Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone|
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: melphalan-prednisone-thalidomide||Drug: melphalan-prednisone-thalidomide|
|Active Comparator: lenalidomide-dexamethasone||Drug: lenalidomide-dexamethasone|
|CH Côte basque|
|Chalons sur Saone|
|Chalons sur Saone, France|
|La Roche Sur Yon, France|
|Centre Antoine LACASSAGNE|
|CH Yves Le Foll|
|St Brieuc, France|
|St CLOUD, France|
|Study Chair:||Philippe MOREAU, Pr||Departement of clinical Hematology (University Hospital of Nantes)|