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NCT02336815 · ClinicalTrials.gov registry record · Phase 2
Selinexor Treatment of Refractory Myeloma
A Phase 2 study, sponsored by Karyopharm Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
NCT02336815: Completed Phase 2 study, sponsored by Karyopharm Therapeutics.
NCT02336815 is a Phase 2 study that has completed, run by Karyopharm Therapeutics. The registered enrollment target is 202 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02336815, a Phase 2 study, has completed, sponsored by Karyopharm Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
Study Summary
This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).
Primary Outcome
IRC assessed ORR per 2016 IMWG criteria: Percentage of participants who experienced Partial response (PR): greater than or equal to (\>=) 50 percent (%) reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>= 90% or to lesser than (\<) 200 mg per 24 hours; Very good partial response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours; Compl
Interventions
- DRUG Selinexor
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2015-05-26 |
| Est. Completion | 2019-07-26 |
| Phase | Phase 2 |
What the finished NCT02336815 record still lists
NCT02336815 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 2 interventions - of which Selinexor is the first listed.
NCT02336815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02336815 about?
NCT02336815 is a clinical study titled "Selinexor Treatment of Refractory Myeloma". This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).
What is the current status of trial NCT02336815?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2015-05-26. Estimated completion is 2019-07-26.
What interventions are being tested in trial NCT02336815?
The interventions under investigation include: Selinexor (DRUG), Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT02336815?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02336815's enrollment target sits among peer trials
202 301st of 2000 higher than 1,699 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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