Phase 4
Completed N=20
Home Based Daratumumab Administration for Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT05511428 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Nov 2025
Primary outcomePrimary: 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)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 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 |
— | — |
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. Informational only — not medical advice.