Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349778
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2006-07-05
Brief Title:
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-11
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:
This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma The study is being performed to evaluate the efficacy and side effects of treatment Specifically the study is designed to reduce the risk of interstitial pneumonitis
Detailed Description:
Analysis of 196 previously treated patients demonstrated a median event-free survival EFS of 36 months with a median overall survival of more than 6 years The main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis IP This complication is related to the dose of carmustine Institutional experience in myeloma patients using this dose of carmustine indicates an incidence of IP of34
There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill decreased tumor burden and an improvement in overall survival Our results with high-dose sequential therapy including the dose-intense carmustinemelphalan transplant demonstrates similar median EFS and overall survival OS when compared with the results of tandem transplant approachesThe proposed trial will continue to use a high-dose sequential transplant approach however we will use a reduced dose of carmustine which we expect to be associated with a lower incidence of IP
There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill decreased tumor burden and an improvement in overall survival Our results with high-dose sequential therapy including the dose-intense carmustinemelphalan transplant demonstrates similar median EFS and overall survival OS when compared with the results of tandem transplant approachesThe proposed trial will continue to use a high-dose sequential transplant approach however we will use a reduced dose of carmustine which we expect to be associated with a lower incidence of IP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMT183 | OTHER | OnCore number | None |
| 97115 | OTHER | None | None |