Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 6:47 AM
Study NCT ID:
NCT02628704
Status:
WITHDRAWN
Last Update Posted:
2023-01-26
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Study Overview
Official Title:
Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Selinexor (KPT-330), Carfilzomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma Previously Treated With a Proteasome Inhibitor and an Immunomodulatory Drug
Status:
WITHDRAWN
Status Verified Date:
2023-01
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:
SCORE
Brief Summary:
Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma.
Detailed Description:
This is a Phase 2, two-arm, randomized, placebo-controlled, double-blind, multicenter study of relapsed/refractory multiple myeloma patients who have received at least two prior therapies, including a proteasome inhibitor and an IMiD.
Patients who meet all the eligibility criteria will be randomized to one of two blinded treatment arms:
* selinexor + carfilzomib + dexamethasone
* placebo + carfilzomib + dexamethasone
Patients who meet all the eligibility criteria will be randomized to one of two blinded treatment arms:
* selinexor + carfilzomib + dexamethasone
* placebo + carfilzomib + dexamethasone
Study Oversight
Has Oversight DMC:
True
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?: