Medicine (St Vincent's) - Research Publications

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    Australia and New Zealand consensus position statement: use of COVID-19 therapeutics in patients with haematological malignancies
    Campbell, A ; Teh, B ; Mulligan, S ; Ross, DM ; Weinkove, R ; Gilroy, N ; Gangatharan, S ; Prince, HM ; Szer, J ; Trotman, J ; Lane, S ; Dickinson, M ; Quach, H ; Enjeti, AK ; Ku, M ; Gregory, G ; Hapgood, G ; Ho, PJ ; Cochrane, T ; Cheah, C ; Greenwood, M ; Latimer, M ; Berkahn, L ; Wight, J ; Armytage, T ; Diamond, P ; Tam, CS ; Hamad, N (Wiley, 2023-02)
    Despite widespread vaccination rates, we are living with high transmission rates of SARS-CoV-2. Although overall hospitalisation rates are falling, the risk of serious infection remains high for patients who are immunocompromised because of haematological malignancies. In light of the ongoing pandemic and the development of multiple agents for treatment, representatives from the Haematology Society of Australia and New Zealand and infectious diseases specialists have collaborated on this consensus position statement regarding COVID-19 management in patients with haematological disorders. It is our recommendation that both patients with haematological malignancies and treating specialists be educated regarding the preventive and treatment options available and that patients continue to receive adequate vaccinations, keeping in mind the suboptimal vaccine responses that occur in haematology patients, in particular, those with B-cell malignancies and on B-cell-targeting or depleting therapy. Patients with haematological malignancies should receive treatment for COVID-19 in accordance with the severity of their symptoms, but even mild infections should prompt early treatment with antiviral agents. The issue of de-isolation following COVID-19 infection and optimal time to treatment for haematological malignancies is discussed but remains an area with evolving data. This position statement is to be used in conjunction with advice from infectious disease, respiratory and intensive care specialists, and current guidelines from the National COVID-19 Clinical Evidence Taskforce and the New Zealand Ministry of Health and Cancer Agency Te Aho o Te Kahu COVID-19 Guidelines.
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    The second revision of the International Staging System (R2-ISS) stratifies progression-free and overall survival in multiple myeloma: Real world data results in an Australian and New Zealand Population
    Tan, JLC ; Wellard, C ; Moore, EM ; Mollee, P ; Rajagopal, R ; Quach, H ; Harrison, SJ ; McDonald, E-J ; Ho, PJ ; Prince, HM ; Augustson, BM ; Campbell, P ; McQuilten, ZK ; Wood, EM ; Spencer, A (WILEY, 2023-01)
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    Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results
    Lesokhin, AH ; Tomasson, M ; Arnulf, BJ ; Bahlis, N ; Prince, HM ; Niesvizky, R ; Rodriguez-Otero, P ; Martinez-Lopez, J ; Koehne, G ; Touzeau, C ; Jethava, Y ; Quach, H ; Depaus, J ; Yokoyama, H ; Gabayan, AEA ; Stevens, DK ; Nooka, A ; Manier, S ; Raje, N ; Iida, S ; Raab, M-S ; Searle, E ; Leip, ET ; Sullivan, S ; Conte, U ; Elmeliegy, M ; Czibere, A ; Viqueira, A ; Mohty, M (Nature Research, 2023)
    Elranatamab is a humanized B-cell maturation antigen (BCMA)-CD3 bispecific antibody. In the ongoing phase 2 MagnetisMM-3 trial, patients with relapsed or refractory multiple myeloma received subcutaneous elranatamab once weekly after two step-up priming doses. After six cycles, persistent responders switched to biweekly dosing. Results from cohort A, which enrolled patients without prior BCMA-directed therapy (n = 123) are reported. The primary endpoint of confirmed objective response rate (ORR) by blinded independent central review was met with an ORR of 61.0% (75/123); 35.0% ≥complete response. Fifty responders switched to biweekly dosing, and 40 (80.0%) improved or maintained their response for ≥6 months. With a median follow-up of 14.7 months, median duration of response, progression-free survival and overall survival (secondary endpoints) have not been reached. Fifteen-month rates were 71.5%, 50.9% and 56.7%, respectively. Common adverse events (any grade; grade 3-4) included infections (69.9%, 39.8%), cytokine release syndrome (57.7%, 0%), anemia (48.8%, 37.4%), and neutropenia (48.8%, 48.8%). With biweekly dosing, grade 3-4 adverse events decreased from 58.6% to 46.6%. Elranatamab induced deep and durable responses with a manageable safety profile. Switching to biweekly dosing may improve long-term safety without compromising efficacy. ClinicalTrials.gov identifier: NCT04649359 .
