NCT05511428

Home Based Daratumumab Administration for Patients With Multiple Myeloma

Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate treatment burden (using the Cancer Treatment Satisfaction Questionnaire \[CTSQ\]). SECONDARY OBJECTIVES: I. Determine adherence to home delivery of daratumumab and hyaluronidase-fihj (darzalex faspro). II. Evaluate quality of life (using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ-30\]) based on site of care (home versus \[vs.\] infusion center). III. Evaluate financial burden (using the COST survey) based on site of care (home vs. infusion center). IV. Evaluate Safety of home administration of darzalex-faspro. V. Evaluate barriers to home administration. EXPLORATORY OBJECTIVES: I. Evaluate patient perceptions of home administration of anti-neoplastic therapy. II. Evaluate opportunity cost based on site of care (home vs. infusion center) (using the Oncology Opportunity Cost Assessment Tool \[OOCAT\] survey). OUTLINE: Patients receive daratumumab and hyaluronidase-fihj subcutaneously (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. After completion of study treatment, patients are followed up at 2 months.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab and Hyaluronidase-fihj	Given SC
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Interview	Ancillary studies

Timeline

• Start date: 2022-11-08
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2022-08-23
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study