Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
Status:
Completed
Trial end date:
2016-07-14
Target enrollment:
Participant gender:
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.