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Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Start Date
November 8, 2022
Primary Completion Date
May 22, 2024
Completion Date
May 22, 2024
Last Updated
November 21, 2025
20
ACTUAL participants
Daratumumab and Hyaluronidase-fihj
DRUG
Questionnaire Administration
OTHER
Quality-of-Life Assessment
OTHER
Interview
OTHER
Lead Sponsor
Thomas Jefferson University
Collaborators
NCT06356571
NCT05334069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05312255