Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00271804
Status:
TERMINATED
Last Update Posted:
2008-03-13
First Post:
2005-12-30
Brief Title:
Study of Velcade and Thalidomide in Patients With Myelodysplasia
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia
Status:
TERMINATED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New study with lenalidomide pending
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia
Detailed Description:
Initial studies using Velcade in myelodysplasia with early results demonstrating that 35 had a partial response and 25 had stable disease The combination of Velcade and thalidomide has been studied in patients with multiple myeloma but not in patients with myelodysplasia The CRR in the MM patients was 22 with a good safety profile
This is a phase 1 prospective open-label dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia Treatment will be given as an outpatient Patients will receive 4 days of Velcade days 1 4 8 11 and 21 days of thalidomide 50 mgday for each 21 day cycle There will be 3 cohorts of 3-6 patients each plus 10 additional patients The tree dose levels ill be 07 10 and 13 mgm2 Patients may continue to be treated up to 6 cycles Cycles 2-6 will start within 2 weeks of completion of the previous cycle Disease response will be evaluated after cycle 3 and 6
This is a phase 1 prospective open-label dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia Treatment will be given as an outpatient Patients will receive 4 days of Velcade days 1 4 8 11 and 21 days of thalidomide 50 mgday for each 21 day cycle There will be 3 cohorts of 3-6 patients each plus 10 additional patients The tree dose levels ill be 07 10 and 13 mgm2 Patients may continue to be treated up to 6 cycles Cycles 2-6 will start within 2 weeks of completion of the previous cycle Disease response will be evaluated after cycle 3 and 6
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