Ignite Creation Date:
2024-05-05 @ 9:41 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00948922
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2009-07-28
Brief Title:
MelphalanBortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Evaluation of MelphalanBortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy
Status:
COMPLETED
Status Verified Date:
2019-06
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 purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicines for treatment of Multiple Myeloma
Detailed Description:
The primary objectives of this study are
To determine the 2 year-progression free survival in multiple myeloma with an allogeneic transplant using a conditioning regimen of melphalan fludarabine Bortezomib in patients 60 years of age and available HLA-matched donor and compare it with the 2 year-progression-free-survival after an autologous stem cell transplant with melphalanBortezomib conditioning in patients 60 years
To determine the 2 year-progression free survival in multiple myeloma with an autologous stem cell transplant using a conditioning regimen of melphalan Bortezomib for patients 60 years of age and patients 60 years of age who decline allogeneic stem cell transplant
The secondary objectives of this study are
To determine the overall survival in multiple myeloma with autologous or allogeneic stem cell transplants using the above conditioning regimens
To determine the response rates in multiple myeloma using the above regimens
To determine minimal residual disease status using allele specific oligonucleotides ASO-PCR by PCR and flow-cytometry for multiple myeloma cells
To correlate minimal residual disease status with 2 year progression free survival and overall survival
To determine the incidence of acute and chronic graft-versus-host disease GVHD in multiple myeloma with allogeneic stem cell transplant using the above conditioning regimen
To examine quality of life in patients treated with allogeneic and autologous stem cell transplants using the above conditioning regimen
To determine the 2 year-progression free survival in multiple myeloma with an allogeneic transplant using a conditioning regimen of melphalan fludarabine Bortezomib in patients 60 years of age and available HLA-matched donor and compare it with the 2 year-progression-free-survival after an autologous stem cell transplant with melphalanBortezomib conditioning in patients 60 years
To determine the 2 year-progression free survival in multiple myeloma with an autologous stem cell transplant using a conditioning regimen of melphalan Bortezomib for patients 60 years of age and patients 60 years of age who decline allogeneic stem cell transplant
The secondary objectives of this study are
To determine the overall survival in multiple myeloma with autologous or allogeneic stem cell transplants using the above conditioning regimens
To determine the response rates in multiple myeloma using the above regimens
To determine minimal residual disease status using allele specific oligonucleotides ASO-PCR by PCR and flow-cytometry for multiple myeloma cells
To correlate minimal residual disease status with 2 year progression free survival and overall survival
To determine the incidence of acute and chronic graft-versus-host disease GVHD in multiple myeloma with allogeneic stem cell transplant using the above conditioning regimen
To examine quality of life in patients treated with allogeneic and autologous stem cell transplants using the above conditioning regimen
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 |
|---|---|---|---|
| XO5271 | OTHER_GRANT | Millennium | None |