Home-Based Daratumumab for Multiple Myeloma

Overseen By Adam Binder, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Thomas Jefferson University

Must be taking: Daratumumab

Disqualifiers: Pregnancy, HIV, Hepatitis B, 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: 9

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering daratumumab, a cancer-fighting drug, for individuals with multiple myeloma, a type of blood cancer. The research examines administering this treatment at home instead of in a clinic, potentially reducing costs and easing the burden on patients. Daratumumab is combined with hyaluronidase to enhance its duration and effectiveness in the body. Individuals with multiple myeloma who already use daratumumab in their treatment plan may be suitable candidates, particularly if they live near Jefferson Home Infusion Services and are open to receiving treatment at home. As an Early Phase 1 trial, this research seeks to understand the treatment's effects in people, offering participants an opportunity to contribute to groundbreaking advancements in cancer care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must already be on a monthly daratumumab regimen to participate.

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

Research has shown that DARZALEX FASPRO®, a combination of daratumumab and hyaluronidase-fihj, is approved for treating multiple myeloma, indicating prior safety testing in humans. However, serious reactions, including some fatal ones, have been reported with treatments containing daratumumab, such as DARZALEX FASPRO®. In a large safety study involving 1,249 patients, some experienced side effects from these treatments.

While this combination is generally considered safe enough for approval in treating multiple myeloma, the current trial tests its use in a new setting—at home. Prospective participants should discuss these safety findings with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, which typically involve intravenous administration at a clinic, the combination of daratumumab and hyaluronidase-fihj offers a unique delivery method. This treatment is administered subcutaneously, allowing for some doses to be given at home. Researchers are excited about this because it could make treatment more convenient and accessible for patients, reducing the need for frequent visits to an infusion center. Additionally, the subcutaneous method is quicker, taking just 3-5 minutes, which could improve the overall patient experience.

What evidence suggests that home-based daratumumab is effective for multiple myeloma?

Research shows that Darzalex Faspro, a combination of daratumumab and hyaluronidase, effectively treats multiple myeloma, a type of blood cancer. Studies have found that more than half of the patients receiving this treatment had no detectable cancer cells for 24 months or more. Additionally, 95% of these patients did not experience cancer worsening over four years. Since 2015, Darzalex Faspro has been approved for use in treating multiple myeloma in various combinations, proving its effectiveness. This trial will evaluate the administration of Darzalex Faspro both in an infusion center and at home. The aim is to stop cancer cell growth, with hyaluronidase helping the drug remain in the body longer for better results. ^{1 2 6 7 8}

Who Is on the Research Team?

Adam R Binder, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

Adults over 18 with multiple myeloma, able to consent and follow study procedures. Must live within Jefferson Home Infusion Services range, speak English, and be on a monthly phase of daratumumab treatment. Women and men must use effective contraception. Participants need normal liver function tests, an ANC > 1,000, platelets > 50,000, and adequate kidney function.

Inclusion Criteria

Lives within the range of Jefferson Home Infusion Services

Women of reproductive potential must use highly effective contraception

I am willing to get shots of daratumumab.

Exclusion Criteria

I am taking daratumumab for a condition that is not multiple myeloma.

You have hepatitis C unless you have been successfully treated for it.

I do not have serious heart conditions or recent heart attacks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daratumumab and hyaluronidase-fihj subcutaneously over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles.

32 weeks

8 visits (4 in-person, 4 home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Daratumumab and Hyaluronidase-fihj

Trial Overview The trial is testing home administration of Darzalex Faspro (daratumumab and hyaluronidase) for multiple myeloma patients. It aims to see if receiving this treatment at home can reduce costs and the burden of care compared to standard cancer center visits.

How Is the Trial Designed?

Group I: Treatment (daratumumab and hyaluronidase-fihj) Experimental Treatment 4 Interventions

Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

Daratumumab and Hyaluronidase-fihj is already approved in European Union, United States for the following indications:

Approved in European Union as Darzalex for:

• Multiple myeloma
• AL amyloidosis

Approved in United States as Darzalex for:

• Multiple myeloma

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

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

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Daratumumab is a monoclonal antibody that effectively targets CD38 on multiple myeloma cells, leading to cell death through various mechanisms such as complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity.

It has shown a favorable safety profile and significant clinical activity as both a standalone treatment and in combination with lenalidomide for patients with relapsed multiple myeloma who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: monoclonal antibody therapy to treat multiple myeloma. Xia, C., Ribeiro, M., Scott, S., et al.[2018]

Daratumumab, a monoclonal antibody targeting CD38, has been approved in the USA for treating multiple myeloma in patients who have undergone at least three prior therapies, demonstrating its role as a treatment option for difficult-to-treat cases.

