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NCT03110562 · ClinicalTrials.gov registry record · Phase 3
Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
A Phase 3 study, sponsored by Karyopharm Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 402
- Enrollment target
NCT03110562: Completed Phase 3 study, sponsored by Karyopharm Therapeutics.
NCT03110562 is a Phase 3 study that has completed, run by Karyopharm Therapeutics. The registered enrollment target is 402 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03110562, a Phase 3 study, has completed, sponsored by Karyopharm Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 402 participants
- Enrollment target
Study Summary
This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.
Primary Outcome
PFS was defined as time from date of randomization until the first date of IRC-confirmed PD, per International Myeloma Working Group (IMWG) response criteria, or death due to any cause, whichever occurs first. PD included increase of 25% from lowest confirmed response value in 1 or more of the following criteria: a) serum M-protein with absolute increase of \>= 0.5 gram per deciliter (g/dL); b) serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; c) urine M-protein (absol
Interventions
- DRUG Selinexor
- DRUG Dexamethasone
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2022-05-12 |
| Phase | Phase 3 |
What the finished NCT03110562 record still lists
NCT03110562 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Selinexor is the first listed.
NCT03110562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03110562 about?
NCT03110562 is a clinical study titled "Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma". This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethas...
What is the current status of trial NCT03110562?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 402 participants. The study started on 2017-05-24. Estimated completion is 2022-05-12.
What interventions are being tested in trial NCT03110562?
The interventions under investigation include: Selinexor (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT03110562?
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 NCT03110562's enrollment target sits among peer trials
402 919th of 2000 higher than 1,080 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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