Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Bortezomib will be administered on days: -6, -3, +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Complete Response rates (according to IMWG 2011 criteria)
Time frame: 60 days post Autologous Stem Cells Transplantation
overall survival
Time frame: 60 months
Response rates (according to IMWG 2011 criteria)
Compare response rate after ASCT and after the completion of consolidation therapy
Time frame: post ASCT and consolidation therapy
Serious adverse event
Time frame: End of study
progression-free survival between the two arms
Time frame: 60 months
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Clinique Universitaire Saint Luc
Brussels, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Belgium
Chu Liege
Liège, Belgium
CHU Dinant-Godinne UCL Namur
Yvoir, Belgium
Hôpital Felix Guyon
Saint-Denis, ILE de LA Reunion, France
CH sud Réunion
Saint-Pierre, ILE de LA Reunion, France
CHU Amiens
Amiens, France
Chu Angers
Angers, France
CH Argenteuil Victor Dupouy
Argenteuil, France
CH Bayonne
Bayonne, France
...and 36 more locations