Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128921
Status:
TERMINATED
Last Update Posted:
2012-04-26
First Post:
2005-08-08
Brief Title:
Study of Velcade and Bone Formation in Patients With RelapsedRefractory Multiple Myeloma
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
A Phase II Dose-Response Study of Velcade and Bone Formation in Patients With RelapsedRefractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study terminated due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Velcade bortezomib PS-341 has recently been approved by the Food and Drug Administration FDA for the treatment of multiple myeloma for patients who have received at least one prior therapy Velcade is a unique compound developed by scientists at Millennium Pharmaceuticals Inc Velcade enters cells and affects the way they divide Cancer cells are particularly sensitive Velcade interferes with the enzyme proteasome which is responsible for allowing cells to divide When cancer cells cannot divide they die Velcade falls into the class of drugs known as proteasome inhibitors
Detailed Description:
Studies at the Myeloma Institute for Research Therapy have shown that Velcade is very effective in treating patients who are relapsing after having been treated with at least two lines of prior therapy
One key factor in multiple myeloma is bone destruction caused by the myeloma cells Most patients with multiple myeloma 80 will develop skeletal lesions despite treatment These lesions are rarely repaired even when the myeloma is in remission
Experience at MIRT has suggested that Velcade may increase osteoblast bone cells that cause bone growth activity One goal of this study is to identify if Velcades effect on myeloma is due to its ability to increase osteoblasts
This study also has the following goals
To find out the lowest dose of Velcade that has an effect on myeloma and also increases bone activation
To identify ways to predict if Velcade will increase bone activation
Time periods are
According to cohort assignment you will receive three cycles of Velcade 13 mgm2 10 mgm2 or 07 mgm2 on days 1 4 8 and 11 on a 21-day cycle
During the first two cycles of Velcade bone markers tests on your bones will be measured Days 1 4 8 11 Pre-dose post-dose and every 2 to 4 hours for 8 hours
Days 2-3 5-7 9-10 12-21 every 24 hours beginning with the immediate post-dose sample - 2 hours
During the third cycle of Velcade bone markers will be measured Days 1 and 11 Pre-dose and post-dose and then again on Day 21
One key factor in multiple myeloma is bone destruction caused by the myeloma cells Most patients with multiple myeloma 80 will develop skeletal lesions despite treatment These lesions are rarely repaired even when the myeloma is in remission
Experience at MIRT has suggested that Velcade may increase osteoblast bone cells that cause bone growth activity One goal of this study is to identify if Velcades effect on myeloma is due to its ability to increase osteoblasts
This study also has the following goals
To find out the lowest dose of Velcade that has an effect on myeloma and also increases bone activation
To identify ways to predict if Velcade will increase bone activation
Time periods are
According to cohort assignment you will receive three cycles of Velcade 13 mgm2 10 mgm2 or 07 mgm2 on days 1 4 8 and 11 on a 21-day cycle
During the first two cycles of Velcade bone markers tests on your bones will be measured Days 1 4 8 11 Pre-dose post-dose and every 2 to 4 hours for 8 hours
Days 2-3 5-7 9-10 12-21 every 24 hours beginning with the immediate post-dose sample - 2 hours
During the third cycle of Velcade bone markers will be measured Days 1 and 11 Pre-dose and post-dose and then again on Day 21
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