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    The importance of frailty assessment in multiple myeloma: a position statement from the Myeloma Scientific Advisory Group to Myeloma Australia
    Sim, S ; Kalff, A ; Tuch, G ; Mollee, P ; Ho, PJ ; Harrison, S ; Gibbs, S ; Prince, HM ; Spencer, A ; Joshua, D ; Lee, C ; Ling, S ; Murphy, N ; Szabo, F ; Szer, J ; Weber, N ; Ward, C ; Talaulikar, D ; Zannettino, A ; Quach, H (WILEY, 2023-05)
    Multiple myeloma (MM) is a disease of older people, yet factors relating to comorbidity and frailty may threaten treatment tolerability for many of this heterogenous group. There has been increasing interest in defining specific and clinically relevant frailty assessment tools within the MM population, with the goal of using these frailty scores, not just as a prognostic instrument, but also as a predictive tool to allow for a frailty-adapted treatment approach. This paper reviews the various frailty assessment frameworks used in the evaluation of patients with MM, including the International Myeloma Working Group Frailty Index (IMWG-FI), the Mayo Frailty Index and the simplified frailty scale. While the IMWG-FI remains the most widely accepted tool, the simplified frailty scale is the most user-friendly in busy day-to-day clinics based on its ease of use. This paper summarises the recommendations from the Myeloma Scientific Advisory Group (MSAG) of Myeloma Australia, on the use of frailty assessment tools in clinical practice and proposes a frailty-stratified treatment algorithm to aid clinicians in tailoring therapy for this highly heterogeneous patient population.
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    ASTCT Clinical Practice Recommendations for Transplantation and Cellular Therapies in Multiple Myeloma
    Dhakal, B ; Shah, N ; Kansagra, A ; Kumar, A ; Lonial, S ; Garfall, A ; Cowan, A ; Poudyal, BS ; Costello, C ; Gay, F ; Cook, G ; Quach, H ; Einsele, H ; Schriber, J ; Hou, J ; Costa, L ; Aljurf, M ; Chaudhry, M ; Beksac, M ; Prince, M ; Mohty, M ; Janakiram, M ; Callander, N ; Biran, N ; Malhotra, P ; Otero, PR ; Moreau, P ; Abonour, R ; Iftikhar, R ; Silberman, R ; Mailankody, S ; Gregory, T ; Lin, Y ; Carpenter, P ; Hamadani, M ; Usmani, S ; Kumar, S (ELSEVIER SCIENCE INC, 2022-06)
    Over the past decade, therapeutic options in multiple myeloma (MM) have changed dramatically. Given the unprecedented efficacy of novel agents, the role of hematopoietic cell transplantation (HCT) in MM remains under scrutiny. Rapid advances in myeloma immunotherapy including the recent approval of chimeric antigen receptor (CAR) T-cell therapy will impact the MM therapeutic landscape. The American Society for Transplantation and Cellular Therapy convened an expert panel to formulate clinical practice recommendations for role, timing, and sequencing of autologous (auto-HCT), allogeneic (allo-HCT) and CAR T-cell therapy for patients with newly diagnosed (NDMM) and relapsed/refractory MM (RRMM). The RAND-modified Delphi method was used to generate consensus statements. Twenty consensus statements were generated. The panel endorsed continued use of auto-HCT consolidation for patients with NDMM as a standard-of-care option, whereas in the front line allo-HCT and CAR-T were not recommended outside the setting of clinical trial. For patients not undergoing auto-HCT upfront, the panel recommended its use in first relapse. Lenalidomide as a single agent was recommended for maintenance especially for standard risk patients. In the RRMM setting, the panel recommended the use of CAR-T in patients with 4 or more prior lines of therapy. The panel encouraged allo-HCT in RRMM setting only in the context of clinical trial. The panel found RAND-modified Delphi methodology effective in providing a formal framework for developing consensus recommendations for the timing and sequence of cellular therapies for MM.
