Status:
COMPLETED
Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Intergroupe Francophone du Myelome
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Intensification with autologous stem cell (ASCT) is currently the most effective treatment for subjects under 65 and the essential goal is to achieve complete response (CR) or very good partial respon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00642395
Start Date
July 1 2007
End Date
July 1 2011
Last Update
May 12 2017
Active Locations (34)
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1
Service of Blood Deseases - South Hospital
Amiens, France, 80054
2
Service of Clinical Hematology - Bocage Hospital
Angers, France, 49033
3
Service of Clinical Hematology - Cote Basque Hospital
Bayonne, France, 64109
4
Service of Clinical Hematology - Minjoz Hospital
Besançon, France, 25030