NCT06046287

Daratumumab for Polyneuropathy Associated With MGUS

Phase IIa Study to Evaluate Daratumumab for Polyneuropathy Associated With MGUS

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Neuropathy
• Monoclonal Gammopathy of Undetermined Significance

Interventions

Type	Name	Description
DRUG	Daratumumab and hyaluronidase-fihj	subucatneous, fixed dose 1800mg combination drug product containing rHuPH20 drug substance (2000 U/mL) and daratumumab drug substance (120 mg/mL) will be administered weekly for the first 8 weeks, and then every 2 weeks from week 9 to week 24.

Timeline

• Start date: 2025-09-26
• Primary completion: 2025-09-26
• Completion: 2025-09-26
• First posted: 2023-09-21
• Last updated: 2025-10-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study