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

May 10, 2017 updated by: University Hospital, Toulouse

Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
bortézomib
Drug: Bortezomib
bortezomib-Melphalan
Other Names:
  • Velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months after autologous stem cell transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Intergroupe Francophone du Myelome

Investigators

  • Principal Investigator: Murielle ROUSSEL, MD, Purpan Hospital - UH Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 13, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0603603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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