Selinexor Treatment of Refractory Myeloma (STORM)
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|ClinicalTrials.gov Identifier: NCT02336815|
Recruitment Status : Recruiting
First Posted : January 13, 2015
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Selinexor Drug: Dexamethasone||Phase 2|
This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd), both dosed twice weekly in each four-week cycle, in patients with MM previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab and refractory to prior treatment with glucocorticoids, an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and daratumumab.
This study consists of two parts:
- Part 1 enrolled patients with both quad-refractory MM and penta-refractory MM.
- Part 2 will enroll patients with penta-refractory MM only.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-‑Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||October 2019|
U.S. FDA Resources
Experimental: Selinexor & Dexamethasone
Selinexor 80 mg (45 mg/m2 BSA) plus low-dose Dexamethasone (20 mg), both twice weekly by mouth
Fixed oral dose of 80 mg twice weekly (e.g., Monday and Wednesday or Tuesday and Thursday, etc.)
Other Name: KPT-330Drug: Dexamethasone
20 mg will be given with each dose of Selinexor.
- Overall Response Rate [ Time Frame: 5-7 months ]Achievement of sCR, CR, VGPR, or PR for the overall evaluable population with supportive data provided by DOR (duration of response).
- Duration of Response [ Time Frame: 5-7 months ]The duration of time measured from when measurement criteria for response were first met until the date of first recurrence, PD or death)
- Clinical Benefit Rate [ Time Frame: 6 months ]Clinical Benefit Rate (CBR = sCR + CR + PR + Minor Response [MR]), and duration of CBR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336815
|Contact: Michael Kauffman, MD, PhDemail@example.com|
|Contact: Sharon Shacham, PhDfirstname.lastname@example.org|
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|Study Director:||Michael Kauffman, MD, Ph.D||Karyopharm Therapeutics Inc|