Phase 4
N=20
Home Based Daratumumab Administration for Patients With Multiple Myeloma
Plasma Cell Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT05511428 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Nov 2025
Primary outcome: Primary: Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1 — 87.2 scores on a scale (0-100)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Daratumumab and Hyaluronidase-fihj (Drug); Questionnaire Administration (Other); Quality-of-Life Assessment (Other); Interview (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1 |
87.2 | — |
| PRIMARY Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2 |
87.4 | — |
| PRIMARY Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 3 |
89.3 | — |
| PRIMARY Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4 |
86.1 | — |
| PRIMARY Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 5 |
88.2 | — |
| PRIMARY Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 6 |
85.7 | — |
| PRIMARY Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 7 |
89.7 | — |
| PRIMARY Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 8 |
90.1 | — |
| SECONDARY Number of Participants With Medication Adherence in Home Setting During Cycle 3 |
19 | — |
| SECONDARY Number of Participants With Medication Adherence in Home Setting During Cycle 4 |
19 | — |
| SECONDARY Number of Participants With Medication Adherence in Home Setting During Cycle 5 |
19 | — |
| SECONDARY Number of Participants With Medication Adherence in Home Setting During Cycle 6 |
19 | — |
| SECONDARY Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1 |
64.2 | — |
| SECONDARY Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2 |
69.3 | — |
| SECONDARY Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3 |
64.4 | — |
| SECONDARY Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4 |
65.8 | — |
| SECONDARY Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5 |
57.5 | — |
| SECONDARY Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6 |
69.1 | — |
| SECONDARY Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7 |
69.3 | — |
| SECONDARY Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8 |
62.3 | — |
| SECONDARY Financial Toxicity |
27.7 | — |
| SECONDARY Financial Toxicity |
27.7 | — |
| SECONDARY Financial Toxicity |
27.7 | — |
| SECONDARY Financial Toxicity |
27.7 | — |
| SECONDARY Financial Toxicity |
27.7 | — |
| SECONDARY Financial Toxicity |
27.7 | — |
| SECONDARY Financial Toxicity |
27.7 | — |
| SECONDARY Financial Toxicity |
27.7 | — |
| SECONDARY Number of Adverse Events During Home Administration |
69 | — |
| SECONDARY Number of Adverse Events During Infusion Center Administration |
82 | — |
| SECONDARY Number of Patients Reporting Barriers to Home Administration At Cycle 3 |
— | — |
| SECONDARY Number of Patients Reporting Barriers to Home Administration At Cycle 4 |
— | — |
| SECONDARY Number of Patients Reporting Barriers to Home Administration At Cycle 5 |
— | — |
| SECONDARY Number of Patients Reporting Barriers to Home Administration At Cycle 6 |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Able to provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged greater than 18 years of age
- Has a diagnosis of Multiple Myeloma
- Is on the monthly phase of daratumumab (either intravenous [IV] or subcutaneous [SubQ]) based regimen (every 4 weeks) (either monotherapy or in combination with oral agents)
- Is willing to receive daratumumab subcutaneous injections
- Lives within the range of Jefferson Home Infusion Services
- Patients are willing to allow home infusion company visit them and administer Darzalex-Faspro in the home
- Women of reproductive potential must use highly effective contraception
- Men of reproductive potential must use highly effective contraception
- Absolute neutrophil count (ANC) > 1,000
- Platelet count > 50,000
- Aspartate aminotransferase (AST) / alanine transaminase (ALT) = 20 mL/min for single agent subcutaneous (SC) daratumumab. For combination studies: with lenalidomide >= 30 mL/min
- English speaking
Exclusion Criteria
- Receiving daratumumab for an indication other than multiple myeloma
- Receiving daratumumab in combination with other IV or subcutaneous therapy
- Pregnancy or lactation
- Known allergic reactions to components of the study product(s)
- Uncontrolled human immunodeficiency virus (HIV)
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]) who are not on hepatitis B prophylaxis. Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive and not on Hep B prophylaxis will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV deoxyribonucleic acid (DNA) by PCR
- Patients with reactivation of hepatitis B will be excluded
- Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as a viremia at least 12 weeks after completion of antiviral therapy)
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 470 msec
- Non-English Speaking
Data sourced from ClinicalTrials.gov (NCT05511428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.