DARZALEX FASPRO® for Peripheral Neuropathy

(Dara-MGUS Trial)

Recruiting at 1 trial location

Overseen By Ella Rutanen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Georgetown University

Must not be taking: Anti-CD-38 therapies

Disqualifiers: Multiple myeloma, Diabetes, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking medications for conditions like diabetes, vitamin deficiencies, or chronic alcohol consumption, you may be excluded from the trial.

Research Team

Kimberley Doucette, MD

Principal Investigator

Georgetown University

Eligibility Criteria

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.

Inclusion Criteria

I have chronic demyelinating neuropathy and MGUS with an IgM peak.

I have trouble with coordination or my pain level is above moderate.

My bone marrow and liver are working well.

Exclusion Criteria

My lung function is less than half of what is expected for someone my age and size.

I have a condition like diabetes or vitamin deficiency that might be causing my nerve pain.

I have a serious heart condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive DARZALEX FASPRO® once a week for two months, followed by every other week from months 3 to month 6

6 months

Weekly visits for 2 months, then bi-weekly visits for 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular assessments at 3, 6, 9, and 12 months

Treatment Details

Interventions

• Daratumumab

Trial Overview 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.

Participant Groups

Group I: Daratumumab and hyaluronidase-fihj Experimental Treatment 1 Intervention

Daratumumab is already approved in European Union, United States for the following indications:

Approved in European Union as Darzalex for:

• Relapsed and refractory multiple myeloma
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

Approved in United States as Darzalex for:

• Multiple myeloma in patients who have received at least three prior therapies
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
• Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Janssen, LP

Industry Sponsor

Trials

169

Recruited

329,000+

Founded

1953

Headquarters

Beerse, Belgium

Known For

Mental Health Therapies

Top Products

Imodium, Remicade, Invega, Procrit

Joaquin Duato

Janssen, LP

Chief Executive Officer since 2022

MBA from ESADE Business School

Biljana Naumovic

Janssen, LP

Chief Medical Officer since 2023

MD from Belgrade University Medical School