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IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200681
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 5, 2009
Information provided by:
Nantes University Hospital

Brief Summary:
This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Velcade Phase 3

Detailed Description:
After their written informed consent has been obtained and their eligibility verified, patients are randomised between 4 treatment arms: A1 VAD (4 cycles); A2 VAD (4 cycles) followed by DCEP (2 cycles); B1 Velcade® + dexamethasone (4 cycles); B2 Velcade® + dexamethasone (4 cycles) followed by DCEP (2 cycles) A1, A2, B1, B2 + autograft. Randomisation will be stratified on the basis of the initial b2 microglobulin level (> or < 3 mg/l) and the presence of chromosome 13 abnormalities identified by FISH analysis. VAD: Vincristine/Adriamycin/Dexamethasone; DCEP: Dexamethasone/Cyclophosphamide/ Etoposide/Cisplatin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 493 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans
Study Start Date : June 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Primary Outcome Measures :
  1. To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recently diagnosed MM according to the criteria of the South West Oncology Group (SWOG)
  • Not previously treated, apart from local radiotherapy, in the case of a threatening or incapacitating lesion, and/or a 4-day block of dexamethasone (40 mg/mL) in an emergency
  • Stage II or III disease according to the Durie and Salmon classification or Stage I disease with symptomatic bone lesion
  • < 65 years of age
  • Ability to give signed informed consent
  • Secretion of a measurable monoclonal spike (> 10 g/l in the serum or 0.2 g/24h in the urine)
  • Negative pregnancy test at inclusion (if necessary)
  • Absence of active infection. In the case of infection, appropriate antibiotic therapy must be administered and patients must have been apyretic for 48 hours before the start of treatment with VAD or Velcade®/dexamethasone

Exclusion Criteria:

  • ECOG performance status > 2
  • History of cancer (other than basal cell carcinoma or carcinoma of the cervix in situ)
  • Life expectancy < 2 months
  • Confirmed amyloidosis
  • Positive HIV serology
  • Serious psychiatric item in the history
  • Renal failure requiring dialysis
  • Uncontrolled diabetes, contra-indicating the use of corticosteroids
  • Peripheral neuropathy National Cancer Institute (NCI) grade > 2 (Annex 5)
  • Clinical signs of heart failure or coronary heart disease
  • Bilirubin > 3 x normal
  • Transaminases or gamma-glutamyl transpeptidase (GT) > 4 x normal
  • Platelets < 50 x 10^9/l during the 15 days prior to inclusion
  • Neutrophils < 0.75 x 10^9/l during the 15 days prior to inclusion
  • Use of an investigational medicinal product during the 30 days prior to inclusion
  • Known hypersensitivity to bortezomib, boron or mannitol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200681

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CHU de Nantes, Service d'Hématologie
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Jean-Luc Harousseau, MD PHD Intergroupe Francophone du Myélome (IFM)
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00200681    
Other Study ID Numbers: BRD 04/11-J
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009
Keywords provided by Nantes University Hospital:
Secretory Multiple Myeloma
First line treatment
Newly diagnosed secretory Multiple Myeloma (MM)
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents