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NCT04396496 · ClinicalTrials.gov registry record · Phase 2
Treatment of POEMS Syndrome With Daratumumab
A Phase 2 study of POEMS Syndrome, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT04396496: Completed Phase 2 study of POEMS Syndrome, sponsored by University of Arkansas.
NCT04396496 is a Phase 2 study of POEMS Syndrome that has completed, run by University of Arkansas. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04396496, a Phase 2 study of POEMS Syndrome, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial investigates the use of Daratumumab (DARA), an antibody directed at the human cluster of differentiation 38 (CD38) molecule, for the treatment of patients with Polyneuropathy, Organomegaly, Endocrinopathy, m Protein Component, Skin Changes (POEMS) syndrome. This trial will enroll ten subjects, who will complete 12 four-week cycles of DARA, in combination with the immunomodulatory drug (IMiD) lenalidomide. Objectives of this study include improvement in neuropathy and performance status, as well as improvement in laboratory values and survival.
Primary Outcome
There is a one-point improvement in ECOG performance score; and/or ≥ 50% reduction in ONLS score at Day 360.
Conditions Studied
Interventions
- DRUG Daratumumab Injection
Study Locations (1)
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2023-10-16 |
| Phase | Phase 2 |
What the finished NCT04396496 record still lists
NCT04396496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with POEMS Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab Injection is the first listed.
NCT04396496 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT04396496 about?
NCT04396496 is a clinical study titled "Treatment of POEMS Syndrome With Daratumumab". This trial investigates the use of Daratumumab (DARA), an antibody directed at the human cluster of differentiation 38 (CD38) molecule, for the treatment of patients with Polyneuropathy, Organomegaly, Endocrinopathy, m Protein Component, Skin Changes (POEMS) syndrome. This trial will enroll ten subj...
What is the current status of trial NCT04396496?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2020-09-22. Estimated completion is 2023-10-16.
What conditions does trial NCT04396496 study?
This clinical trial studies the following conditions: POEMS Syndrome.
What interventions are being tested in trial NCT04396496?
The interventions under investigation include: Daratumumab Injection (DRUG).
Who is sponsoring clinical trial NCT04396496?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04396496 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04396496's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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