Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443235
Status:
COMPLETED
Last Update Posted:
2011-09-19
First Post:
2007-03-02
Brief Title:
GEM05 for Patients With Multiple Myeloma More Than 65 Years Old
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
A National Open-Label Multicenter Randomized Comparative Phase III Study of Induction Treatment With MelphalanPrednisoneVelcade Versus Thalidomide Prednisone Velcade and Maintenance Treatment With Thalidomide Velcade Versus Prednisone Velcade in Untreated Patients With Multiple Myeloma More Than 65 Years Old
Status:
COMPLETED
Status Verified Date:
2011-09
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:
None
Brief Summary:
The primary objective is to analyze and compare the efficacy the response rate the CR and the response rate duration of both induction treatments and both maintenance treatments
Detailed Description:
A total of up to 260 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 one to one to receive MelphalanPrednisoneVelcade Group A or ThalidomidePrednisoneVelcade Group B All of them will received the induction treatment up to 30 weeks After 4 weeks without progression and unacceptable toxicity Patients will be again randomized one to one to receive maintenance treatment ThalidomideVelcade Group M1 or PrednisoneVelcade Group M2 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 one to one to receive MelphalanPrednisoneVelcade Group A or ThalidomidePrednisoneVelcade Group B All of them will received the induction treatment up to 30 weeks After 4 weeks without progression and unacceptable toxicity Patients will be again randomized one to one to receive maintenance treatment ThalidomideVelcade Group M1 or PrednisoneVelcade Group M2 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