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Results from TEAMM clinical trial reported

Results from the Phase III TEAMM (Tackling EArly Morbidity and Mortality in Myeloma) trial have recently been reported at the American Society of Haematology 2017 conference. This study assessed the benefit of levofloxacin antibiotic prophylaxis and its effect on healthcare associated infections in newly diagnosed myeloma patients. The results show that levofloxacin prophylaxis had a…

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FDA approves denosumab for myeloma patients

The U.S. Food and Drug Administration (FDA) has approved the use of denosumab (Xgeva®) for preventing skeletal related events (SRE) in myeloma patients. This decision is based on the results from a Phase III trial which compared denosumab to zoledronic acid (Zometa®). This study demonstrated that denosumab was not inferior to zoledronic acid in terms of…

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Carfilzomib treatment associated with cardiovascular events in myeloma patients

A meta-analysis conducted by researchers at the University of Pennsylvania has shown that treatment with carfilzomib (Kyprolis®) is associated with a higher incidence of cardiovascular events in myeloma patients. The study found that 18.1% of myeloma patients receiving carfilzomib experienced cardiovascular events, including hypertension, cardiac arrest, cardiac failure and arrhythmias, compared to only 3.8% of…

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Sanofi launches Phase III trials investigating isatuximab for myeloma patients

The French pharmaceutical company, Sanofi, has launched two new Phase III trials to investigate the impact of isatuximab on progression-free survival in newly diagnosed and relapsed or refractory myeloma patients. The IKEMA trial (NCT03275285) is comparing isatuximab in combination with carfilzomib (Kyprolis®) and dexamethasone, compared to carfilzomib and dexamethasone alone in relapsed or refractory myeloma…

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FDA removes clinical holds from several checkpoint inhibitor trials in myeloma

The U.S. Food and Drug Administration (FDA) has removed the partial clinical holds placed on several clinical trials investigating checkpoint inhibitors in combination with immunomodulatory drugs for myeloma patients. The Roche trial (NCT02431208) investigating atezolizumab (Tecentriq®) in combination with pomalidomide or lenalidomide for relapsed and refractory myeloma patients will now continue with protocol amendments as…

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Study demonstrates differences in mutation frequencies between African American and Caucasian myeloma patients

A study, recently published in PLoS Genetics, has demonstrated significant differences in mutation frequencies between African American (AA) and Caucasian (CA) patients with newly diagnosed myeloma. Researchers at the University of Southern California analysed data from the Multiple Myeloma Research Foundation’s CoMMpass study to determine genetic alterations in myeloma in the context of self-reported race.…

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Janssen submits application to EMA for the use of daratumumab in newly diagnosed myeloma patients

Janssen has submitted an application to the European Medicines Agency (EMA) to extend the marketing authorisation for daratumumab (Darzalex®) to include its use in combination with bortezomib (Velcade®), melphalan and prednisone as a treatment for newly diagnosed myeloma patients who are ineligible for an autologous stem cell transplant (ASCT). This decision is based on the…

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