DARZALEX FASPRO® for Peripheral Neuropathy

(Dara-MGUS Trial)

No longer recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, DARZALEX FASPRO® (daratumumab), to determine its effectiveness for people with peripheral neuropathy (nerve damage) linked to MGUS. The main goal is to see if this treatment can improve symptoms such as pain or difficulty moving. It suits those diagnosed with MGUS and experiencing disability due to peripheral neuropathy. Participants will take the medication weekly for two months, then every other week for the next four months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the combination of daratumumab and hyaluronidase-fihj, known as DARZALEX FASPRO®, is generally well-tolerated. Earlier studies identified the most common side effects as tiredness, nausea, diarrhea, and headaches. Some participants experienced mild reactions at the injection site, with only a few encountering more serious symptoms.

Other side effects, such as colds and infusion-related reactions, have been reported but were uncommon. While these side effects can occur, the treatment's approval for other uses suggests it is generally safe.

Participants should consider these findings when deciding whether to join a clinical trial. This information helps clarify what to expect regarding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peripheral neuropathy?

Unlike the standard treatments for peripheral neuropathy, which typically focus on symptom management through medications like pain relievers and anticonvulsants, DARZALEX FASPRO® offers an innovative approach by using daratumumab. Daratumumab is a monoclonal antibody that targets CD38, a protein highly expressed on certain immune cells. This unique mechanism may help modulate immune responses, potentially offering relief not just from symptoms but also addressing underlying causes of neuropathy. Researchers are excited because this could lead to more effective and long-lasting results compared to current options.

What evidence suggests that DARZALEX FASPRO® might be an effective treatment for peripheral neuropathy?

Research has shown that the treatment DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), which participants in this trial will receive, yields promising results for conditions related to MGUS, a blood disorder. In earlier studies, this treatment helped many patients, with 64.4% showing overall improvement and 30.5% experiencing a very good partial improvement. These results indicate that many patients notice significant benefits. Although most research has focused on multiple myeloma, these findings offer hope that it might also help with nerve problems linked to MGUS. The treatment targets and reduces harmful proteins in the blood, potentially easing symptoms of nerve damage. ^{1 2 5 6 7}

Who Is on the Research Team?

Kimberley Doucette, MD

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen, LP

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. darzalexhcp.com darzalexhcp.com/

DARZALEX® (daratumumab) & DARZALEX FASPRO ... You can see from the results presented that more patients achieved a complete response or better with DRd by 18 months vs Rd alone. Forty-nine point eight ...

2. jnj.com jnj.com/media-center/press-releases/darzalex-faspro-daratumumab-and-hyaluronidase-fihj-based-regimen-shows-95-percent-progression-free-survival-at-four-years-in-transplant-eligible-newly-diagnosed-patients-with-multiple-myeloma-who-achieved-sustained-mrd-negativity

DARZALEX FASPRO® (daratumumab and hyaluronidase ... Data from Phase 3 CEPHEUS study show 60 percent overall MRD negativity (10−5) and improved PFS with DARZALEX FASPRO® in transplant-ineligible ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06046287

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)

4. jnjmedicalconnect.com jnjmedicalconnect.com/products/darzalex-faspro/medical-content/use-of-darzalex-darzalex-faspro-in-combination-with-ixazomib-in-multiple-myeloma

DARZALEX FASPRO® (daratumumab and hyaluronidase- ... In all response-evaluable patients, the very good partial response (VGPR) or better rate was 30.5% and the overall response rate (ORR) was 64.4% ...

5. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/darzalex

Darzalex | European Medicines Agency (EMA) Around 29% of the patients receiving Darzalex at the recommended dose (31 out of 106 patients) responded to treatment in the first study and 36% (15 out of 42 ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761145s025lbl.pdf

Reference ID: 5421808 - accessdata.fda.gov The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, ...

7. jnjmedicalconnect.com jnjmedicalconnect.com/products/darzalex-faspro/isi-english

DARZALEX FASPRO - Important Safety Information (English) The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, ...