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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200681
• Other study ID #: BRD 04/11-J
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: February 4, 2009
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: February 2009
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: June 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Velcade

Locations

Country	Name	City	State
France	CHU de Nantes, Service d'Hématologie	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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