Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461747
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2007-04-17
Brief Title:
GEM05 for Patients With Multiple Myeloma Under 65 Years
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
A National Open-Label Multicenter Randomized Comparative Phase III Study of Induction Treatment With VBMCP-VBADVelcade Versus Thalidomide Dexamethasone Versus Velcade Thalidomide Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old
Status:
COMPLETED
Status Verified Date:
2009-09
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:
GEM05MENOS65
Brief Summary:
The primary objective is to compare safety and efficacy of three induction treatments VBMCP-VBAD Velcade versus Thalidomide Dexamethasone versus Velcade Thalidomide Dexamethasone The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant Otherwise this study wants to compare the safety and efficacy of the maintenance treatments Interferón a-2b versus Thalidomide versus ThalidomideVelcade
Detailed Description:
A total of up to 390 patients 65 years old diagnosed of Multiple Myeloma with symptomatic disease and that have not received previous chemotherapy for MM will be included
Patients will be evaluated at scheduled visits in up to three study periods Pre-treatment Treatment and Follow up
The Pre-treatment includes Screening and baseline visits After providing informed consent patients will be evaluated for study eligibility and then Patients will be randomized 111 to receive VBMCP-VBADVelcade Group A or ThalidomideDexamethasone Group B or ThalidomideDexamethasoneVelcade Group C All of them will received the induction treatment up to 24 weeks
After 4 weeks without progression or unacceptable toxicity There will be stem cell mobilization to do an autologous transplant Three months after transplant patients will be again randomized 111 to receive maintenance treatment Interferon-a Group M1 or Thalidomide Group M2 or ThalidomideVelcade Group M3 during three years
Once the treatment period has finished a follow up will be carry out During this period we will evaluated response progression-free survival and global survival every three months
Patients will be evaluated at scheduled visits in up to three study periods Pre-treatment Treatment and Follow up
The Pre-treatment includes Screening and baseline visits After providing informed consent patients will be evaluated for study eligibility and then Patients will be randomized 111 to receive VBMCP-VBADVelcade Group A or ThalidomideDexamethasone Group B or ThalidomideDexamethasoneVelcade Group C All of them will received the induction treatment up to 24 weeks
After 4 weeks without progression or unacceptable toxicity There will be stem cell mobilization to do an autologous transplant Three months after transplant patients will be again randomized 111 to receive maintenance treatment Interferon-a Group M1 or Thalidomide Group M2 or ThalidomideVelcade Group M3 during three years
Once the treatment period has finished a follow up will be carry out During this period we will evaluated response progression-free survival and global survival every three months
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