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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00200681

Collaborator

(none)

493

Enrollment

Location

Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2005

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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