Randomised comparisons in myeloma patients of all ages of thalidomide lenalidomide carfilzomib and bortezomib induction combinations and of lenalidomide and combination lenalidomide vorinostat as maintenance
The last ten years has seen the introduction of a number of effective new anti-myelomaagents into the clinical arena. These agents have been shown to be highly effective in therelapse setting and now are being introduced as treatment earlier in the disease course.This study therefore aims to address in the randomised setting some of the key questionsconcerning the use of thalidomide bortezomib and lenalidomide in the initial treatment ofmultiple myeloma patients. Newly diagnosed patients of all ages with symptomaticmyeloma requiring treatment are eligible.For initial treatment thalidomide in combination with cyclophosphamide anddexamethasone the UK gold standard will be compared with the newer combination oflenalidomide cyclophosphamide and dexamethasone. For patients with a sub-optimalresponse to initial therapy the response to the proteasome inhibitor bortezomib will beassessed as previous studies have demonstrated that it is able to induce responses andimprove progression-free and overall survival in patients resistant to standardchemotherapy. Patients young and fit enough to tolerate an autologous transplant willthen proceed to high dose melphalan with peripheral blood stem cell rescue. The value oflenalidomide maintenance will then be assessed by randomising eligible patients toreceive either lenalidomide maintenance therapy or close observation. The primary endpoints of the study are overall and progression-free survival (OS and PFS). Secondaryend points include response and toxicity. A number of laboratory based studies will alsobe performed in order to determine patient specific factors predicting overall andprogression-free survival and response to treatment.The study has undergone peer review and is supported by the NCRN and CTAAC.
|PI Name||Cook - MA|
|Sponsor||University of Leeds|
|Proposed End Date||31/05/2016|
|Study Run through CRF?||No|
|Target number of patients agreed to recruit||60|
|Recruitment so far||13|