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NCT04925193 · ClinicalTrials.gov registry record · Phase 2
Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma
A Phase 2 study of Multiple Myeloma in Relapse, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04925193: Active Phase 2 study of Multiple Myeloma in Relapse, sponsored by University of Colorado, Denver.
NCT04925193 is a Phase 2 study of Multiple Myeloma in Relapse that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 18 participants, below the 50-participant average among 12 other Multiple Myeloma in Relapse trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04925193, a Phase 2 study of Multiple Myeloma in Relapse, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM). This trial will seek to evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician's choice and compared prospectively to ex vivo drug sensitivity testing results. Participants will be enrolled and assigned into one of three treatment selection groups. The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. Selection groups are as follows: Group 1: Selinexor + pomalidomide + dexamethasone (SPd) Group 2: Selinexor + daratumumab + dexamethasone (SDd) Group 3: Selinexor + carfilzomib + dexamethasone (SKd)
Primary Outcome
To evaluate the overall response rate achieved with physician's choice selinexor-based combination therapy as measured by International Myeloma Working Group criteria (based on Kumar et al 2016).
Conditions Studied
Interventions
- DRUG Selinexor
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG Pomalidomide
- DRUG Carfilzomib
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What the registry record for NCT04925193 still lists
NCT04925193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 50-participant average among 12 other Multiple Myeloma in Relapse trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Multiple Myeloma in Relapse appearing as the primary indexed condition, and to 5 interventions - of which Selinexor is the first listed.
NCT04925193 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04925193 about?
NCT04925193 is a clinical study titled "Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma". Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM). This trial will seek to evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician's choice and...
What is the current status of trial NCT04925193?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2021-11-18. Estimated completion is 2026-11.
What conditions does trial NCT04925193 study?
This clinical trial studies the following conditions: Multiple Myeloma in Relapse.
What interventions are being tested in trial NCT04925193?
The interventions under investigation include: Selinexor (DRUG), Dexamethasone (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT04925193?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04925193 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04925193's enrollment target sits among peer trials
18 11th of 12 higher than 1 of 12 other Multiple Myeloma in Relapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma in Relapse 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.
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