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Phase III pomalidomide trial reaches primary endpoint

Celgene has announced that its Phase III trial, OPTIMISMM, has achieved its primary endpoint of improving progression-free survival (PFS) in patients with relapsed or refractory myeloma. The study compared pomalidomide (Imnovid®) in combination with bortezomib (Velcade®) and low-dose dexamethasone to bortezomib and low-dose dexamethasone in myeloma patients who had received 1 – 3 prior treatments,…

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Carfilzomib combinations demonstrate overall survival benefit in relapsed and refractory myeloma

Results from the Phase III ASPIRE trial show that carfilzomib (Kyprolis®) in combination with lenalidomide (Revlimid®) and dexamethasone has a significant overall survival (OS) benefit in relapsed and refractory myeloma patients. Recently published in the Journal of Clinical Oncology, the results demonstrate that patients receiving carfilzomib, lenalidomide and dexamethasone had a median OS of 48.3…

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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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