Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05835726
Status:
RECRUITING
Last Update Posted:
2023-05-01
First Post:
2023-04-19
Brief Title:
Daratumumab-containing Induction Effects on Stem Cells Mobilization colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Daratumumab-containing Induction Effects on Stem Cells Mobilization colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients DILEMMA
Status:
RECRUITING
Status Verified Date:
2023-04
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:
DILEMMA
Brief Summary:
Daratumumab is a human first-in-class monoclonal antibody that targets a cluster of differentiation CD 38 a cell surface protein that is overexpressed on multiple myeloma MM cells showing significant activity in relapsedrefractory disease More recently it was demonstrated that the addition of daratumumab to pre-autologous hematopoietic stem cell transplant ASCT induction regimens in newly diagnosed multiple myeloma increased the rate of complete responses and disease-free survival However in consideration of the expression of CD38 antigen also by stem cells daratumumab could exert effects on their mobilization collection and engraftment The primary objective of this retrospectiveprospective observational study is to investigate the impact of adding daratumumab to standard induction regimens VTDbortezomib-thalidomide and dexamethasone VD bortezomib and dexamethasone on stem cell mobilization in patients with newly diagnosed multiple myeloma NDMM who are candidates for ASCT
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