Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65
18 Years
N/A
Both
Newly Diagnosed Myeloma Patient Above 65 Years Old
Trial Information
Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65
Newly diagnosed myeloma patients above the age of 65 years will be treated the following
way: Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade
Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the
induction phase, for patients at least in partial remission, a collection of peripheral
blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140
mg/m2) followed by PBSC autologous transplantation is then performed. Three months post
transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are
allowed.
Inclusion Criteria:
- newly diagnosed MM,
- age over 65,
- measurable disease
Exclusion Criteria:
- Patients less than 65 and/or not proceeding to autologous PBSC transplantation
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Progression Free survival
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Laurent Garderet, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
LGT-2012
NCT ID:
NCT01671826
Start Date:
October 2012
Completion Date:
December 2016
Related Keywords:
- Newly Diagnosed Myeloma Patient Above 65 Years Old
- Multiple Myeloma
- Autologous Stem Cell Transplantation
- Elderly Patients
- Multiple Myeloma
- Neoplasms, Plasma Cell
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