In a phase II trial, daratumumab monotherapy showed an overall response rate of about 30% in patients with relapsed or refractory multiple myeloma, indicating its efficacy in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: First Global Approval. McKeage, K.[2018]

Daratumumab, a monoclonal antibody targeting CD38, has shown significant efficacy as a monotherapy in relapsed/refractory multiple myeloma, achieving an overall response in about one-third of patients, with rapid and durable effects.

In combination with other treatments like bortezomib or lenalidomide, daratumumab significantly prolonged progression-free survival, although the overall survival benefit is still being evaluated, and it was generally well tolerated with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. Blair, HA.[2018]

Daratumumab received conditional marketing authorization in the EU for treating relapsed and refractory multiple myeloma, showing an overall response rate of 29.2% in heavily pre-treated patients, indicating its efficacy as a monotherapy.

The drug was later approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, demonstrating improved progression-free survival in patients who had received at least one prior therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma. Tzogani, K., Penninga, E., Schougaard Christiansen, ML., et al.[2020]

Daratumumab, an anti-CD38 monoclonal antibody, has significantly improved treatment outcomes for multiple myeloma (MM), showing enhanced progression-free survival and response rates in relapsed/refractory cases when combined with other therapies, as demonstrated in several key clinical trials.

In newly diagnosed patients, daratumumab has also shown an overall survival benefit when added to frontline treatment regimens, indicating its effectiveness in both early and advanced stages of MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab for the Treatment of Multiple Myeloma: A Review of Clinical Applicability and Operational Considerations. Arnall, JR., Maples, KT., Harvey, RD., et al.[2022]

In a phase 3 trial with 569 patients, the addition of daratumumab to lenalidomide and dexamethasone significantly improved progression-free survival, with only 18.5% of patients experiencing disease progression compared to 41.0% in the control group.

Daratumumab also resulted in a higher overall response rate (92.9% vs. 76.4%) and a greater percentage of patients achieving minimal residual disease status (22.4% vs. 4.6%), although it was associated with a higher incidence of neutropenia and infusion-related reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. Dimopoulos, MA., Oriol, A., Nahi, H., et al.[2022]

Citations

1. 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 ... More than half of patients who received the DARZALEX FASPRO®-based regimen achieved sustained MRD negativity for 24 or more months and more than ...

2. jnj.com jnj.com/media-center/press-releases/darzalex-faspro-daratumumab-and-hyaluronidase-fihj-based-regimens-demonstrate-improved-rates-of-minimal-residual-disease-mrd-negativity-and-progression-free-survival-in-patients-with-newly-diagnosed-multiple-myeloma

DARZALEX FASPRO® (daratumumab and hyaluronidase ... * “This regimen has the potential to improve outcomes for patients with newly diagnosed multiple myeloma who are ineligible for transplant or ...

3. jnjmedicalconnect.com jnjmedicalconnect.com/products/darzalex-faspro/medical-content/darzalex-faspro-daratumumab-and-hyaluronidase01

DARZALEX FASPRO® (daratumumab and hyaluronidase) A summary of clinical data regarding DARZALEX® (daratumumab) and DARZALEX FASPRO® (daratumumab and hyaluronidase) use in older patients.

4. aetna.com aetna.com/cpb/medical/data/900_999/0904.html?ref=counterforcehealth.org

Daratumumab (Darzalex) and Daratumumab and ... Darzalex Faspro is indicated for the treatment of adult patients with multiple myeloma: in combination with bortezomib, lenalidomide, and dexamethasone for ...

5. bloodcancerunited.org bloodcancerunited.org/resources/newsroom/fda-approval-new-treatment-indication-multiple-myeloma-drug

New Treatment Indication for Multiple Myeloma Drug This is the sixth indication for daratumumab plus hyaluronidase in patients with multiple myeloma. It was first approved in 2015 and can be given alone or in ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/761145s009lbl.pdf

Darzalex Faspro - accessdata.fda.gov Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO [see. Adverse Reactions (6.3)]. Systemic Reactions. In a ...

7. darzalexhcp.com darzalexhcp.com/frontline-dvrd/

Frontline DVRd - darzalex faspro Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®. Systemic Reactions. In a pooled safety population of 1249 ...

8. darzalex.com darzalex.com/isi/

Important Safety Information for DARZALEX® FASPRO Find important safety information for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj). See Full Prescribing and Safety Information.