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    Bisphosphonate guidelines for treatment and prevention of myeloma bone disease
    Lee, OL ; Horvath, N ; Lee, C ; Joshua, D ; Ho, J ; Szer, J ; Quach, H ; Spencer, A ; Harrison, S ; Mollee, P ; Roberts, AW ; Talaulikar, D ; Brown, R ; Augustson, B ; Ling, S ; Jaksic, W ; Gibson, J ; Kalff, A ; Johnston, A ; Kalro, A ; Ward, C ; Prince, HM ; Zannettino, A (WILEY, 2017-08)
    Multiple myeloma (MM) is a haematological malignancy characterised by the clonal proliferation of plasma cells in the bone marrow. More than 80% of patients with MM display evidence of myeloma bone disease (MBD), characterised by the formation of osteolytic lesions throughout the axial and appendicular skeleton. MBD significantly increases the risk of skeletal-related events such as pathologic fracture, spinal cord compression and hypercalcaemia. MBD is the result of MM plasma cells-mediated activation of osteoclast activity and suppression of osteoblast activity. Bisphosphonates (BP), pyrophosphate analogues with high bone affinity, are the only pharmacological agents currently recommended for the treatment and prevention of MBD and remain the standard of care. Pamidronate and zoledronic acid are the most commonly used BP to treat MBD. Although generally safe, frequent high doses of BP are associated with adverse events such as renal toxicity and osteonecrosis of the jaw. As such, optimal duration and dosing of BP therapy is required in order to minimise BP-associated adverse events. The following guidelines provide currently available evidence for the adoption of a tailored approach when using BP for the management of MBD.
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    Upfront lower dose lenalidomide is less toxic and does not compromise efficacy for vulnerable patients with relapsed refractory multiple myeloma: final analysis of the phase II RevLite study
    Quach, H ; Fernyhough, L ; Henderson, R ; Corbett, G ; Baker, B ; Browett, P ; Blacklock, H ; Forsyth, C ; Underhill, C ; Cannell, P ; Trotman, J ; Neylon, A ; Harrison, S ; Link, E ; Swern, A ; Cowan, L ; Dimopoulos, MA ; Prince, HM (WILEY, 2017-05)
    The combination of lenalidomide and dexamethasone is an established treatment for patients with multiple myeloma (MM). Increasingly, treatment attenuation is advocated for frail/elderly patients to minimize toxicity even though there have been no prospective studies to demonstrate whether lenalidomide dose attenuation impacts on response and survival outcome. This prospective multicentre phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15 mg) and dexamethasone (20 mg) in 149 eligible patients with relapsed/refractory MM aged over 59 years and/or with renal impairment. The overall response rate was 71% (complete response 15%). Median (range) progression-free survival (PFS) and overall survival (OS) were 8·9 (6·9-11·5) and 30·5 (20·0-36·2) months, respectively. Upon formal statistical comparison of these endpoints to that of a matched cohort of patients from the pivotal phase III MM009/MM010 studies who received standard-dose lenalidomide (25 mg) and high-dose dexamethasone (40 mg) no difference was seen in PFS (P = 0·34) and OS (P = 0·21). Importantly, grade 3-4 toxicities were reduced with low-dose lenalidomide, mainly lower neutropenia (29% vs. 41%), infections (23% vs. 31%) and venous thromboembolism (3% vs. 13%). This study supports a strategy of lenalidomide dose reduction at the outset for at-risk patients, and prospectively confirms that such an approach reduces adverse events while not compromising patient response or survival outcomes.
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    Treatment of patients with Waldenstrom macroglobulinaemia: clinical practice guidelines from the Myeloma Foundation of Australia Medical and Scientific Advisory Group
    Talaulikar, D ; Tam, CS ; Joshua, D ; Ho, JP ; Szer, J ; Quach, H ; Spencer, A ; Harrison, S ; Mollee, P ; Roberts, AW ; Horvath, N ; Lee, C ; Zannettino, A ; Brown, R ; Augustson, B ; Jaksic, W ; Gibson, J ; Kalff, A ; Johnston, A ; Trotman, J ; Kalro, A ; Grigoriadis, G ; Ward, C ; Prince, HM (WILEY, 2017-01)
    Waldenström macroglobulinaemia (WM) is an indolent B-cell malignancy characterised by the presence of immunoglobulin M (IgM) paraprotein and bone marrow infiltration by clonal small B lymphocytes, plasmacytoid lymphocytes and plasma cells. The symptoms of WM are protean, often follow an asymptomatic phase and may include complications related to the paraneoplastic effects of IgM paraprotein. The revised 2016 World Health Organization classification includes the MYD88 L265P mutation, which is seen in >90% of cases, within the diagnostic criteria for WM. While treatment of WM has often been considered together with other indolent B cell lymphomas, there are unique aspects of WM management that require specific care. These include the unreliability of IgM and paraprotein measurements in monitoring patients prior to and after treatment, the lack of correlation between disease burden and symptoms and rituximab-induced IgM flare. Moreover, while bendamustine and rituximab has recently been approved for reimbursed frontline use in WM in Australia, other regimens, including ibrutinib- and bortezomib-based treatments, are not funded, requiring tailoring of treatment to the regional regulatory environment. The Medical and Scientific Advisory Group of the Myeloma Foundation Australia has therefore developed clinical practice guidelines with specific recommendations for the work-up and therapy of WM to assist Australian clinicians in the management of this disease.
