Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)

This study has been completed.
Sponsor:
Collaborator:
Intergroupe Francophone du Myelome
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00642395
First received: March 13, 2008
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Evaluate the Complete Response and Very Good Partial Response (VGPR) rates 3 months after autologous blood stem cell transplantation conditioned by Velcade-Melphalan [ Time Frame: 3 months after autologous stem cell transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: July 2007
Study Completion Date: July 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
bortézomib
Drug: Bortezomib
bortezomib-Melphalan
Other Name: Velcade

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642395

Locations
France
Service of Blood Deseases - South Hospital
Amiens, France, 80054
Service of Clinical Hematology - Bocage Hospital
Angers, France, 49033
Service of Clinical Hematology - Cote Basque Hospital
Bayonne, France, 64109
Service of Clinical Hematology - Minjoz Hospital
Besançon, France, 25030
Service of Clinical Hematology - Avicenne Hospital
Bobigny, France, 93009
Service of Clinical Hematology - A. Morvan Hospital
Brest, France, 29609
Service of Clinical Hematology - F. Baclesse Center
Caen, France, 14076
Service of Clinical Hematology - Army Instruction Hospital of Percy
Clamart, France, 92141
Service of Clinical Hematology - UH of Clermont-Ferrand
Clermont-Ferrand, France, 63003
Service of Oncohematology - Louis Pasteur Hospital
Colmar, France, 68024
Service of Hematology - Bocage Hospital
Dijon, France, 21034
Service of Hematology - General Hospital
Dunkerque, France, 59385
Service of Hematology - A. Michallon Hospital
Grenoble, France, 38043
Service of Hematology - Claude Hurriez Hospital
Lille, France, 59037
Service of Hematology - Léon Bérard Center
Lyon, France, 69008
Service of Hematology - Edouard Herriot Hospital
Lyon, France, 69437
Service of Hematology - Lyon Sud Hospital
Lyon, France, 69495
Service of Hematology - Paoli Calmette Institute
Marseille, France, 13273
Service of Hematology - Notre Dame du Bon Secours Hospital
Metz, France, 57038
Service of Blood Deseases - UH of Nantes
Nantes, France, 44035
Service of Clinical Hematology - Archet 1 Hospital
Nice, France, 06202
Service of Oncology - Archet 1 Hospital
Nice, France, 06202
Service of Hematology - Hotel Dieu
Paris, France, 75004
Service of Blood Deseases - Saint Antoine Hospital
Paris, France, 75571
Service of Hematology - Cochin Hospital
Paris, France, 75014
Service of Hematology - Jean Bernard Hospital
Poitiers, France, 86021
Service of Hematology - R.Debré Hospital
Reims, France, 51032
Service of Hematology - Pontchaillou Hospital
Rennes, France, 35033
Service of Hematology -Henri Becquerel Center
Rouen, France, 76038
Service of Hematology - Hautepierre Hospital
Strasbourg, France, 67098
Service of Clinical Hematology - Purpan hospital TSA 40031
Toulouse, France, 31059
Service of Onco-Hematology - Bretonneau Hospital
Tours, France, 37044
Service of Hematology - Brabois Hospital
Vandoeuvre, France, 54511
Service of Hematology -Gustave Roussy Institute
Villejuif, France, 94805
Sponsors and Collaborators
University Hospital, Toulouse
Intergroupe Francophone du Myelome
Investigators
Principal Investigator: Murielle ROUSSEL, MD Purpan Hospital - UH Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00642395     History of Changes
Other Study ID Numbers: 0603603
Study First Received: March 13, 2008
Last Updated: October 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Multiple Myeloma
Autologous Stem Cells Transplantation
High Dose Melphalan
Bortezomib

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Melphalan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014