Plasma Cell MyelomaPhase 4NCT05511428

Home Based Daratumumab Administration for Patients With Multiple Myeloma

A Phase 4 study testing Daratumumab and Hyaluronidase-fihj, Questionnaire Administration and Quality-of-Life Assessment in people with Plasma Cell Myeloma, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Plasma Cell Myeloma
What is being tested?: Daratumumab and Hyaluronidase-fihj, Questionnaire Administration and Quality-of-Life Assessment
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 8 Nov 2022to 22 May 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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) < 2.5 times upper limit of normal (ULN)
Bilirubin < 2 times ULN
Creatinine clearance (CrCl) >= 20 mL/min for single agent subcutaneous (SC) daratumumab. For combination studies: with lenalidomide >= 30 mL/min
English speaking

Who cannot join

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

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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) < 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is < 50% of predicted normal
Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate
Clinically significant cardiac disease, including:
Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)
Uncontrolled cardiac arrhythmia
Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval as corrected by Fridericia's formula > 470 msec
Non-English Speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

Evaluate treatment burden (using the Cancer Treatment Satisfaction Questionnaire [CTSQ]).

SECONDARY OBJECTIVES:

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:

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.

Conditions: Plasma Cell Myeloma
Being tested: Daratumumab and Hyaluronidase-fihj, Questionnaire Administration, Quality-of-Life Assessment, Interview
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Daratumumab and Hyaluronidase-fihjDrug
Also called DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab with rHuPH20
Given SC
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
InterviewOther
Ancillary studies

Study groups in NCT05511428
Study group	Role	What they receive
Treatment (daratumumab and hyaluronidase-fihj)	Experimental	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. Receives: Drug: Daratumumab and Hyaluronidase-fihj; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Interview

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Measured: At Visit 1,Baseline
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Measured: At Visit 2, Day29
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 3
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Measured: At Visit 3, Day 57
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Measured: At Visit 4, Day 85
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 5
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Measured: At Visit 5, Day 113
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 6
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Measured: At Visit 6, Day 141
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 7
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Measured: At Visit 7, Day 169
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 8
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Measured: At Visit 8, Day 197

Secondary outcomes (26)

Number of Participants With Medication Adherence in Home Setting During Cycle 3
Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).
Measured: At Visit 3,Day 57
Number of Participants With Medication Adherence in Home Setting During Cycle 4
Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).
Measured: At Visit 4,Day 85
Number of Participants With Medication Adherence in Home Setting During Cycle 5
Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).
Measured: At Visit 5,Day 113
Number of Participants With Medication Adherence in Home Setting During Cycle 6
Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).
Measured: At Visit 6,Day 141
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Measured: At Visit 1, Baseline
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Measured: At Visit 2, Day 29
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Measured: At Visit 3, Day 57
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Measured: At Visit 4, Day 85
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Measured: At Visit 5, Day 113
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Measured: At Visit 6, Day 141
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Measured: At Visit 7, Day 169
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Measured: At Visit 8, Day 197
Financial Toxicity
Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.
Measured: At Visit 1, Baseline
Financial Toxicity
Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.
Measured: At Visit 2, Day 29
Financial Toxicity
Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.
Measured: At Visit 3, Day 57
Financial Toxicity
Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.
Measured: At Visit 4, Day 85
Financial Toxicity
Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.
Measured: At Visit 5, Day 113
Financial Toxicity
Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.
Measured: At Visit 6, Day 141
Financial Toxicity
Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.
Measured: At Visit 7, Day 169
Financial Toxicity
Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.
Measured: At Visit 8, Day 197
Number of Adverse Events During Home Administration
Safety will be evaluated through collection of adverse events. Total number of adverse events occurring more than 1% of the time that occured during cycle 3-6, when Darzalex-Faspro was administered at home.
Measured: Cycle 3 through Cycle 6, days 57-169
Number of Adverse Events During Infusion Center Administration
Safety will be evaluated through collection of adverse events. Total number of adverse events that occurred more than 1% of the time during cycles 1, 2, 7, and 8 when Darzalex-Faspro was administered at the infusion center.
Measured: Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197
Number of Patients Reporting Barriers to Home Administration At Cycle 3
Barriers to receiving home administration were assessed using binary (yes/no) questionnaire administered at Cycle 3. Participants were asked whether they experienced any barriers to home infusion, including delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication. The outcome reflects the total number of participants who responded, "yes" to any barriers to home based therapy, based on binary (yes/no) questionnaire.
Measured: At Visit 3, Day 57
Number of Patients Reporting Barriers to Home Administration At Cycle 4
Barriers to receiving home administration were assessed using binary (yes/no) questionnaire administered at Cycle 4. Participants were asked whether they experienced any barriers to home infusion, including delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication. The outcome reflects the total number of participants who responded, "yes" to any barriers to home based therapy, based on binary (yes/no) questionnaire.
Measured: At Visit 4, Day 85
Number of Patients Reporting Barriers to Home Administration At Cycle 5
Barriers to receiving home administration were assessed using binary (yes/no) questionnaire administered at Cycle 5. Participants were asked whether they experienced any barriers to home infusion, including delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication. The outcome reflects the total number of participants who responded, "yes" to any barriers to home based therapy, based on binary (yes/no) questionnaire.
Measured: At Visit 5, Day 113
Number of Patients Reporting Barriers to Home Administration At Cycle 6
Barriers to receiving home administration were assessed using binary (yes/no) questionnaire administered at Cycle 6. Participants were asked whether they experienced any barriers to home infusion, including delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication. The outcome reflects the total number of participants who responded, "yes" to any barriers to home based therapy, based on binary (yes/no) questionnaire.
Measured: At Visit 6, Day 141

