Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05170789
Status:
WITHDRAWN
Last Update Posted:
2022-05-04
First Post:
2021-10-11
Brief Title:
Elotuzumab Selinexor and Dexamethasone for Relapsed Refractory Multiple Myeloma
Sponsor:
Tulane University School of Medicine
Organization:
Tulane University
Study Overview
Official Title:
A Phase II Single-Arm Study of Elotuzumab Selinexor and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study collaborator -Karyopharm- is not doing Myeloma studies funding so they let the study investigators know they are not funding the study anymore
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESdRRMM
Brief Summary:
The food and drug administration FDA has approved the use of Selinexor an oral first-in class exportin 1 XPO1 inhibitor in combination with low-dose dexamethasone in patients with triple-refractory disease refractory to proteasome inhibitors PI immunomodulatory imid agents IMiD and anti-Cluster of Differentiation 38 CD38 monoclonal antibodies mAb or relapsed refractory multiple myeloma RRMM SLAMF7 human Signaling Lymphocyte Activation Molecule Family 7 is a receptor that is present on immune cells NK Natural Killer cells and plasma cells Elotuzumab a mAb directed against the extracellular domain of SLAMF7 is used in combination with an IMiD and dexamethasone to treat RRMM In this clinical trial the investigators are proposing the addition of Elotuzumab to Selinexor and low-dose dexamethasone ESd in RRMM previously treated with one or a combination of PIs IMiDs and anti-CD38 mAb
Detailed Description:
Selinexor reversibly inhibits nuclear export of tumor suppressor proteins TSPs resulting in a pro-apoptotic effect In addition previous studies found that selinexor alone or in combination with anti-PD-L1 Programmed Death-Ligand 1 antibody significantly increased the frequency of natural killer cells on immunophenotypic analysis of splenocytes by flow cytometry Elotuzumab activates NK cells through SLAMF7 and results in NK cell-mediated antibody dependent cellular toxicity ADCC This clinical trial is designed on the premise that these two medications could have a synergistic effect resulting in a better clinical response in the treatment of RRMM
The investigators will evaluate the ORR overall response rate CR Complete Response VGPR Very Good Partial Response PR Partial Response rates and the duration of response Special consideration will be given to multiple myeloma patients with t1114 q13q32 given it is the most common chromosome translocation in multiple myeloma with early reported activity of Selinexor on BCR Breakpoint Cluster Region Protein inhibition Finally the investigators will evaluate the correlation between NK function and the response rate to possibly develop a predictive model of response rate to the combination based on NK activity measurements pre during and post treatment Quantitative testing includes the number of NK CD3- CD5616 cells NK subsets CD56bright to CD56dim ratio and qualitative testing includes chromium release assay using 51Cr for cytotoxicity testing In addition the investigators will follow the response of African American patients to this regimen in an ancillary ad hoc study given the under representation in the STORM Selinexor Treatment of Refractory Myeloma trial
The investigators will evaluate the ORR overall response rate CR Complete Response VGPR Very Good Partial Response PR Partial Response rates and the duration of response Special consideration will be given to multiple myeloma patients with t1114 q13q32 given it is the most common chromosome translocation in multiple myeloma with early reported activity of Selinexor on BCR Breakpoint Cluster Region Protein inhibition Finally the investigators will evaluate the correlation between NK function and the response rate to possibly develop a predictive model of response rate to the combination based on NK activity measurements pre during and post treatment Quantitative testing includes the number of NK CD3- CD5616 cells NK subsets CD56bright to CD56dim ratio and qualitative testing includes chromium release assay using 51Cr for cytotoxicity testing In addition the investigators will follow the response of African American patients to this regimen in an ancillary ad hoc study given the under representation in the STORM Selinexor Treatment of Refractory Myeloma trial
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?:
True
Is an FDA AA801 Violation?:
None