WithdrawnPhase 2

Daratumumab for Polyneuropathy Associated With MGUS

Stopped: Lack of accrual

United States0Started 2025-09-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years at the time of informed consent
✓. A diagnosis of chronic demyelinating neuropathy according to the European Federation of Neurological Societies/Peripheral Nerve Society guidelines for chronic inflammatory demyelinating polyneuropathy (as determined by neurologist) with concurrent diagnosis of monoclonal gammopathy of undetermined significance (MGUS) with an IgM monoclonal peak (see appendix 8)
✓. Peripheral neuropathy associated with anti-MAG \>7000 BTU, with EMG/NCS consistent with polyneuropathy.
✓. Patients will have to have disability associated with their peripheral neuropathy, with a baseline INCAT Sensory Score (ISS) score ≥4.
✓. They must have an ataxia score ≥2 (0 = normal, 1 = slight oscillations, 2 = marked oscillations, 3 = severe ataxia), and/or visual analog pain scale (VAS) \>4 (from 0 = no pain to 10 = maximal pain).
✓. Must meet MGUS diagnostic criteria as diagnosed using IMWG criteria using the following criteria (see section 1 appendix):
✓. Serum monoclonal protein \<30g/L
✓. Clonal bone marrow lymphoplasmacytic/plasma cells \<10%

Exclusion criteria

What they're measuring

ISS score change

Timeframe: 12 months

Trial details

NCT IDNCT06046287

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-26

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