This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma. Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.
The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma. in each treatment arm there will be : 1. Induction therapy : 4 cycles of VTD (21 days)or VCD 2. Systematic stem cell harvest after cycle 3
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
358
Centre Hospitalier de la région d'Annecy
Annecy, Pringy, France
CHRU Hôpital Sud
Amiens, France
CHU Angers
Angers, France
Centre Hospitalier Argenteuil
Argenteuil, France
Centre Hospitalier H.Duffaut
Avignon, France
Centre Hospitalier de la Côte Basque
Response assessment according to the criteria IMWG
compare the Response assessment in both arms: the Very good partial remission rate (according to the criteria IMWG) achieved with four courses of VTD with that achieved with four courses of VCD
Time frame: 15-17 month
Response assessment according to the criteria IMWG
compare the Response assessment in both arms: the following parameters after induction treatment with four courses of VTD or four courses of VCD the Complete remission rate (according to the criteria IMWG)
Time frame: 15 - 17 month
Number of Adverse Events
To evaluate the Safety of induction therapy
Time frame: 15-17 month
Number of collected stem cell
Time frame: 17 month
Number of death
To evaluate Overall and Progression-Free Survival
Time frame: 17 month
Response assessment according to the criteria IMWG
compare the Response assessment in both arms: Compare the following parameters after induction treatment with four courses of VTD or four courses of VCD the Partial remission rate (according to the criteria IMWG)
Time frame: 15-17 month
Number of relapse according to the criteria IMWG
Progression-Free Survival
Time frame: 17 month
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Bayonne, France
CHRU de Besançon
Besançon, France
Hôpital Avicenne
Bobigny, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Centre hospitalier Pierre Oudot
Bourgoin, France
...and 52 more locations