Ignite Creation Date:
2024-05-05 @ 11:25 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01325896
Status:
UNKNOWN
Last Update Posted:
2011-03-31
First Post:
2011-03-11
Brief Title:
Maintenance Treatment of Multiple Myeloma MM After Autologous Peripheral Blood Transplant PBSCT Using Polyethylene Glycol alpha2B Interpheron PEG-INTRON
Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Organization:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Overview
Official Title:
Maintenance Treatment of Multiple Myeloma MM After Autologous Peripheral Blood Transplant PBSCT Using Polyethylene Glycol alpha2B Interpheron PEG-INTRON
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
ACTIVE_NOT_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:
Multiple myeloma accounts for approximately 1 of all cancers and 10 of hematologic malignancies Between 50 and 70 of symptomatic patients presented response to induction chemotherapy The rate of complete responses CR achieved with standard induction of these treatments is less than 5 of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease
High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM However eventually all patients relapse with a median EFS between 40-50 months post-transplant
To improve these results and sustain remission various maintenance treatment have been proposed as is the case of Interpheron alpha2b sc Intron A that has shown benefits in a meta-analysis
Intron A sc need administration of 3 days per week and is not well tolerated
Recently a new formulation of Interpheron alpha2b is available Conjugated with polietilenglicol Pegintron that need only one dose weekly and has not been tested in MM
The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM
High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM However eventually all patients relapse with a median EFS between 40-50 months post-transplant
To improve these results and sustain remission various maintenance treatment have been proposed as is the case of Interpheron alpha2b sc Intron A that has shown benefits in a meta-analysis
Intron A sc need administration of 3 days per week and is not well tolerated
Recently a new formulation of Interpheron alpha2b is available Conjugated with polietilenglicol Pegintron that need only one dose weekly and has not been tested in MM
The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM
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