Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307086
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2006-03-23
Brief Title:
Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
An Evaluation of Bortezomib VelcadeR Followed by High-Dose Melphalan and Bortezomib VelcadeR as Conditioning Regimen for Tandem Peripheral Blood Stem Cell Transplants in Patients With Primary Refractory Multiple Myeloma and Plasma Cell Leukemia
Status:
COMPLETED
Status Verified Date:
2013-08
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:
The primary objectives of this study are to
To determine the maximum tolerated dose MTD of bortezomib in combination with high-dose melphalan as a conditioning regimen
To determine the safety tolerability and response rates of bortezomib given in combination with high-dose melphalan as a conditioning regimen for tandem transplants in patients with primary refractory multiple myeloma or plasma cell leukemia
The secondary objectives of this study are to
To determine gene expression profiles pharmacogenomics and perform RTPCR for Fanconi anemia pathway genes prior to and after treatment with bortezomib in patients with primary refractory multiple myeloma and plasma cell leukemia and correlate profiles with responses to treatment
To determine the time to disease progression and overall survival in patients with primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib followed by tandem autologous transplantation
To determine the response rates of 2 cycles of bortezomib in patients with primary refractory multiple myeloma or plasma cell leukemia
To determine the maximum tolerated dose MTD of bortezomib in combination with high-dose melphalan as a conditioning regimen
To determine the safety tolerability and response rates of bortezomib given in combination with high-dose melphalan as a conditioning regimen for tandem transplants in patients with primary refractory multiple myeloma or plasma cell leukemia
The secondary objectives of this study are to
To determine gene expression profiles pharmacogenomics and perform RTPCR for Fanconi anemia pathway genes prior to and after treatment with bortezomib in patients with primary refractory multiple myeloma and plasma cell leukemia and correlate profiles with responses to treatment
To determine the time to disease progression and overall survival in patients with primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib followed by tandem autologous transplantation
To determine the response rates of 2 cycles of bortezomib in patients with primary refractory multiple myeloma or plasma cell leukemia
Detailed Description:
Patients with primary refractory multiple myeloma or plasma cell leukemia either newly diagnosed or previously treated will receive 2-cycles of standard dose bortezomib followed by high-dose melphalan and bortezomib as a conditioning regimen prior to a tandem autologous peripheral blood stem cell transplantation PBSCT Following treatment with two cycles of standard dose bortezomib sequential cohorts of patients will be given escalating bortezomib doses combined with standard and constant conditioning regimen doses of melphalan Once the MTD of bortezomib is reached that dose will be administered in combination with melphalan as conditioning prior to PBSCT
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 |
|---|---|---|---|
| X05174 | None | None | None |