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Captisol-enabled™ melphalan meets primary endpoints in pivotal trial

The US biotechnology company, Spectrum Pharmaceuticals, has announced that its captisol-enabled (propylene glycol-free) melphalan has met the primary endpoints in a pivotal multi-centre Phase II trial. The trial, determining the safety and efficacy of captisol-enabled melphalan as a conditioning treatment prior to autologous stem cell transplantation in myeloma patients, found that the new formulation of…

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NICE issue draft ‘no’ for Revlimid® at first relapse

NICE has published new draft guidance on the use of Revlimid for relapsed myeloma patients after one prior treatment with Velcade, and who are intolerant to thalidomide and ineligible for high-dose therapy and stem cell transplantation. The guidance does not recommend Revlimid on the basis of insufficient data submitted to demonstrate that Revlimid is more…

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New investigational drug for myeloma placed on clinical hold

The FDA has issued verbal notice to the US biopharmaceutical company, Geron, warning that its investigational new drug application for imetelstat, a first-in-class telomerase inhibitor, has been placed on full clinical hold. This means that all ongoing clinical trials of imetelstat, including a Phase II trial for relapsed myeloma patients, are suspended until further notice.…

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Velcade® induction recommended for myeloma patients in England and Wales

The National Institute for Health and Care Excellence (NICE) has recommended the use of Velcade in combination with dexamethasone, or with dexamethasone and thalidomide, as induction treatment for newly diagnosed myeloma patients prior to high-dose therapy and stem cell transplantation. The recommendation is welcome news following an initial negative appraisal consultation document released in November…

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Mechanism of action of dinaciclib reveals potential synergistic activity with certain anti-myeloma treatments

Researchers at Virginia Commonwealth University Massey Cancer Centre, USA, have identified the mechanism responsible for the anti-tumour activity of the cyclin-dependent kinase inhibitor dinaciclib and suggest that it could improve the effectiveness of certain anti-myeloma treatments. The results of the preclinical study, published in Molecular Cancer Therapeutics, showed that dinaciclib disrupted the unfolded protein response…

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