Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03168100
Status:
WITHDRAWN
Last Update Posted:
2019-01-28
First Post:
2017-05-24
Brief Title:
2017-03 A Single-Arm Open-label Study of Anti-Signaling Lymphocytic Activation Molecule F7 Anti-SLAMF7 Monoclonal Antibody mAb Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
University of Arkansas UARK 2017-03 A Single-Arm Open-label Study of Anti-SLAMF7 mAb Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma Total Therapy 8
Status:
WITHDRAWN
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No study population No subjects enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated great improvement in treatment outcomes for multiple myeloma patients However some patients still relapse early during maintenance treatment meaning that better options are still needed This study will evaluate a treatment regimen that alternates two different 3-drug regimens every eight weeks for patients that have previously completed autologous stem cell transplant The two regimens are bortezomib lenalidomide and dexamethasone VRD which will be alternated with Elotuzumab lenalidomide and dexamethasone Elo RD Effectiveness will be measured by the depth of response ie whether or not minimal residual disease MRD negative status is achieved The rate of MRD negativity from this study will be compared to historical control data from the Total Therapy 4 trial which used continuous VRD maintenance therapy after stem cell transplants
Detailed Description:
None
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