Ignite Creation Date:
2024-05-06 @ 1:50 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01916252
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2013-07-30
Brief Title:
Bortezomib Velcade Lenalidomide Revlimid and IV Busulfan Busilvex in Patients Under 65 Years Old
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
A Randomized National Open-label Multicenter Phase III Trial Studying Induction Therapy With BortezomibLenalidomideDexamethasone VRD-GEM Followed by High-dose Chemotherapy With Melphalan-200 MEL-200 Versus Busulfan-melphalan BUMEL and Consolidation With VRD-GEM in Patients Under 65 Years Old With Newly-diagnosed Symptomatic Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2016-12
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:
GEM2012MENOS65
Brief Summary:
This protocol is a national multicenter comparative open-label randomized trial comparing the progression free survival PFS of two pre-transplant conditioning regimens BUMEL versus MEL-200
A total of 460 patients will be enrolled in the study Scheduled evaluations and study visits will take place during the pre-treatment treatment and follow-up periods
The pre-treatment period includes the screening visit in which participants provide informed consent in writing in order to take part in the study The patient is then assessed to determine hisher eligibility The selection process will begin 21 days before the first dose of medication is administered days -21 to 0 During the treatment period eligible patients will be included in the study and given six cycles of induction treatment with bortezomib lenalidomide dexamethasone VRD-GEM Each cycle will last 28 days during which SC bortezomib will be administered on days 1 4 8 and 11 oral lenalidomide on days 1-21 of each cycle and oral dexamethasone on days 1-4 and 9-12 of the cycle
After the first three induction cycles and in the absence of progression or unacceptable toxicity peripheral blood hematopoietic stem cells will be mobilized and collected using G-CSF for later autologous transplantation Patients will be randomized in a 11 allocation ratio to receive conditioning treatment with MEL-200 versus BUMEL Randomization will take place at the beginning of the study once the screening is complete and the patients eligibility verified Three months after transplantation patients will receive two cycles of consolidation treatment with VRD-GEM at the same doses administered during induction treatment
Once the treatment phase is complete patients will begin the follow-up phase in which they will be visited every three months to evaluate disease progression and survival
A total of 460 patients will be enrolled in the study Scheduled evaluations and study visits will take place during the pre-treatment treatment and follow-up periods
The pre-treatment period includes the screening visit in which participants provide informed consent in writing in order to take part in the study The patient is then assessed to determine hisher eligibility The selection process will begin 21 days before the first dose of medication is administered days -21 to 0 During the treatment period eligible patients will be included in the study and given six cycles of induction treatment with bortezomib lenalidomide dexamethasone VRD-GEM Each cycle will last 28 days during which SC bortezomib will be administered on days 1 4 8 and 11 oral lenalidomide on days 1-21 of each cycle and oral dexamethasone on days 1-4 and 9-12 of the cycle
After the first three induction cycles and in the absence of progression or unacceptable toxicity peripheral blood hematopoietic stem cells will be mobilized and collected using G-CSF for later autologous transplantation Patients will be randomized in a 11 allocation ratio to receive conditioning treatment with MEL-200 versus BUMEL Randomization will take place at the beginning of the study once the screening is complete and the patients eligibility verified Three months after transplantation patients will receive two cycles of consolidation treatment with VRD-GEM at the same doses administered during induction treatment
Once the treatment phase is complete patients will begin the follow-up phase in which they will be visited every three months to evaluate disease progression and survival
Detailed Description:
None
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