Home-Based Daratumumab for Multiple Myeloma

Overseen By Adam Binder, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

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)

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

20 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Daratumumab for treating multiple myeloma?

Daratumumab has shown promising results in treating multiple myeloma, both alone and in combination with other drugs, by effectively targeting and killing cancer cells. Studies have demonstrated its ability to achieve significant response rates, including complete responses in some patients, and it is well-tolerated with manageable side effects. ^{1 2 3 4 5}

Is daratumumab safe for humans?

Daratumumab has been shown to have an acceptable safety profile in humans, with common side effects including low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and infusion-related reactions. These side effects were generally manageable and occurred in patients with multiple myeloma who had received previous treatments. ^{1 2 3 6 7}

How is the drug Daratumumab and Hyaluronidase-fihj unique for treating multiple myeloma?

This drug is unique because it combines Daratumumab, a monoclonal antibody targeting CD38 on myeloma cells, with Hyaluronidase-fihj, allowing for subcutaneous (under the skin) administration, which is quicker and more convenient than the traditional intravenous (IV) method. ^{1 3 8 9 10}

What is the purpose of this trial?

This clinical trial tests the treatment effect of home based daratumumab administration in treating patients with multiple myeloma. Darzalex Faspro is a combination of two drugs (daratumumab and hyaluronidase) used to treat adults with multiple myeloma. Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase-fihj is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect. Standard medical care requires Darzalex-Faspro treatment be administered during visits to the cancer center. Receiving medication in the home setting, may decrease cost and burden of care in patients with multiple myeloma.

Research Team

Adam R Binder, MD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

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]

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]

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, 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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Daratumumab: monoclonal antibody therapy to treat multiple myeloma. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

CyBorD-DARA is potent initial induction for MM and enhances ADCP: initial results of the 16-BCNI-001/CTRIAL-IE 16-02 study. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Disease and Patient Characteristics on Daratumumab Exposure and Clinical Outcomes in Relapsed or Refractory Multiple Myeloma. [2020]

6. England pubmed.ncbi.nlm.nih.gov

EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Daratumumab for the Treatment of Multiple Myeloma: A Review of Clinical Applicability and Operational Considerations. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

Subcutaneous delivery of daratumumab in Japanese patients with relapsed/refractory multiple myeloma. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

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

10. New Zealand pubmed.ncbi.nlm.nih.gov

Daratumumab: First Global Approval. [2018]