Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01255527
Status:
UNKNOWN
Last Update Posted:
2013-06-04
First Post:
2010-12-06
Brief Title:
Evaluating the Efficacy and Safety of the Lower Dose of Bortezomib Plus Busulfan and Melphalan as a Conditioning Regimen in Patients With Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplantation- KMM103 Study
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Phase 12 Open-label Prospective Multicenter Study to Evaluate the Efficacy and Safety of the Lower Dose of Bortezomib Plus Busulfan and Melphalan as a Conditioning Regimen in Patients With Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplantation- KMM103 Study
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
RECRUITING
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:
Despite the advantages of autologous stem cell transplantation ASCT over conventional chemotherapy12 the results of high-dose chemoradiotherapy in multiple myeloma MM are still unsatisfactory with a 6-year event free survival EFS of only 24
Based on existing data bortezomib-containing regimens are currently accepted at many centers as an induction treatment option for patients with symptomatic MM particularly if it is planned to offer subsequent high-dose therapy with ASCT So we will use bortezomib-containing regimens as induction prior to this novel conditioning regimen The objective of the present study is to compare the toxicity and therapeutic efficacy of a new high-dose regimen using dose-escalation of BOR BU and MEL for ASCT in the Korean patients with MM The patients should be treated with bortezomib-containing regimens as an induction therapy before ASCT We will specifically analyze i the efficacy of the conditioning regimen in improving the pre-ASCT status response rate ii engraftment and transplant-related mortality TRM and iii the impact on survival including progression-free survival PFS and overall survival OS
Triple combination of conditioning will enhance the response rate after ASCT and will improve not only PFS but also OS We think that data from this study may further strengthen feasibility of BOR in conditioning prior to ASCT
Based on existing data bortezomib-containing regimens are currently accepted at many centers as an induction treatment option for patients with symptomatic MM particularly if it is planned to offer subsequent high-dose therapy with ASCT So we will use bortezomib-containing regimens as induction prior to this novel conditioning regimen The objective of the present study is to compare the toxicity and therapeutic efficacy of a new high-dose regimen using dose-escalation of BOR BU and MEL for ASCT in the Korean patients with MM The patients should be treated with bortezomib-containing regimens as an induction therapy before ASCT We will specifically analyze i the efficacy of the conditioning regimen in improving the pre-ASCT status response rate ii engraftment and transplant-related mortality TRM and iii the impact on survival including progression-free survival PFS and overall survival OS
Triple combination of conditioning will enhance the response rate after ASCT and will improve not only PFS but also OS We think that data from this study may further strengthen feasibility of BOR in conditioning prior to ASCT
Detailed Description:
None
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