Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03606577
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-04-28
First Post:
2018-07-20
Brief Title:
An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients a Phase II Study of the Intergroupe Francophone du Myélome IFM 2018-04
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2020-07
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:
IFM 2018-04
Brief Summary:
According to international guidelines upfront therapy for transplant eligible myeloma patients should include triplet induction containing proteasome inhibitor and immunomodulatory agent autologous stem cell transplant PIImid based triplet consolidation and lenalidomide maintenance Despite this approach virtually all MM patients experience disease relapse especially those with High Risk disease defined by adverse cytogenetic abnormalities ie del17p or t1416 or t414 detected by FISH andor SNP arrays Indeed HR myeloma is associated with poorer progression free survival and overall survival and frontline therapy should therefore be improved for this subset of HR patients The primary objective of this prospective multicenter open label interventional phase 2 trial is to evaluate the feasibility of an intensive program including quadruplet induction and consolidation tandem autologous stem cell transplantation and maintenance in newly diagnosed multiple myeloma patients presenting with HR cytogenetic Quadruplet induction and consolidation include carfilzomib lenalidomide dexamethasone and daratumumab Maintenance will include lenalidomide and daratumumab Secondary objectives will include efficacy parameters ie response rate minimal residual disease safety progression free survival overall survival
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None