Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256776
Status:
TERMINATED
Last Update Posted:
2021-10-18
First Post:
2005-11-21
Brief Title:
MMVAR - Velcade Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation
Sponsor:
European Society for Blood and Marrow Transplantation
Organization:
European Society for Blood and Marrow Transplantation
Study Overview
Official Title:
A Randomized Controlled Study of Velcade Bortezomib Plus Thalidomide Plus Dexamethasone Compared to Thalidomide Plus Dexamethasone for the Treatment of Myeloma Patients Progressing or Relapsing After Autologous Transplantation
Status:
TERMINATED
Status Verified Date:
2021-09
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:
This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed or relapsed at least one year after transplantation
Eligible patients will be randomly assigned to one of two treatments either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone
Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma especially in relapsed patients This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression measure of time after the disease is treated until it starts to get worse than Thalidomide plus Dexamethasone alone
Eligible patients will be randomly assigned to one of two treatments either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone
Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma especially in relapsed patients This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression measure of time after the disease is treated until it starts to get worse than Thalidomide plus Dexamethasone alone
Detailed Description:
Primary Objectives
Test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination will result in a longer time to progression TTP than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation
Secondary Objectives
Compare the treatment groups for overall survival response rate complete partial minimal using standard criteria and treatment related complications
Study design and methodology
This is a prospective randomized parallel-group open-label phase III on an intention to treat multicenter study The main endpoint is time-to-failure TTPtime to progression The power is based on an initial assumption of a median TTP of 15 years in the experimental Velcade group and 1 year in the control group The design of the study is group sequential There will be 4 interim analyses and one final analysis The study is designed to have a priori 90 power to detect the clinically relevant difference at completion of the study at 0025 level Patients with multiple myeloma whose disease has either progressed or relapsed at least one year after one or two autologous transplantations will be enrolled Prior to random assignment subjects will be stratified on center and number of autologous transplantsSubjects will be randomly assigned to treatment in a 1 1 allocation within each stratum to Velcade plus Thalidomide plus Dexamethasone VTD or Thalidomide plus Dexamethasone Velcade 13 mgm2 will be given as an iv bolus on Days 1 4 8 and 11 followed by a 10-day rest period Days 12 to 21 for 8 cycles 6 months and then on Days 1 8 15 and 22 followed by a 20-day rest period Days 23 to 42 for 4 cycles 6 months In both arms Thalidomide will be given at 200 mgday per os for one year and Dexamethasone 40 mgday per os four days every three weeks for one yearTreatment will continue until disease progression or the occurrence of unacceptable treatment-related toxicity or up to a total of 12 cycles of Velcade except for those subjects who have a continuing decrease in the levels of paraprotein after 12 cycles These subjects may continue for as long as treatment is tolerated and they continue to respond If a subject has a CR then treatment should continue at least 2 cycles after the objective response is confirmed For subjects with a PR or stable disease treatment may continue after a maximum objective response is confirmed unless the subject experiences unacceptable treatment-related toxicity or the subject has completed 12 cycles of treatment Disease assessment will occur at the start of each cycle If a subject discontinues treatment without disease progression disease assessment will be performed every 3 weeks for 48-weeks from the start of the first dose of study entry drug Subjects who have not progressed at the end of 48-week follow up period will be assessed every 6 weeks until disease progression is documented
Test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination will result in a longer time to progression TTP than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation
Secondary Objectives
Compare the treatment groups for overall survival response rate complete partial minimal using standard criteria and treatment related complications
Study design and methodology
This is a prospective randomized parallel-group open-label phase III on an intention to treat multicenter study The main endpoint is time-to-failure TTPtime to progression The power is based on an initial assumption of a median TTP of 15 years in the experimental Velcade group and 1 year in the control group The design of the study is group sequential There will be 4 interim analyses and one final analysis The study is designed to have a priori 90 power to detect the clinically relevant difference at completion of the study at 0025 level Patients with multiple myeloma whose disease has either progressed or relapsed at least one year after one or two autologous transplantations will be enrolled Prior to random assignment subjects will be stratified on center and number of autologous transplantsSubjects will be randomly assigned to treatment in a 1 1 allocation within each stratum to Velcade plus Thalidomide plus Dexamethasone VTD or Thalidomide plus Dexamethasone Velcade 13 mgm2 will be given as an iv bolus on Days 1 4 8 and 11 followed by a 10-day rest period Days 12 to 21 for 8 cycles 6 months and then on Days 1 8 15 and 22 followed by a 20-day rest period Days 23 to 42 for 4 cycles 6 months In both arms Thalidomide will be given at 200 mgday per os for one year and Dexamethasone 40 mgday per os four days every three weeks for one yearTreatment will continue until disease progression or the occurrence of unacceptable treatment-related toxicity or up to a total of 12 cycles of Velcade except for those subjects who have a continuing decrease in the levels of paraprotein after 12 cycles These subjects may continue for as long as treatment is tolerated and they continue to respond If a subject has a CR then treatment should continue at least 2 cycles after the objective response is confirmed For subjects with a PR or stable disease treatment may continue after a maximum objective response is confirmed unless the subject experiences unacceptable treatment-related toxicity or the subject has completed 12 cycles of treatment Disease assessment will occur at the start of each cycle If a subject discontinues treatment without disease progression disease assessment will be performed every 3 weeks for 48-weeks from the start of the first dose of study entry drug Subjects who have not progressed at the end of 48-week follow up period will be assessed every 6 weeks until disease progression is documented
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EBMT-CLWP 42206611 | None | None | None |