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

NCT00907452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2021-04-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

melphalan-prednisone-thalidomide

DRUG

lenalidomide-dexamethasone

Sponsors & Collaborators

  • Intergroupe Francophone du Myelome

    lead NETWORK

Principal Investigators

  • Philippe MOREAU, Pr · Departement of clinical Hematology (University Hospital of Nantes)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00907452 on ClinicalTrials.gov