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Monoclonal Antibodies

DARZALEX FASPRO® for Peripheral Neuropathy (Dara-MGUS Trial)

Phase 2
Recruiting
Led By Kimberley Doucette, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of chronic demyelinating neuropathy according to the European Federation of Neurological Societies/Peripheral Nerve Society guidelines for chronic inflammatory demyelinating polyneuropathy with concurrent diagnosis of monoclonal gammopathy of undetermined significance (MGUS) with an IgM monoclonal peak
Ataxia score ≥2 and/or visual analog pain scale (VAS) >4
Must not have
Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal
Clinically significant cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9,12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an injectable medication called DARZALEX FASPRO® in patients with MGUS who have nerve damage. The goal is to see if this treatment can improve their nerve-related symptoms. The medication works by helping the immune system target abnormal cells and improving absorption of the drug.

Who is the study for?
Adults with MGUS-related peripheral neuropathy, who have certain levels of nerve damage and disability, can join. They must have good bone marrow and liver function, use effective birth control, and not be pregnant or breastfeeding. People with prior daratumumab exposure, HIV, hepatitis B/C, other cancers like multiple myeloma or serious medical conditions that could risk safety are excluded.
What is being tested?
The trial tests DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for improving nerve damage in MGUS patients. Participants will undergo initial testing to assess their condition before receiving the medication weekly for two months then every other week until month six.
What are the potential side effects?
Potential side effects may include reactions at the injection site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, diarrhea as well as possible effects on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic demyelinating neuropathy and MGUS with an IgM peak.
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I have trouble with coordination or my pain level is above moderate.
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I am not able to become pregnant or I have a negative pregnancy test before starting the study.
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I have nerve damage related to high anti-MAG levels.
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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung function is less than half of what is expected for someone my age and size.
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I have a serious heart condition.
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I do not have any severe illnesses that could risk my safety in the study.
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I have been treated with daratumumab or other anti-CD38 therapies.
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I am not pregnant, breastfeeding, imprisoned, or under the legal adult age.
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I have been diagnosed with HIV.
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I have a diagnosis of a specific blood or bone marrow cancer.
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I have had severe or uncontrolled asthma in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9,12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9,12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ISS score change
Secondary study objectives
Change in anti-MAG titers (serology)
Change in health-related quality of life
Change in immunofixation (IFE)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Daratumumab and hyaluronidase-fihjExperimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Daratumumab, a monoclonal antibody targeting CD38 on plasma cells, induces their destruction through mechanisms such as complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis. Hyaluronidase-fihj facilitates subcutaneous administration by breaking down hyaluronic acid, enhancing drug absorption and dispersion. This combination is crucial for Monoclonal Gammopathy patients as it improves treatment efficacy and convenience, potentially leading to better patient outcomes and adherence.

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
347 Previous Clinical Trials
137,096 Total Patients Enrolled
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
310,365 Total Patients Enrolled
Kimberley Doucette, MDPrincipal InvestigatorGeorgetown University
1 Previous Clinical Trials
24 Total Patients Enrolled
~13 spots leftby Dec 2026