Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years
Inclusion Criteria:
At time of diagnosis
- De novo multiple myeloma patients under 65 or in first relapse, in whom screening for
chromosome 13 deletion and beta2microglobulin assay have been performed.
- Salmon and Durie Stage: III, II, I with symptomatic bone lesion (radiological)
- Patient's written informed consent
- No clinical signs of heart failure or coronary insufficiency with LVEF>50%
- No hepatic in insufficiency: bilirubin<35μmol/l and SGOT, SGPT, alkaline phosphatase
less than 2.5 N
- No respiratory insufficiency: normal pulmonary function tests and DLCO>50%
- No pre-existing renal impairment not related to the disease
- No history of any other malignant disease with the exception of basal cell carcinoma
and stage I cervical cancer
- Negative HIV serology
- Effective contraception when justified
At the time of transplantation
- Good performance status (WHO score≤2)
- Creatinine≤170μmol/l and no ineligibility criteria for intensification
- Stem cells harvest ≥ 5x10E6 CD34/kg for 2 ASCT
- Absence of progressive disease before transplantation
Exclusion Criteria:
- Known refusal of the subject to participate to the study
- Female subject who is pregnant or breast-feeding
- History of allergy to any of the study medications, their analogues, or excipients in
the various formulations
- Main liver insufficiency
- ≥ Grade 3 peripheral neuropathy on clinical examination within 14 days before
enrollment