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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9,12 months

Awards & highlights

Dara-MGUS Trial Summary

This trial will investigate if DARZALEX FASPRO® helps improve MGUS-associated peripheral neuropathy. Participants will get testing and take a medication for 6 months to see if it helps.

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.Check my eligibility

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.See study design

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.

Dara-MGUS Trial 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.

Dara-MGUS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ISS score change

Secondary outcome measures

Change in anti-MAG titers (serology)

Change in health-related quality of life

Change in immunofixation (IFE)

+6 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134

60%

Thrombocytopenia

50%

Peripheral sensory neuropathy

47%

Peripheral Sensory Neuropathy

36%

Upper respiratory tract infection

36%

Diarrhoea

29%

Cough

28%

Anaemia

23%

Fatigue

23%

Upper Respiratory Tract Infection

23%

Constipation

21%

Back pain

20%

Arthralgia

20%

Oedema peripheral

19%

Neutropenia

19%

Dyspnoea

18%

Insomnia

17%

Pyrexia

16%

Oedema Peripheral

15%

Nausea

14%

Lymphopenia

14%

Pain in extremity

14%

Nasopharyngitis

14%

Bronchitis

14%

Neuralgia

13%

Back Pain

13%

Dizziness

12%

Decreased appetite

12%

Vomiting

12%

Headache

12%

Hypertension

11%

Conjunctivitis

11%

Asthenia

11%

Pneumonia

11%

Hypokalaemia

10%

Muscle spasms

10%

Musculoskeletal chest pain

Urinary tract infection

Leukopenia

Bone pain

Decreased Appetite

Hyperglycaemia

Pain in Extremity

Bronchospasm

Weight decreased

Muscle Spasms

Abdominal pain upper

Alanine aminotransferase increased

Hypophosphataemia

Herpes zoster

Influenza

Hypocalcaemia

Alanine Aminotransferase Increased

Rash

Musculoskeletal Chest Pain

Myalgia

Aspartate aminotransferase increased

Nasal congestion

Abdominal pain

Bone Pain

Hypotension

Abdominal Pain Upper

Weight Decreased

Chills

Productive cough

Throat irritation

Herpes Zoster

Oedema

Paraesthesia

Epistaxis

Dyspepsia

Atrial fibrillation

Acute kidney injury

Sepsis

Atrial Fibrillation

Acute myocardial infarction

Pneumonia cytomegaloviral

Pleural effusion

Rib fracture

Lower Respiratory Tract Infection

Pulmonary sepsis

Pulmonary Sepsis

Hypercalcaemia

Pneumonia Cytomegaloviral

Cardiac failure congestive

Acute coronary syndrome

Lower respiratory tract infection

Hip fracture

Angina unstable

Cerebrovascular accident

Ischaemic stroke

Bronchitis chronic

Humerus fracture

Respiratory failure

Gastroenteritis

Pathological fracture

Femur fracture

Febrile neutropenia

Squamous cell carcinoma of skin

Ischaemic Stroke

Respiratory Failure

Pathological Fracture

Febrile Neutropenia

Cardiac Failure Congestive

Bronchopneumonia

Femur Fracture

Humerus Fracture

Acute Kidney Injury

Pleural Effusion

100%

80%

60%

40%

20%

Study treatment Arm

Daratumumab + Bortezomib and Dexamethasone (DVd)

Bortezomib + Dexamethasone (Vd)

Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Dara-MGUS Trial Design

1Treatment groups

Experimental Treatment

Group I: Daratumumab and hyaluronidase-fihjExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,482 Total Patients Enrolled

Janssen, LPIndustry Sponsor

160 Previous Clinical Trials

307,970 Total Patients Enrolled

Kimberley Doucette, MDPrincipal InvestigatorGeorgetown University

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies to join this study?

"According to the information available on clinicaltrials.gov, this study has ceased recruitment of participants as its most recent edit was made on September 14th 2023. Nonetheless, there are a plethora of other medical trials in need of candidates at present."

Answered by AI

Is the combination of Daratumumab and hyaluronidase-fihj safe for individuals to use?

"Taking into account its Phase 2 status, the safety of Daratumumab and hyaluronidase-fihj was evaluated as a 2 on Power's scale. Currently, there is limited data indicating efficacy but enough to deem it safe for clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daratumumab for Polyneuropathy Associated With MGUS

2024. "Daratumumab for Polyneuropathy Associated With MGUS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046287.

All > Neuropathy > Peripheral Neuropathy