Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)

May 29, 2009 updated by: Intergroupe Francophone du Myelome

A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

Primary objective:

  • Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.

Secondary objectives:

  • Compare the following parameters following 4 cycles of VD or VTD induction treatment:

    • CR rate+ very good partial remission (VGPR) rate
    • Overall remission rate (CR + VGPR + partial remission (PR) rate)
    • K/l light chain ratio in patients in CR.
    • Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
  • Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 3

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

  • Belgium
      • Anvers, Belgium
        • ANVERS Centrumziekenhuis
      • Anvers, Belgium
        • Anvers Uza
      • Bruxelles, Belgium
        • Bruxelles Erasme
      • Bruxelles, Belgium
        • Bruxelles I Bordet
      • Bruxelles, Belgium
        • BRUXELLES St LUC
      • Gilly, Belgium
        • GILLY
      • Yvoir, Belgium
        • YVOIR MontGodinne
  • France
      • Angers, France
        • CHU Angers
      • Annecy, France
        • CH Annecy
      • Avignon, France
        • Ch Avignon
      • Bayonne, France
        • CH Bayonne
      • Besancon, France
        • CHU Besançon
      • Blois, France
        • CH Blois
      • Bobigny, France
        • Bobigny Avicenne
      • Bordeaux, France
        • Chu Bordeaux
      • Brest, France
        • CHU Brest
      • Caen, France
        • Caen M Interne Baclèse
      • Chartres, France
        • CH Chartres
      • Clamart, France
        • Clamart Percy
      • Clermont Ferrand, France
        • Chu Clermont Ferrand
      • Colmar, France
        • CH Colmar
      • Dijon, France
        • CHU Dijon
      • Dunkerque, France
        • Ch Dunkerque
      • Grenoble, France
        • CHU Grenoble
      • La Roche Sur Yon, France
        • CH La Roche sur Yon
      • Le Mans, France
        • Le Mans Victor Hugo
      • Lille, France
        • CHRU Lille
      • Lorient, France
        • CH Lorient
      • Lyon, France
        • CHU Lyon Edouard Herriot
      • Lyon, France
        • CHU Lyon Sud Pierre Bénite
      • Lyon, France
        • Lyon Léon Berard
      • Marseille, France
        • Marseille IPC
      • Metz, France
        • CHR Metz Bonsecours
      • Nancy, France
        • CHU Nancy
      • Nantes, France
        • CHU Nantes
      • Nantes, France
        • Nantes Catherine De Sienne
      • Nice, France
        • CHU Nice M Interne
      • Orleans, France
        • CHR Orléans
      • Paris, France
        • Paris Cochin
      • Paris, France
        • Paris Hôtel Dieu
      • Paris, France
        • Paris Necker
      • Paris, France
        • Paris St Antoine
      • Paris, France
        • Paris St Louis
      • Poitiers, France
        • CHU Poitiers hemato
      • Reims, France
        • Chu Reims
      • Rennes, France
        • CHU Rennes Hemato
      • Rennes, France
        • CHU Rennes M interne
      • Roanne, France
        • CH Roanne
      • Rouen, France
        • Rouen Becquerel
      • St Brieuc, France
        • CH St Brieuc
      • St ETIENNE, France
        • St Etienne
      • Strasbourg, France
        • CHRU Strasbourg
      • Toulouse, France
        • CHU Toulouse
      • Tours, France
        • CHU Tours
      • Valence, France
        • CH Valence
      • Vannes, France
        • CH Vannes

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:

  • Newly diagnosed symptomatic multiple myeloma (MM) patient
  • Aged under 65
  • Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
  • Using effective contraceptive methods (for fertile men, women of childbearing potential)
  • Provision of informed consent
  • No evidence of active infection

Exclusion Criteria:

  • Asymptomatic MM
  • Non-secretory MM
  • Aged 66 years or over
  • ECOG performance status over 2 (see Appendix 2)
  • Proven amyloidosis
  • A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer)
  • Positive HIV serology
  • A personal medical history of severe psychiatric disease
  • Severe diabetes contraindicating the use of high-dose dexamethasone
  • NCI grade ³ 2 peripheral neuropathy

  • Serum clinical chemistry:

    • creatinine level > 300 µmol/L or requiring dialysis
    • bilirubin, transaminases or GamaGT > 3 the upper normal limit (UNL)
  • Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization)
  • Radiation therapy in the 2 weeks preceding randomization
  • A personal medical history of allergic reactions to compounds containing boron or mannitol
  • Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure
  • Use of any investigational drug in the 30 days preceding randomization
  • Pregnant or lactating women; a serum Beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential
  • Severe pulmonary troubles (including acute infiltrative pneumopathy)

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Velcade-Dexamethasone
Drug: Velcade-Dexamethasone
ACTIVE_COMPARATOR: Velcade-Thalidomide-Dexamethasone
Drug: Velcade-Thalidomide-Dexamethasone

Collaborators and Investigators

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

Sponsor

Intergroupe Francophone du Myelome

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

March 1, 2008

Primary Completion (ANTICIPATED)

August 1, 2009

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (ESTIMATE)

June 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2009

Last Update Submitted That Met QC Criteria

May 29, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFM 2007-02
  • Eudract 2007-005204-40

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.

Clinical Trials on Multiple Myeloma

Clinical Trials on Velcade-Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe