ABSTRACT
This article explores medical-device related pressure ulcers (MDRPU) in an intensive care unit (ICU) at the Royal United Hospitals Bath NHS Foundation Trust (RUH). The data presented outlines a reduction in PU of 66% over a 6-year period and a reduction in MDRPU of 50% over the same period. MDRPU were particularly challenging to prevent in ICU during the COVID-19 pandemic, where there were additional numbers of patients in the ICU with medical devices in place. Additionally, during the COVID-19 pandemic, an increased number of patients in the ICU were nursed prone (face down), adding additional pressure on the facial structure, a range of measures were put in place to avoid those avoidable MDRPU in the ICU at the RUH. Measures focused on skin checking, offloading and rotation of devices, including endotracheal tubes, non-invasive ventilation, nasogastric (NG) and nasojejunal (NJ) tubes and catheters. A specific comfort and pressure care record was developed for ICU to record the assessments of these at risk areas.
ABSTRACT
Background: Systemic AL amyloidosis is an incurable relapsing plasma cell disorder. Despite therapeutic advances, there are no approved treatments for relapse disease. Treatment is often challenging due to underlying organ dysfunction. Belantamab mafodotin is an antibody-drug conjugate targeting B-cell maturation antigen with approval for relapsed refractory myeloma. In multiply pre-treated myeloma, the DREAMM-2 phase II trial showed an overall response rate of 32% for those with 2.5 mg/kg dose administered every three weeks with 2/3rd patients reporting keratopathy. A small case series of 6 patients with relapsed AL amyloidosis (Zhang et al , ASH 2021) was recently reported and a phase 2 trial is recruiting for patients with refractory amyloidosis (NCT04617925). Aims: We report our initial results using Belantamab monotherapy for the treatment of patients with AL amyloidosis with relapsed disease. Methods: Data for consecutive patients who were administered Belantamab at a specialist referral centre, National Amyloidosis Centre, University College London, was analysed. Results: Eleven patients were included 8 male, 3 female. Median age at Belantamab initiation was 65 (range 42-74) years. Eight patients had λ AL-type and three κ AL-type. At diagnosis, median involved free light-chain concentration was 534 (range 73-7181) mg/l. A median of two organs involved at baseline (range 1-3): 4 had cardiac involvement (half Mayo stage 2;half Mayo stage 3a) and 8 had renal involvement. The median prior lines of therapy was 3 (range 2-5) with all exposed to prior immunomodulatory drugs, proteasome inhibitors and 73% to anti-CD38 antibody treatments. Thirty-six percent had relapsed after melphalan-conditioned autologous stem cell transplantation. A median of 3 cycles of belantamab were delivered (range 1-8). The most frequent adverse event was ocular toxicity which was experienced in 8 patients (grade 1-3), necessitating dose modification of the three-weekly schedule. One patient developed transient grade 1 dyspnoea and liver dysfunction. No patients developed cytopenias, unlike previous reports (Zhang et al , 2021), nor infections beyond COVID (2 patients mild with no hospital admissions). The majority of the cohort required dose reduction either at initiation (patient 4, due to end stage renal failure;patient 11, post-renal transplant) or during therapy (n=5;three to 1.9mg/kg, two to 1.25mg/kg) due to ocular toxicity. Only one patient remained on the standard dose of 2.5mg/kg for >3 cycles. Ocular toxicity improved after treatment interruption (drug intervals 4-6 weeks) and no patients required complete treatment cessation. One patient is too early to assess response. Haematological responses (PR or better) were seen in 7 patients with 3 complete responses and two very good partial responses (VGPR) which are ongoing. Both renal patients (patients 4 and 11) commenced a dose of 1.25mg/kg and sustained a VGPR with no additional toxicity. Patient 3 had a 42% reduction in sFLC after two doses but then a prolonged gap due to keratopathy and has lost the response. There were no cardiac or renal toxicities observed. Summary/Conclusion: Belantamab mafodotin demonstrates significant activity in patients with heavily pre-treated AL amyloidosis with 70% achieving a ≥PR. Apart from keratopathy requiring dose modification, no other substantial toxicity was observed. Two patients with renal impairment (stage V CKD and ESRD) and one patient post-renal transplant tolerated treatment with no additional toxicity. Belantamab mafodotin shows promise in treatment of relapsed AL and needs further prospective trials.
