Trial · NCT04396496
Treatment of POEMS Syndrome With Daratumumab
NCT04396496, Phase 2, Completed, University of Arkansas; results first posted 2023-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of POEMS Syndrome With Daratumumab. Trials, record NCT04396496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04396496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of POEMS Syndrome With Daratumumab
- NCT number
- NCT04396496
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- University of Arkansas
- Conditions
- POEMS Syndrome
- Interventions
- Daratumumab Injection
- First posted
- 2020-05-20
- Last updated
- 2023-11-13
- Results first posted
- 2023-11-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Success | 360 days | There is a one-point improvement in ECOG performance score; and/or ≥ 50% reduction in ONLS score at Day 360. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Success | 360 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Success | Daratumumab Injection | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daratumumab Injection | 2 | |
| Overall Study | COMPLETED | Daratumumab Injection | 2 | |
| Overall Study | NOT COMPLETED | Daratumumab Injection | 0 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Daratumumab Injection | 1 | 2 | 1 |
| other | Constipation | Gastrointestinal disorders | Daratumumab Injection | 2 | 2 | 2 |
| other | Fever | General disorders | Daratumumab Injection | 2 | 2 | 2 |
| other | Fatigue | General disorders | Daratumumab Injection | 1 | 2 | 1 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Daratumumab Injection | 2 | 2 | 2 |
| other | Neutrophil count decreased | Investigations | Daratumumab Injection | 1 | 2 | 1 |
| other | White blood cell decreased | Investigations | Daratumumab Injection | 1 | 2 | 1 |
| other | Headache | Nervous system disorders | Daratumumab Injection | 1 | 2 | 1 |
| other | Laryngospasm | Respiratory, thoracic and mediastinal disorders | Daratumumab Injection | 1 | 2 | 1 |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Daratumumab Injection | 1 | 2 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daratumumab Injection | 0 | 2 |
| Total, other adverse events | Daratumumab Injection | 2 | 2 |
| Total, serious adverse events | Daratumumab Injection | 1 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04396496
GET https://conductscience.org/api/trials/v1/NCT04396496/events?page=2