Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)
1 other identifier
interventional
61
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Jul 2007
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 13, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMay 12, 2017
May 1, 2017
1.3 years
March 13, 2008
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALbortézomib
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- Intergroupe Francophone du Myelomecollaborator
Study Sites (34)
Service of Blood Deseases - South Hospital
Amiens, 80054, France
Service of Clinical Hematology - Bocage Hospital
Angers, 49033, France
Service of Clinical Hematology - Cote Basque Hospital
Bayonne, 64109, France
Service of Clinical Hematology - Minjoz Hospital
Besançon, 25030, France
Service of Clinical Hematology - Avicenne Hospital
Bobigny, 93009, France
Service of Clinical Hematology - A. Morvan Hospital
Brest, 29609, France
Service of Clinical Hematology - F. Baclesse Center
Caen, 14076, France
Service of Clinical Hematology - Army Instruction Hospital of Percy
Clamart, 92141, France
Service of Clinical Hematology - UH of Clermont-Ferrand
Clermont-Ferrand, 63003, France
Service of Oncohematology - Louis Pasteur Hospital
Colmar, 68024, France
Service of Hematology - Bocage Hospital
Dijon, 21034, France
Service of Hematology - General Hospital
Dunkirk, 59385, France
Service of Hematology - A. Michallon Hospital
Grenoble, 38043, France
Service of Hematology - Claude Hurriez Hospital
Lille, 59037, France
Service of Hematology - Léon Bérard Center
Lyon, 69008, France
Service of Hematology - Edouard Herriot Hospital
Lyon, 69437, France
Service of Hematology - Lyon Sud Hospital
Lyon, 69495, France
Service of Hematology - Paoli Calmette Institute
Marseille, 13273, France
Service of Hematology - Notre Dame du Bon Secours Hospital
Metz, 57038, France
Service of Blood Deseases - UH of Nantes
Nantes, 44035, France
Service of Clinical Hematology - Archet 1 Hospital
Nice, 06202, France
Service of Oncology - Archet 1 Hospital
Nice, 06202, France
Service of Hematology - Hotel Dieu
Paris, 75004, France
Service of Hematology - Cochin Hospital
Paris, 75014, France
Service of Blood Deseases - Saint Antoine Hospital
Paris, 75571, France
Service of Hematology - Jean Bernard Hospital
Poitiers, 86021, France
Service of Hematology - R.Debré Hospital
Reims, 51032, France
Service of Hematology - Pontchaillou Hospital
Rennes, 35033, France
Service of Hematology -Henri Becquerel Center
Rouen, 76038, France
Service of Hematology - Hautepierre Hospital
Strasbourg, 67098, France
Service of Clinical Hematology - Purpan hospital TSA 40031
Toulouse, 31059, France
Service of Onco-Hematology - Bretonneau Hospital
Tours, 37044, France
Service of Hematology - Brabois Hospital
Vandœuvre-lès-Nancy, 54511, France
Service of Hematology -Gustave Roussy Institute
Villejuif, 94805, France
Related Publications (1)
Roussel M, Moreau P, Huynh A, Mary JY, Danho C, Caillot D, Hulin C, Fruchart C, Marit G, Pegourie B, Lenain P, Araujo C, Kolb B, Randriamalala E, Royer B, Stoppa AM, Dib M, Dorvaux V, Garderet L, Mathiot C, Avet-Loiseau H, Harousseau JL, Attal M; Intergroupe Francophone du Myelome (IFM). Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myelome (IFM). Blood. 2010 Jan 7;115(1):32-7. doi: 10.1182/blood-2009-06-229658. Epub 2009 Nov 2.
PMID: 19884643RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murielle ROUSSEL, MD
Purpan Hospital - UH Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2008
First Posted
March 25, 2008
Study Start
July 1, 2007
Primary Completion
October 1, 2008
Study Completion
July 1, 2011
Last Updated
May 12, 2017
Record last verified: 2017-05