ABSTRACT
Content: Introduction: Myeloma patients who have completed chemotherapy moved from an intensive period of interaction with healthcare professionals, to less frequent visits. At this time, they often struggle with disease burden, treatment side effects and age-related co-morbidities. Improved patient survival with novel therapies has resulted in increasing patient numbers in outpatient haematology clinics. Centralisation of services means that many patients travel long distances to maintain contact with their transplant centres because they value the access to new drugs and clinical trials, and expertise in management of transplant-related complications and relapse. Faced with growing numbers of patients in follow up with survivorship needs, a new patient-centred model of care is needed. Method: The Promoting Individualised Self-Management and Survivorship (PrISMS) clinic was designed for myeloma patients who are off treatment and in plateau phase. This remote clinic is staffed by a doctor, a nurse specialist and a physiotherapist, a multidisciplinary team (MDT) approach to holistic management centred on patient needs and providing consistent individualised physical activity and lifestyle advice. Two weeks before the consultation, patients complete a questionnaire about their concerns, symptoms and ways in which they would like to improve their health. This allows the MDT to prepare appropriate advice for each patient, ensuring efficient use of consultations. Patients are also required to have a blood test either locally or at University College London Hospital before the clinic. Results: From March 2019 to October 2020, 54 patients were enrolled into the pilot PrISMS clinic and 197 telephone or video consultations were held. The median call duration was 12 minutes. Most patients had their blood tests (89%) and questionnaires (84%) completed before the appointment. Patients needing closer monitoring or active treatment due to disease relapse (9/54) were referred immediately back to face-to-face clinics. 78% and 89% of patients received nurse specialist's and physiotherapist's advice respectively at any point in time, with 11 patients (20%) referred to local exercise programmes. Patients were signposted to survivorship tools such as online exercise videos and lifestyle mobile applications when appropriate. Patient feedback was positive, with 31 of the 36 surveyed patients (86%) agreed or strongly agreed that they felt more confident in self-managing myeloma after PrISMS consultations. 94% (34/36) agreed or strongly agreed that their concerns and symptoms were addressed, and 77% (28/36) gave an overall service rating of good or excellent. Thematic analysis of telephone feedback interviews with 22 participants revealed additional benefits of reduction in travel costs and time, substantially shorter clinic waiting times and reduction in associated psychological stress (Table 1). Conclusion: This new patient-centred model of care has been demonstrated to be safe and feasible, with good patient satisfaction. We hope that this MDT approach will empower patients, improve their clinical experience, and build trust in their clinical teams, as well as reducing patients' sense of isolation and vulnerability particularly in this time of COVID-19 crisis. Future work is needed to formally confirm its effects on patient reported outcome measures, safety and healthcare resource usage.
ABSTRACT
Myeloma patients who have completed chemotherapy move from an intensive period of interaction with healthcare professionals, to less frequent visits. At this time, they often struggle with disease burden, as well as treatment related toxicities and age-related co-morbidities. We previously reported from focus group interviews that patients need lifestyle support and advice to return to their pre-morbid social, psychological and economic functionality. Improved patient survival with novel therapies has resulted in increasing patient numbers in outpatient clinics. Centralisation of services means that many patients travel long distances to maintain contact with their transplant centre because they value the access to optimal treatment and clinical trials. Faced with growing numbers of patients in follow up with survivorship needs, we designed the Promoting Individualised Self- Management and Survivorship (PrISMS) clinic for myeloma patients who are off treatment and in plateau phase in early 2019. This remote clinic is staffed by a doctor, a nurse specialist and a physiotherapist, a multidisciplinary team approach to holistic management centred on patient needs and providing consistent individualised physical activity and lifestyle advice. Two weeks before the consultation, patients are required to have a blood test locally or at our hospital, and to complete a questionnaire about their concerns, symptoms and ways in which they would like to improve their health. We did not know at the time that such model of care would become especially pertinent as a result of the COVID-19 pandemic. From March 2019 to October 2020, we enrolled 54 patients into the pilot PrISMS clinic and held 197 telephone or video consultations. The median call duration was 12 minutes, with most patients having had their blood tests (89%) and questionnaires (84%) completed before the appointment. Patients needing closer monitoring or active treatment due to disease relapse (9/54) were referred immediately back to face-to-face clinics. 78% and 89% of patients received nurse specialist's and physiotherapist's advice at any point in time, with 11 patients (20%) referred to local exercise programmes. Regarding patients' feedback, 31 of the 36 surveyed patients (86%) agreed or strongly agreed that they felt more confident in self-managing myeloma after the consultations. 94% (34/36) of the survey patients agreed or strongly agreed that their concerns and symptoms were addressed, and 77% (28/36) gave an overall service rating of good or excellent. Thematic analysis of telephone interviews with 22 participants revealed additional benefits of reduction in travel costs and time, shorter waiting times and reduction in associated psychological stress (Table 1). PrISMS clinic aims to empower patients through patient-centred care by providing tailored advice, through enhancing patients' competences by signposting them to various survivorship tools (Table 2), and through active patient participation by setting achievable goals. We hope that this new care model will improve patients' clinical experience and build trust in their clinical teams particularly at this time of crisis, and to reduce their sense of isolation. We continue to evaluate this service based on patients' feedback to optimise individualised care and resource allocation. Future work is needed to formally confirm its effects on patient reported outcome measures, safety and healthcare resource usage. (Table Presented).