Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-03-09 @ 9:03 AM
Study NCT ID:
NCT05511428
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2022-08-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Home Based Daratumumab Administration for Patients With Multiple Myeloma
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JT 19521 | OTHER | JeffTrial Number | View |