Home Based Daratumumab Administration for Patients With Multiple Myeloma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT05511428
Phase
PHASE4
Status
Completed

Conditions

  • Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab and Hyaluronidase-fihj — DRUG
    Given SC
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Interview — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Nov 8, 2022
Status verified
Nov 2025
Primary completion
May 22, 2024
Completion
May 22, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (daratumumab and hyaluronidase-fihj)
    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.

Primary Outcome Measure

Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1 [ Time Frame: At Visit 1,Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

Related Studies