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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 is a Phase 3 study that has completed, run by Karyopharm Therapeutics. The registered enrollment target is 402 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03110562
The ClinicalTrials.gov registry entry for NCT03110562 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 402 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Selinexor is the first listed.
NCT03110562 reports 0 study locations.
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.
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