Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200681
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2005-09-12
Brief Title:
IFM 2005-01 VelcadeDexamethasone Versus VincristineAdriamycin DoxorubicinDexamethasone VAD for the Treatment of Patients With Multiple Myeloma
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Etude Multicentrique Ouverte Randomisée de Phase III Comparant lAssociation de VELCADE-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusquà lâge de 65 Ans
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Velcadedexamethasone combination as induction treatment plusminus dexamethasonecyclophosphamideetoposidecisplatin 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
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 mgl and the presence of chromosome 13 abnormalities identified by FISH analysis VAD VincristineAdriamycinDexamethasone DCEP DexamethasoneCyclophosphamide EtoposideCisplatin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None