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Myeloma XII opens for recruitment

The latest national myeloma trial, Myeloma XII, has recently opened for patient recruitment. The aim of this Phase III trial is to determine whether ixazomib (Ninlaro®) has a significant impact on the depth and duration of response when used as an augmented conditioning treatment in salvage autologous stem cell transplantation (ASCT) and then as post-transplant…

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FDA places partial clinical hold on all selinexor trials

The US Food and Drug Administration (FDA) has placed a partial hold on all clinical trials involving selinexor according to Karyopharm Therapeutics, the company developing the drug. Selinexor is the first in a new class of drugs known as Selective Inhibitor of Nuclear Export (SINE™) compounds which by inhibiting XPO-1 mediated nuclear-cytoplasmic protein transport, causes…

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NICE issues draft “no” on daratumumab monotherapy

The National Institute for Health and Care Excellence (NICE) has issued draft negative guidance for daratumumab (Darzalex®) monotherapy as a treatment for relapsed and refractory myeloma patients. Although daratumumab monotherapy was granted a licence by the European Medicines Agency (EMA) based on results of two Phase II trials, the degree of uncertainty for the clinical…

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Experimental drug stimulates the immune system against myeloma

A study, published recently in Nature Medicine, has demonstrated that the experimental drug LCL-161 causes robust anti-myeloma activity through stimulation of the immune system. LCL-161 is a small-molecule inhibitor of apoptosis (IAP) which was originally developed to promote tumour cell death via apoptosis. However, in this study robust anti-myeloma activity was observed via upregulation of…

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EMA recommends expanded daratumumab indication for myeloma

Genmab and Janssen have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation to expand the existing market licence for daratumumab (Darzalex®) as a treatment for relapsed and/or refractory myeloma patients. Currently licensed as a monotherapy, the latest recommendation is for the use of…

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Study shows no link between response rates and survival in myeloma

Results of a meta-regression analysis have shown that, contrary to popular opinion, there is no association between conventional response outcomes, such as complete response (CR) or very good partial response (VGPR), and survival in newly diagnosed myeloma patients. Published recently in the European Journal of Haematology, the researchers explored the relationship between response to initial…

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Phase I trial of Actimab-M starts for relapsed and/or refractory myeloma patients

The US biopharmaceutical company, Actinium Pharmaceuticals Inc., has announced it is starting a Phase I trial of its drug Actimab-M for relapsed and/or refractory myeloma patients. Actimab-M is the anti-CD33 antibody, HuM-195, conjugated to the radioactive compound actinium 225 and has been used in other haematological malignancies including acute myeloid leukaemia. Studies show that CD33…

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Sebia and Janssen join forces to develop IVD test for myeloma

Sebia, the French specialty diagnostics company, has announced that it is collaborating with Janssen Biotec Inc. to develop an in vitro diagnostic (IVD) test that mitigates the potential interference darartumumab (Darzalex®) can cause when visualising monoclonal proteins by immunofixation electrophoresis. Daratumumab, an anti-CD38 human monoclonal antibody currently being developed by Janssen as a treatment for…

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