What side effects are associated with this type of intervention?

Daratumumab, a monoclonal antibody targeting CD38, is associated with several side effects. Commonly reported adverse effects include higher rates of infection, particularly respiratory infections and pneumonia. Severe lymphocytopenia, which can lead to opportunistic infections such as Epstein-Barr virus or CMV reactivation and fungal meningitis, is also noted. Other side effects may include infusion-related reactions, fatigue, nausea, and back pain. Hyaluronidase-fihj, used to facilitate subcutaneous administration, generally has a favorable safety profile but can cause mild local reactions at the injection site.

What prior FDA approvals exist?

Daratumumab (DARZALEX FASPRO®) is an anti-CD38 monoclonal antibody approved by the FDA for the treatment of multiple myeloma, a condition related to monoclonal gammopathy. It targets CD38 on plasma cells, leading to their destruction. Similar treatments include Isatuximab, another anti-CD38 monoclonal antibody, and Elotuzumab, which targets SLAMF7 on myeloma cells. These drugs are often used in combination with agents like lenalidomide, dexamethasone, and bortezomib. Hyaluronidase-fihj is used to facilitate subcutaneous administration, improving delivery and patient comfort.

What other types of research exist?

Promising alternatives to DARZALEX FASPRO® for Monoclonal Gammopathy patients include Isatuximab, which also targets CD38 on plasma cells, and Elotuzumab, which targets SLAMF7 on myeloma cells. Both have shown efficacy in multiple myeloma and could be considered for MGUS-related conditions.

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Monoclonal Antibodies

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

Q: What is the mechanism of action of this treatment?

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9,12 months

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

0 / 13Eligibility criteria met

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.