Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504634
Status:
COMPLETED
Last Update Posted:
2011-09-15
First Post:
2007-07-18
Brief Title:
Bortezomib Velcade Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Trial of Bortezomib Velcade After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
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:
Primary Objective
1 To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma
Secondary Objective
1 To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation
1 To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma
Secondary Objective
1 To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation
Detailed Description:
Bortezomib velcade is a new drug that works by blocking a structure in the cells called proteasome This proteasome acts like a system that eliminates abnormal or old proteins from the cells Cancer cells may be sensitive to drugs like bortezomib velcade because tumor cells have more abnormal proteins than normal cells Bortezomib velcade enters the tumor cells and affects the way they divide When cancer cells cannot divide they die
You will have blood about 2 tablespoons and bone marrow testing done about every 2-3 months to determine your response and tolerance to treatment To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
You will receive bortezomib velcade as an infusion into a vein over 5-10 minutes twice a week for 2 weeks You will then rest for 10 to 17 days This 21-28 day period makes up 1 cycle You will complete up to a total of 4 cycles Courses 2 and 3 might be given under supervision of your local physician however the principal investigator will do necessary treatment dose adjustments and new set of treatment orders will be provided to your physician Treatment evaluations will be under the supervision of the principal investigator
You will have a physical exam and routine blood tests about 2 tablespoons before each dose of bortezomib velcade Blood about 2 tablespoons and urine tests to determine response to treatment will be performed once a month as well as blood tests to look at side effects of treatment will be performed at least once a week and more frequently if medically necessary
You will be taken off study if the disease gets worse or intolerable side effects occur You will be called every 3 months for at least 1 year after the last dose of bortezomib velcade to see how you are doing
This is an investigational study Bortezomib velcade is commercially available and indicated for the treatment of myeloma A total of 28 patients will participate in this study All will be enrolled at M D Anderson
You will have blood about 2 tablespoons and bone marrow testing done about every 2-3 months to determine your response and tolerance to treatment To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
You will receive bortezomib velcade as an infusion into a vein over 5-10 minutes twice a week for 2 weeks You will then rest for 10 to 17 days This 21-28 day period makes up 1 cycle You will complete up to a total of 4 cycles Courses 2 and 3 might be given under supervision of your local physician however the principal investigator will do necessary treatment dose adjustments and new set of treatment orders will be provided to your physician Treatment evaluations will be under the supervision of the principal investigator
You will have a physical exam and routine blood tests about 2 tablespoons before each dose of bortezomib velcade Blood about 2 tablespoons and urine tests to determine response to treatment will be performed once a month as well as blood tests to look at side effects of treatment will be performed at least once a week and more frequently if medically necessary
You will be taken off study if the disease gets worse or intolerable side effects occur You will be called every 3 months for at least 1 year after the last dose of bortezomib velcade to see how you are doing
This is an investigational study Bortezomib velcade is commercially available and indicated for the treatment of myeloma A total of 28 patients will participate in this study All will be enrolled at M D Anderson
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