Spots Global Cancer Trial Database for Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
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Trial Identification
Brief Title: Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
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 ID: NCT00907452
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CH ALBI, Albi, , France
CHRU Angers, Angers, , France
CH Côte basque, Bayonne, , France
CH Blois, Blois, , France
BORDEAUX, Bordeaux, , France
Chalon sur Saone, Chalon-sur-Saône, , France
CHU Dijon, Dijon, , France
Ch Dunkerque, Dunkerque, , France
Chu Grenoble, Grenoble, , France
CHD Vendée, La Roche Sur Yon, , France
CHRU Lille, Lille, , France
CHU LYON, Lyon, , France
LYON SUD, Lyon, , France
Ipc Marseille, Marseille, , France
CHR METZ, Metz, , France
CH Mulhouse, Mulhouse, , France
Chu Nancy, Nancy, , France
Chu Nantes, Nantes, , France
Centre Antoine LACASSAGNE, Nice, , France
Institut Curie, Paris, , France
Chu Poitiers, Poitiers, , France
Chu Rennes, Rennes, , France
CH Yves Le Foll, St Brieuc, , France
René Huguenin, St CLOUD, , France
Chu Toulouse, Toulouse, , France
Chu Tours, Tours, , France
Contact Details
Name: Philippe MOREAU, Pr
Affiliation: Departement of clinical Hematology (University Hospital of Nantes)
Role: STUDY_CHAIR
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