Myeloma IX Trial

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This randomised controlled trial aims to evaluate whether thalidomide, together with induction therapy prolongs remission and overall survival, whether thalidomide in the maintenance setting prolongs remission and overall survival, whether the oral Z-Dex regimen is as effective an induction regimen as i.v. VAD with respect to survival and QOL, in younger/fitter patients, whether Z-Dex-C-weekly is as effective an induction/consolidation treatment as ?standard? chemotherapy (MP) with respect to survival and QOL, in older/less fit patients, and whether a second generation bisphosphonate (zoledronate) is superior to clodronate in inhibiting the bone changes in myeloma. In addition, the trial aims to assess whether the bisphosphonate exerts an antitumour effect in vivo, which translates into a survival benefit. 1600 patients will be randomised. The trial will comprise two groups of patients: younger/fitter and older/less fit. With the exception of the analysis of induction chemotherapy, the two groups will be combined for the primary comparisons. The primary end-points are remission rate, progression-free survival, relapse, survival. The secondary outcomes are quality of life and resource use. Protein studies, to include measurement of paraprotein (with immunofixation, as appropriate), and free light chains as objective measures of response, will be carried out centrally. Peripheral blood and bone marrow samples will be analysed centrally at presentation and at key specified time points, with in-depth assessment of responses using flow cytometry and PCR techniques. Patients will be followed up for five years, and then annually to death.