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Daratumumab for Polyneuropathy Associated With MGUS

NCT06046287 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-10-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Kimberley Doucette, MD · Georgetown University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2025-09-26
Completion
2025-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06046287 on ClinicalTrials.gov