vulnerable to invasion and establishment by T. leucotreta in some states and territories, particularly areas of western and southern Australia. Within these locations, the risk is associated with specific cropping areas. As such, invasion and establishment by T. leucotreta may have serious implications for Australia’s agricultural and horticultural industries e.g., the fruit and vegetable industries. This study will be used to inform the government and industry of the threat posed by T. leucotreta imported via the cut flower industry. Targeted preventative measures and trade policy could be introduced to protect Australia from invasion by this pest
Elastic tubes: the ideal equipment for telehealth exercise medicine in the management of prostate cancer?
Get PDFProstate cancer (PCa) affects 1 in 8 men, but exercise therapy has been shown to be a very effective intervention not only to induce physiological benefits but to also reduce the side effects of cancer treatments typically administered during PCa. The COVID19 pandemic has restricted access to exercise clinics, a problem which always existed for people living in rural and remote areas. This caused many exercise physiologists and researchers to transition their clinic-based exercise to online, home-based exercise. We would like to propose that researchers and exercise physiologists should consider the use of elastic tubes in both research and the clinical management of PCa, when exercise programs are administered remotely, as their characteristics make them an ideal exercise equipment. In this article, the characteristics, considerations, and information on quantifying exercise dosage when using elastic tubes in remote exercise delivery are discussed
The impact of student and peer behaviour on EFL teachers' motivation and job satisfaction in a Saudi Arabian context
Get PDFThis article investigates the effect that students and peers, their behaviours, and the way classes are practically and physically taught affect teachers’ motivation and job satisfaction in a Saudi Arabian context. A lack of trained teachers, unawareness of the cultural differences between their home country and that of Saudi Arabia, and the lack of training and induction in their working life, means it may be difficult to integrate into the workplace and, indeed, society. This has a knock on effect on their personal and professional lives, and added to the somewhat perplexing attitudes of some students and peer teachers, who for reasons including non-compliance, unwillingness and demotivation among students, as well as peer teachers who were perceived as poor, untrained and uncooperative, can make time at work within the Kingdom difficult, unrewarding and lonely. This results in many teachers feeling unappreciated, demotivated and demoralised, and they have little satisfaction in the job they are doing
Editorial: Managing physiological and biomechanical load-adaptation pathways in high performance sport: Challenges and opportunities
Get PDFHigh performance sport is continuing to push the barriers of elite athletes' physiological and biomechanical adaptation in an effort to gain an edge in highly competitive sporting environments, where the winning margins can be extremely thin. Methods for individualizing and optimizing the load-adaptation relationship to different training interventions have long been sought (1, 2), and continue to this day (3, 4). But while physiological adaptations to training have been well-studied, differentiating between physiological and biomechanical load-adaptation pathways is vital for understanding how best to optimize individualized training programs (5). Also of significant interest is the use of ergogenic aids such as dietary supplements (6), environmental manipulation (7), or sophisticated footwear designs (8) on physiological and biomechanical training adaptations, respectively. In addition to understanding load-adaptation pathways, and of equal importance, is determining rigorous methodology for assessing training load, so that the load-adaptation relationship can be better quantified (9, 10). However, despite the growing interest in training and ergogenic intervention research, there remains much to be learnt about assessing and managing the load-adaptation pathway within elite athlete populations
Letter writing and critical Self-Reflection: An insiders account of academic casualisation in the Australian Neoliberal University
No full textSharing the lived experience of academic casualisation is challenging, based on a power imbalance with many oppositional points, including cost savings versus fair wages, precarity versus security. As researcher/participant, Jennifer initially struggled with sharing experiences emotionally and academically without stripping humanity and affect from her writing. Drawing on the tradition of critical autoethnography, this article uses letter writing as a means of investigating personal-professional experience through critical self-reflection. These letters are written to a fictional colleague (Q) for the purpose of ‘wondering aloud’ about her experience of casualised labour and the difficulties of constructing a personal-professional identity within the context of the Australian neoliberal university
Information processing biases: The effects of negative emotional symptoms on sampling pleasant and unpleasant information.
No full textAlthough theories of emotion associate negative emotional symptoms with cognitive biases in information processing, they rarely specify the details. Here, we characterize cognitive biases in information processing of pleasant and unpleasant information, and how these biases covary with anxious and depressive symptoms, while controlling for general stress and cognitive ability. Forty undergraduates provided emotional symptom scores (Depression Anxiety Stress Scale–21) and performed a statistical learning task that required predicting the next sound in a long sequence of either pleasant or unpleasant naturalistic sounds (blocks). We used an information weights framework to determine if the degree of behavioral change associated with observing either confirmatory (“B” follows “A”) or disconfirmatory (“B” does not follow “A”) transitions differs for pleasant and unpleasant sounds. Bayesian mixed-effects models revealed that negative emotional symptom scores predicted performance as well as processing biases of pleasant and unpleasant information. Further, information weights differed between pleasant and unpleasant information, and importantly, this difference varied based on symptom scores. For example, higher depressive symptom scores predicted a bias of underutilizing disconfirmatory information in unpleasant content. These findings have implications for models of emotional disorders by offering a mechanistic explanation and formalization of the associated cognitive biases
Membrane fouling control for sustainable microalgal biodiesel production: A review
No full textMicroalgae have the potential to be an excellent source of sustainable and renewable biofuel. However, different issues surrounding their economic viability and upscale application need to be resolved. Microalgal dewatering requires substantial energy to concentrate the highly dilute microalgal culture and is considered a major bottleneck that limits industrial mass production. Compared to traditional microalgal dewatering processes, membrane technology offers many advantages such as lower energy consumption, simple operation, reduced chemical usage, and scaling-up capability. Membranes can also be used in biodiesel separation and purification, which is a very important step to achieve a finished biodiesel product that complies with the international standards and specifications (e.g., free glycerol limit of 0.02 mass%). The use of membrane filtration in the biodiesel refining process is a promising technology to reduce the water usage and wastewater disposal required in the conventional water-washing process and to avoid non-recyclable solvents used in the dry-washing process. However, the main challenge in membrane application is fouling, which has adverse effects such as flux reduction and increased cleaning frequency. Hence, the development of environment-friendly, low-cost and anti-fouling membranes is paramount to reduce the costs and energy consumption to feasible levels for both microalgal dewatering and biodiesel refining processes. This review discusses the challenges that hinder the economical production of microalgal biofuels at commercial-scale and identifies strategies for mitigating membrane-fouling in order to optimize the economics of algal biomass production and downstream processing
Mangrove-shrimp farming: A triple-win approach for communities in the Mekong River Delta
No full textBalancing economic, environmental and social objectives usually challenges policymakers, but it is feasible. Using a unique household survey dataset with 98 households in Ca Mau Province, Vietnam, we found that integrating mangroves with shrimp farming, in a mangrove-aquaculture system (MAS), can support multiple objectives. The MAS provides the highest average benefit-cost ratio (BCR), from 2.7 to 2.9, while the BCR of surveyed intensive shrimp farms ranged from 1.1 to 1.2, and that of the traditional extensive shrimp farming systems was from 1.7 to 1.8. MAS was also the least expensive in terms of investment and suitable for people with limited financial capacity. MAS can also produce other economic and environmental benefits, such as from carbon mitigation, with less overall risk than the other systems. Our survey data show that mangrove coverage may contribute to economic efficiency; and the optimal mangrove coverage from the perspective of individual farmers (30%) was lower than what is demonstrated by empirical data (60%). While our findings draw from survey data in a specific location, they highlight the benefits of MAS as a possible triple-win approach towards sustainable development and also emphasise the importance of complementary programs, such as awareness enhancement, communication, and training