Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)
NCT ID: NCT00642395
Last Updated: 2017-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2007-07-31
2011-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
bortézomib
Bortezomib
bortezomib-Melphalan
Interventions
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Bortezomib
bortezomib-Melphalan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Intergroupe Francophone du Myelome
NETWORK
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Murielle ROUSSEL, MD
Role: PRINCIPAL_INVESTIGATOR
Purpan Hospital - UH Toulouse
Locations
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Service of Blood Deseases - South Hospital
Amiens, , France
Service of Clinical Hematology - Bocage Hospital
Angers, , France
Service of Clinical Hematology - Cote Basque Hospital
Bayonne, , France
Service of Clinical Hematology - Minjoz Hospital
Besançon, , France
Service of Clinical Hematology - Avicenne Hospital
Bobigny, , France
Service of Clinical Hematology - A. Morvan Hospital
Brest, , France
Service of Clinical Hematology - F. Baclesse Center
Caen, , France
Service of Clinical Hematology - Army Instruction Hospital of Percy
Clamart, , France
Service of Clinical Hematology - UH of Clermont-Ferrand
Clermont-Ferrand, , France
Service of Oncohematology - Louis Pasteur Hospital
Colmar, , France
Service of Hematology - Bocage Hospital
Dijon, , France
Service of Hematology - General Hospital
Dunkirk, , France
Service of Hematology - A. Michallon Hospital
Grenoble, , France
Service of Hematology - Claude Hurriez Hospital
Lille, , France
Service of Hematology - Léon Bérard Center
Lyon, , 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 Blood Deseases - UH of Nantes
Nantes, , France
Service of Clinical Hematology - Archet 1 Hospital
Nice, , France
Service of Oncology - Archet 1 Hospital
Nice, , France
Service of Hematology - Hotel Dieu
Paris, , France
Service of Hematology - Cochin Hospital
Paris, , France
Service of Blood Deseases - Saint Antoine Hospital
Paris, , 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 Hematology -Henri Becquerel Center
Rouen, , France
Service of Hematology - Hautepierre Hospital
Strasbourg, , France
Service of Clinical Hematology - Purpan hospital TSA 40031
Toulouse, , France
Service of Onco-Hematology - Bretonneau Hospital
Tours, , France
Service of Hematology - Brabois Hospital
Vandœuvre-lès-Nancy, , France
Service of Hematology -Gustave Roussy Institute
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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0603603
Identifier Type: -
Identifier Source: org_study_id
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