Medicines

News in Brief: AL amyloidosis trials due this year; New blood product labelling standard cuts supply time by 75%; Extra COVID-19 surveillance in HSCT patients needed


AL amyloidosis trials due this year

Two trials are set to investigate new treatment regimens for newly diagnosed patients with AL amyloidosis with moderate to severe cardiac disease.

Both Phase III trials will look at standard therapy for AL – VCD (Velcade®, cyclophosphamide and dexamethasone) — plus either birtamimab  or CAEL-101, which are monoclonal antibodies that target the amyloid deposits and which investigators hope will clear the amyloid from affected organs.

Dr Simon Gibbs, Director of the Victorian and Tasmanian Amyloidosis Service said up to a quarter of patients still die within six months of diagnosis.

“Not everyone responds as well as we’d like to our standard upfront therapy, VCD Daratumumab is clearly an effective therapy to rescue patients who have poor responses to VCD, and the ANDROMEDA study proved that using daratumumab with VCD improves response rates. But we really need more rapidly effective treatments for patients presenting with advanced cardiac disease, or who don’t respond well enough to VCD.”

He said the two upcoming trials, AFFIRM-AL (birtamimab) and the CAEL-101 study, could help to “overcome early mortality and may offer advances in patient quality of life and survival”.

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‘Game-changer’: new blood labelling standard saves time, safer

Launceston General Hospital in Tasmania has become the first in Australia to adopt a new blood labelling standard that integrates with the National Blood Authority’s BloodNet system, cutting the time it takes to receipt blood products by 75%.

The integrated system, which also incorporates the new global ISBT128 standard, makes receipting blood products a ‘one-system’ task by removing the need for double-handling data entry into both the National Blood Authority system and hospital laboratory systems.

Michael Morse, scientist in charge of haematology at Northern Star Pathology told The Examiner the new interface is a ‘massive time saver’ and benefits patients.

“This is essentially a 75% saving in time in receipting blood products over our old laborious system and the chance of errors or issues is significantly reduced.”

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Extra COVID-19 surveillance for  HSCT patients needed

Stringent  COVID-19 surveillance and pre-emptive measures are needed for all haematopoietic stem-cell transplantation (HSCT) recipients, warn researchers after a large study shows patients have considerably higher risk of death from COVID-19 – including those patients more than a year from transplantation and no longer receiving immunosuppression.

The observational study – the largest series to date summarising clinical characteristics and outcomes of HSCT recipients with COVID-19 – reports on data collected from the Center for International Blood and Marrow Transplant Research (CIBMTR)  on more than 300 patients and separated for allogeneic and autologous HSCT.

The estimated 30-day overall survival after COVID-19 diagnosis was poor, at 68% (95% CI 58–77) for allogeneic HSCT recipients. Although older age has previously been shown to be associated with worse outcomes, the age cutoff was even lower for HSCT recipients, probably representing the additional burden of toxicity among HSCT survivors, the investigators said.

Age 50 years or older (hazard ratio 2·53, 95% CI 1·16–5·52; p=0·020); male sex (3·53; 1·44–8·67; p=0·006), and development of COVID-19 within 12 months of transplantation (2·67, 1·33–5·36; p=0·005) were associated with a higher risk of mortality among allogeneic HSCT recipients.

Meanwhile, having lymphoma was associated with a higher risk of mortality compared with plasma cell disorder or myeloma (2·41, [1·08–5·38]; p=0·033) in autologous HSCT recipients.

Researchers also found an almost four-times increased risk of death among male recipients of allogeneic HSCT.

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