drugset / Trial / NCT06046287

Daratumumab for Polyneuropathy Associated With MGUS

NCT06046287 ↗

NaSingle-groupOpen-labelSupportive care

Summary

The goal of this clinical trial is to learn about daratumumab and hyaluronidase-fihj in patients with monoclonal gammopathy of undetermined significant (MGUS) who have been diagnosed with peripheral neuropathy suspected to be cause by paraproteinemia. The main question\[s\] it aims to answer are: • how well does this medication help improve MGUS associated peripheral neuropathy Participants will be asked be asked to get some testing done prior to starting the trial in order for us to assess your nerve damage or peripheral neuropathy. This will include blood tests, a complete neurologic examination, surveys and tests called electromyogram and nerve conduction studies. Participants that qualify for the trial will take DARZALEX FASPRO® once a week for two months, followed by every other week from months 3 to month 6.

Timeline

Start
2025-09-26
Primary completion
2025-09-26
Completion
2025-09-26

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab and hyaluronidase-fihj Unknown 1800 mg Subcutaneous