Daratumumab for Polyneuropathy Associated With MGUS

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06046287
Phase
PHASE2
Status
Withdrawn

Conditions

  • Monoclonal Gammopathy of Undetermined Significance
  • Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab and hyaluronidase-fihj — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 26, 2025
Status verified
Sep 2025
Primary completion
Sep 26, 2025
Completion
Sep 26, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Daratumumab and hyaluronidase-fihj

Primary Outcome Measure

ISS score change [ Time Frame: 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C.District of Columbia20007-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-

Find similar trials in Washington D.C., DC

By research site
Lombardi Comprehensive Cancer Center, Georgetown University· Washington D.C., DCJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJ

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