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Peripheral NeuropathyPhase 2Dara-MGUSNCT06046287

Daratumumab for Polyneuropathy Associated With MGUS

A Phase 2 study testing Daratumumab and hyaluronidase-fihj in people with Peripheral Neuropathy and Monoclonal Gammopathy of Undetermined Significance, run by Georgetown University at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Daratumumab and hyaluronidase-fihj
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
26 Sep 2025to 26 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
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  • Serum monoclonal protein <30g/L
  • Clonal bone marrow lymphoplasmacytic/plasma cells <10%
  • Absence of end-organ damage related to the plasma cell dyscrasia*
  • Serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL)
  • Renal insufficiency: creatinine clearance <40 mL per minute or serum creatinine >177mol/L (>2mg/dL)
  • Anemia: hemoglobin value of >20g/L below the lowest limit of normal, or a hemoglobin value <100g/L
  • Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or PET/CT. If bone marrow has <10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 3 (see appendix)
  • Adequate bone marrow function:
  • Total WBC count ≥ 1,500/mm3, ANC ≥ 1,000/mm3
  • Hemoglobin (Hb) ≥ 8.0 g/dL,
  • Platelet count ≥ 75,000/mm3.
  • Adequate liver function:
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN)
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 is permissible if due to disease.
  • Bilirubin ≤ 2 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin for which > 2 x ULN is an acceptable limit)
  • Adequate renal function: creatinine clearance ≥ 20mL/min.
  • Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry.
  • Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for at least 3 months after the last dose of study drug.

Who cannot join

  • Documented active multiple myeloma, smoldering myeloma, Waldenstroms macroglobulinemia, non-IgM MGUS, plasma cell leukemia or systemic amyloid light chain amyloidosis
  • Concomitant disorder felt to possibly be related to the etiology of the peripheral neuropathy: diabetes, vitamin deficiency, chronic alcohol consumption, drugs, HCV infection.**
  • Prior or current exposure to any of the following:
  • To daratumumab and Hyaluronidase-fhj or other anti-CD-38 therapies (unless a re-treatment study)
  • Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.
  • Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is < 50% of predicted normal.
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  • Moderate or severe persistent asthma within the past 2 years (see Appendix section 1), or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.
  • Participant is:
  • Known history of human immunodeficiency virus (HIV)
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (i.e., subjects who are HBsAg negative with antibodies to total hepatitis B core antigen [anti-HBc] with or without the presence of hepatitis B surface antibody [anti-HBs]) must be screed using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of HBV vaccination, do not need to be testing for HBV DNA by PCR.
  • Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as a viremia at least 12 weeks after completion of antiviral therapy).
  • Patients who have implanted deep brain stimulators and vagal nerve stimulators.
  • Clinically significant cardiac disease, including:
  • Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV) [refer to Appendix section 3]
  • Uncontrolled cardiac arrhythmia
  • Patients with external pacing wires or intracardiac catheters
  • If patient is unable to sign informed consent due to any serious medical condition, laboratory abnormality or psychiatric illness
  • If patient is pregnant or breastfeeding, a prisoner, or not yet an adult
  • Any life-threatening illness, medical condition, concomitant active cancer, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Phase IIa Study to Evaluate Daratumumab for Polyneuropathy Associated With MGUS

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.

Being tested
Daratumumab and hyaluronidase-fihj
Medical subject headings
Peripheral Nervous System Diseases, Monoclonal Gammopathy of Undetermined Significance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daratumumab and hyaluronidase-fihjDrug

    Also called Darzalex Faspro

    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 groups in NCT06046287
Study groupRoleWhat they receive
Daratumumab and hyaluronidase-fihjExperimentalNot described
Receives: Drug: Daratumumab and hyaluronidase-fihj

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ISS score change

    changes from baseline to 12 months in functional assessments ISS score

    Measured: 12 months

Secondary outcomes (9)

  1. Functional Assessment change

    absolute change from baseline in functional assessments using clinical examinations (sensory, reflexive)

    Measured: 3, 6, 9,12 months

  2. Change in nerve conduction studies (NCS)

    absolute change from baseline in functional assessments using nerve conduction studies (NCS)

    Measured: 3, 6, 9, 12 months

  3. Electromyography (EMG) changes

    change from baseline in electromyography (EMG) measured at 12 months

    Measured: 12 months

  4. Inflammatory Neuropathy Cause and Treatment (INCAT) changes

    Absolute change from baseline in clinician-reported functional measures using the modified Rankin Score, Inflammatory Neuropathy Cause and Treatment (INCAT)

    Measured: 3, 6, 9, 12 months

  5. Change in health-related quality of life

    Absolute change from baseline in patient reported health-related quality of life (HRQOL) outcomes, assessed by the 36-item Short Form Health Survey (SF-36) measure.

    Measured: 3, 6, 9, and 12 months

  6. Change in immunofixation (IFE)

    Absolute change from baseline in immunofixation (IFE),

    Measured: 3, 6, 9, and 12 months

  7. Change in immunoglobulin concentration

    Absolute change from baseline in immunoglobulin concentration

    Measured: 3, 6, 9, and 12 months

  8. Change in serum protein electrophoresis (SPEP)

    Absolute change from baseline in serum protein electrophoresis (SPEP)

    Measured: 3, 6, 9, and 12 months

  9. Change in anti-MAG titers (serology)

    Absolute change from baseline in anti-MAG titers (serology)

    Measured: 3, 6, 9, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start26 Sep 2025
  3. Primary completion26 Sep 2025
  4. Study completion26 Sep 2025

Why it stopped: Lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06046287
Sponsor's protocol ID
STUDY00005648
Acronym
Dara-MGUS
Status last verified
Sep 2025
First submitted
14 Sep 2023
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab and hyaluronidase-fihj in people with Peripheral Neuropathy and Monoclonal Gammopathy of Undetermined Significance, run by Georgetown University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ISS score change (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06046287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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