Newly Diagnosed Myeloma Patient Above 65 Years Old
Conditions
Keywords
Multiple Myeloma, Autologous Stem Cell Transplantation, Elderly Patients
Brief summary
Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.
Detailed description
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* newly diagnosed MM, * age over 65, * measurable disease
Exclusion criteria
* Patients less than 65 and/or not proceeding to autologous PBSC transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Response | after induction, 3 months post transplant, 2 months post consolidation |
| Time To Progression | 2 years |
| Overall Survival | 2 years |
Countries
France
Outcome results
None listed