Trial · NCT06046287
Daratumumab for Polyneuropathy Associated With MGUS
NCT06046287, Phase 2, Withdrawn, Georgetown University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Daratumumab for Polyneuropathy Associated With MGUS. Trials, record NCT06046287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06046287
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daratumumab for Polyneuropathy Associated With MGUS
- NCT number
- NCT06046287
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Georgetown University
- Conditions
- Peripheral Neuropathy, Monoclonal Gammopathy of Undetermined Significance
- Interventions
- Daratumumab and hyaluronidase-fihj
- First posted
- 2023-09-21
- Last updated
- 2025-10-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ISS score change | 12 months | changes from baseline to 12 months in functional assessments ISS score |
| Secondary | Functional Assessment change | 3, 6, 9,12 months | absolute change from baseline in functional assessments using clinical examinations (sensory, reflexive) |
| Secondary | Change in nerve conduction studies (NCS) | 3, 6, 9, 12 months | absolute change from baseline in functional assessments using nerve conduction studies (NCS) |
| Secondary | Electromyography (EMG) changes | 12 months | change from baseline in electromyography (EMG) measured at 12 months |
| Secondary | Inflammatory Neuropathy Cause and Treatment (INCAT) changes | 3, 6, 9, 12 months | Absolute change from baseline in clinician-reported functional measures using the modified Rankin Score, Inflammatory Neuropathy Cause and Treatment (INCAT) |
| Secondary | Change in health-related quality of life | 3, 6, 9, and 12 months | Absolute change from baseline in patient reported health-related quality of life (HRQOL) outcomes, assessed by the 36-item Short Form Health Survey (SF-36) measure. |
| Secondary | Change in immunofixation (IFE) | 3, 6, 9, and 12 months | Absolute change from baseline in immunofixation (IFE), |
| Secondary | Change in immunoglobulin concentration | 3, 6, 9, and 12 months | Absolute change from baseline in immunoglobulin concentration |
| Secondary | Change in serum protein electrophoresis (SPEP) | 3, 6, 9, and 12 months | Absolute change from baseline in serum protein electrophoresis (SPEP) |
| Secondary | Change in anti-MAG titers (serology) | 3, 6, 9, and 12 months | Absolute change from baseline in anti-MAG titers (serology) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06046287
GET https://conductscience.org/api/trials/v1/NCT06046287/registered