Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma

Inclusion criteria

• Must have results from their initial diagnosis available at the time of screening to confirm all the following :

• Diagnosis of multiple myeloma according to the diagnostic
• Symptomatic de novo Multiple Myeloma
• Be eligible for high-dose therapy with autologous stem cell transplantation
• Autologous cell graft with a total number of CD 34 cells > or = 5 X 106/kg before freezing

Exclusion criteria

• Progressive disease
• Females participants pregnant or breast-feeding
• A known infection by the human immunodeficiency virus
• An active viral hepatitis B or C
• Unstable angina or myocardial infarction within 4 months prior to inclusion, heart failure NYHA class III or IV angina, uncontrolled, history of severe coronary artery disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or electrocardiographic evidence of acute ischemia or conduction disturbances grade 3 unless the patient has a pacemaker
• Uncontrolled hypertension or uncontrolled diabetes within 14 days before enrollment
• A history of another malignancy. If cancer was diagnosed more than 10 years and considered as cured, an authorization may be requested on a case-by-case basis after discussion with the principal investigator
• A significant neuropathy of grade 3-4 or grade 2 with pain in the 14 days prior to enrollment