Myeloma IX Trial

Lead Research Organisation: University of Leeds
Department Name: School of Medicine


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Technical Summary

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.


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Boyd KD (2011) Gender disparities in the tumor genetics and clinical outcome of multiple myeloma. in Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology

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Dickens NJ (2010) Homozygous deletion mapping in myeloma samples identifies genes and an expression signature relevant to pathogenesis and outcome. in Clinical cancer research : an official journal of the American Association for Cancer Research

Description Submitted data to NICE appraisal of thalidomide use in myeloma
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
Impact Thalidomide in combination with an alkylating agent and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma in people for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate
Title Myeloma IX 
Description 1. Therapeutic questions within the intensive pathway: 1. 1. To compare an oral induction regimen containing thalidomide with a standard infusional induction chemotherapy, CTD versus CVAD, with respect to overall/progression-free survival and response. 1.2. To investigate the effects of giving additional consolidation therapy in the form of a low intensity conditioning allogeneic stem cell transplantation on survival. 2. Therapeutic questions within the non-intensive pathway: 2.1. To compare attenuated C-Thal-Dex (CTDa) with standard MP with respect to overall/progression-free survival and response. 3. Therapeutic questions across both pathways: 3.1. To assess the value of low dose thalidomide in maintenance in improving overall and progression-free survival. 3.2. To compare an aminobisphosphonate, zoledronic acid, with standard clodronate on the severity of bone disease and in improving survival. 3.3. To investigate quality of life in the short-term (during induction chemotherapy/bisphosphonate treatment) and in the long-term (during maintenance therapy). 3.4. To investigate prognostic factors for outcome. 4. Biological objectives: 4.1. To determine the clinical relevance of genetic/cytogenetic changes present at presentation in the definition of prognostic groups. 4.2. To determine the relevance of cellular phenotypes at presentation and to subsequently use these data to monitor residual disease. 4.3. To evaluate serum free light chain (flc) measurement as a prognostic factor and in monitoring disease. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2010
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Changed clinical practice, informed national guidelines, incorporated onto successor trial.