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    COVID-19 vaccination in haematology patients: an Australian and New Zealand consensus position statement
    McCaughan, G ; Di Ciaccio, P ; Ananda-Rajah, M ; Gilroy, N ; MacIntyre, R ; Teh, B ; Weinkove, R ; Curnow, J ; Szer, J ; Enjeti, AK ; Ross, DM ; Mulligan, S ; Trotman, J ; Dickinson, M ; Quach, H ; Choi, P ; Polizzotto, MN ; Tam, CS ; Ho, PJ ; Ku, M ; Gregory, G ; Gangatharan, S ; Hapgood, G ; Cochrane, T ; Cheah, C ; Gibbs, S ; Wei, A ; Johnston, A ; Greenwood, M ; Prince, HM ; Latimer, M ; Berkahn, L ; Wight, J ; Armytage, T ; Hamad, N (WILEY, 2021-05)
    Australia and New Zealand have achieved excellent community control of COVID-19 infection. In light of the imminent COVID-19 vaccination roll out in both countries, representatives from the Haematology Society of Australia and New Zealand and infectious diseases specialists have collaborated on this consensus position statement regarding COVID-19 vaccination in patients with haematological disorders. It is our recommendation that patients with haematological malignancies, and some benign haematological disorders, should have expedited access to high-efficacy COVID-19 vaccines, given that these patients are at high risk of morbidity and mortality from COVID-19 infection. Vaccination should not replace other public health measures in these patients, given that the effectiveness of COVID-19 vaccination, specifically in patients with haematological malignancies, is not known. Given the limited available data, prospective collection of safety and efficacy data of COVID-19 vaccination in this patient group is a priority.
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    Considerations for pre-transfusion immunohaematology testing in patients receiving the anti-CD38 monoclonal antibody daratumumab for the treatment of multiple myeloma
    Quach, H ; Benson, S ; Haysom, H ; Wilkes, A-M ; Zacher, N ; Cole-Sinclair, M ; Prince, HM ; Mollee, P ; Spencer, A ; Ho, PJ ; Harrison, SJ ; Lee, C ; Augustson, B ; Daly, J (WILEY, 2018-02)
    In recent years, the anti-CD38 monoclonal antibody daratumumab (Darzalex; Janssen-Cilag Pty Ltd) has been shown to be highly efficacious in relapsed and refractory multiple myeloma, with the final results of treatment in newly diagnosed patients awaited. Despite awareness of the potential interference of daratumumab in pre-transfusion immunohaematology testing during phase I and II clinical studies, there was a degree of unpreparedness in the community upon the introduction of this drug into the clinics, particularly the impact that it has on the operational processes in hospital transfusion laboratories and timely issue of red blood cells (RBCs). Anti-CD38 interference in pre-transfusion immunohaematology tests is a particular problem in patients being treated with daratumumab for multiple myeloma as many will require RBC transfusions during their disease treatment. Panagglutination caused by anti-CD38 monoclonal antibody during the indirect antiglobulin test may mask the presence of a clinically significant RBC alloantibody in the patient's plasma during the antibody screen and identification process, which may be overlooked, particularly in urgent situations, subsequently resulting in a delayed or acute haemolytic transfusion reaction. Here, we summarise daratumumab's effects on pre-transfusion immunohaematology testing and its impact on clinical practice and make practical recommendations based on a consensus from medical and scientific transfusion experts and myeloma specialists on behalf of the Australian and New Zealand Society of Blood Transfusion and Myeloma Scientific Advisory Group to Myeloma Australia, respectively.