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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Besancon
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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