drugset / Trial / NCT00907452

Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone

NCT00907452

Completed 143 enrolled Intergroupe Francophone du Myelome
RandomizedParallel-groupOpen-labelOther

Summary

This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma. To this end, the study seeks to predict the following parameters in these patients: * The treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination. * Progression-free survival and overall survival. Prediction of the treatment response and the occurrence of adverse effects will be based on: * An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and DNA copy number variations. * An analysis of changes in the tumor's genotype (change in the DNA copy number) and phenotype (altered gene and micro-RNA expression). Prediction of progression-free survival and overall survival will be based on an analysis of changes in the tumor's genotype and phenotype.

Timeline

Start
2009-07-29
Primary completion
2010-12-14
Completion
2016-07-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule
Comparator Lenalidomide Other / unclassified
Comparator Melphalan Small molecule
Comparator Prednisone Other / unclassified
Comparator Thalidomide Other / unclassified

Indications