Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)
- Registration Number
- NCT00642395
- Lead Sponsor
- University Hospital, Toulouse
- 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 response (VGPR= greater than 90% reduction of monoclonal component). However, only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of disease.
Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.
This study will be conducted in patients under the age of 65 with de novo multiple myeloma or in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion (radiological)and no contraindication to intensification. The primary objective will be to increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%, 61 patients will be included.
Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning regimen, the progression-free survival and the overall survival after intensification. Response rates will be evaluated according to the response criteria defined by. Analysis will be performed on an intention-to-treat basis.
After conventional induction therapy and PBSC collection, patients will be offered this new conditioning regimen. they will be free to refuse this regimen, in which case they will receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem cell transplantation.
Evaluation will occur at 3 months post intensification.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Bortezomib bortézomib
- Primary Outcome Measures
Name Time Method Evaluate the Complete Response and Very Good Partial Response (VGPR) rates 3 months after autologous blood stem cell transplantation conditioned by Velcade-Melphalan 3 months after autologous stem cell transplantation
- Secondary Outcome Measures
Name Time Method Assess the toxicity of this Velcade-Melphalan conditioning regimen (hematological and visceral toxicity-NCI criteria) - To assess the progression-free survival after transplantation - To assess the overall survival after tran 3 months
Trial Locations
- Locations (34)
Service of Hematology -Henri Becquerel Center
🇫🇷Rouen, France
Service of Blood Deseases - South Hospital
🇫🇷Amiens, France
Service of Clinical Hematology - F. Baclesse Center
🇫🇷Caen, France
Service of Clinical Hematology - UH of Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Service of Hematology - Bocage Hospital
🇫🇷Dijon, France
Service of Clinical Hematology - Army Instruction Hospital of Percy
🇫🇷Clamart, France
Service of Clinical Hematology - A. Morvan Hospital
🇫🇷Brest, France
Service of Clinical Hematology - Bocage Hospital
🇫🇷Angers, France
Service of Clinical Hematology - Cote Basque Hospital
🇫🇷Bayonne, France
Service of Clinical Hematology - Avicenne Hospital
🇫🇷Bobigny, France
Service of Hematology - General Hospital
🇫🇷Dunkerque, France
Service of Blood Deseases - UH of Nantes
🇫🇷Nantes, France
Service of Hematology - Léon Bérard Center
🇫🇷Lyon, France
Service of Hematology - Jean Bernard Hospital
🇫🇷Poitiers, France
Service of Hematology - R.Debré Hospital
🇫🇷Reims, France
Service of Hematology - Pontchaillou Hospital
🇫🇷Rennes, France
Service of Oncohematology - Louis Pasteur Hospital
🇫🇷Colmar, France
Service of Hematology - Claude Hurriez Hospital
🇫🇷Lille, France
Service of Clinical Hematology - Archet 1 Hospital
🇫🇷Nice, France
Service of Hematology - Edouard Herriot Hospital
🇫🇷Lyon, France
Service of Hematology - Lyon Sud Hospital
🇫🇷Lyon, France
Service of Hematology - Paoli Calmette Institute
🇫🇷Marseille, France
Service of Hematology - Notre Dame du Bon Secours Hospital
🇫🇷Metz, France
Service of Onco-Hematology - Bretonneau Hospital
🇫🇷Tours, France
Service of Blood Deseases - Saint Antoine Hospital
🇫🇷Paris, France
Service of Hematology - Hautepierre Hospital
🇫🇷Strasbourg, France
Service of Hematology -Gustave Roussy Institute
🇫🇷Villejuif, France
Service of Hematology - Cochin Hospital
🇫🇷Paris, France
Service of Oncology - Archet 1 Hospital
🇫🇷Nice, France
Service of Hematology - Hotel Dieu
🇫🇷Paris, France
Service of Clinical Hematology - Purpan hospital TSA 40031
🇫🇷Toulouse, France
Service of Hematology - Brabois Hospital
🇫🇷Vandoeuvre, France
Service of Clinical Hematology - Minjoz Hospital
🇫🇷Besançon, France
Service of Hematology - A. Michallon Hospital
🇫🇷Grenoble, France