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 202222 May 2024

First posted23 Aug 2022
Study start8 Nov 2022
Primary completion22 May 2024
Study completion22 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05511428
Sponsor's protocol ID: 22C.210
Other IDs: JT 19521
Status last verified: Nov 2025
First submitted: 19 Aug 2022
Last updated: 21 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma
ClinicalTrials.gov ID: NCT05511428
Acronym / sponsor ID: 22C.210
Conditions: Plasma Cell Myeloma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Thomas Jefferson UniversityUniversity, hospital or other
Collaborators: Janssen Scientific Affairs, LLC
Study start: 8 Nov 2022 (actual)
Primary completion: 22 May 2024 (actual)
Study completion: 22 May 2024 (actual)
First posted: 23 Aug 2022 (actual)
Results: Posted 21 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

Evaluate treatment burden (using the Cancer Treatment Satisfaction Questionnaire [CTSQ]).

SECONDARY OBJECTIVES:

Determine adherence to home delivery of daratumumab and hyaluronidase-fihj (darzalex faspro).

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:

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:

After completion of study treatment, patients are followed up at 2 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (daratumumab and hyaluronidase-fihj)	Experimental	Drug: Daratumumab and Hyaluronidase-fihj, Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Other: InterviewPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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)

Key exclusion criteria (15 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Daratumumab and Hyaluronidase-fihjAlso: DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab with rHuPH20Given SC	Drug	Treatment (daratumumab and hyaluronidase-fihj)
Questionnaire AdministrationAncillary studies	Other	Treatment (daratumumab and hyaluronidase-fihj)
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Treatment (daratumumab and hyaluronidase-fihj)
InterviewAncillary studies	Other	Treatment (daratumumab and hyaluronidase-fihj)

Primary outcome

Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1
Time frame: At Visit 1,Baseline
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2
Time frame: At Visit 2, Day29
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 3
Time frame: At Visit 3, Day 57
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4
Time frame: At Visit 4, Day 85
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 5
Time frame: At Visit 5, Day 113
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 6
Time frame: At Visit 6, Day 141
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 7
Time frame: At Visit 7, Day 169
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 8
Time frame: At Visit 8, Day 197
Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

26 secondary outcomes

Number of Participants With Medication Adherence in Home Setting During Cycle 3
Time frame: At Visit 3,Day 57
Number of Participants With Medication Adherence in Home Setting During Cycle 4
Time frame: At Visit 4,Day 85
Number of Participants With Medication Adherence in Home Setting During Cycle 5
Time frame: At Visit 5,Day 113
Number of Participants With Medication Adherence in Home Setting During Cycle 6
Time frame: At Visit 6,Day 141
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1
Time frame: At Visit 1, Baseline
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2
Time frame: At Visit 2, Day 29
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3
Time frame: At Visit 3, Day 57
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4
Time frame: At Visit 4, Day 85
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5
Time frame: At Visit 5, Day 113
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6
Time frame: At Visit 6, Day 141
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7
Time frame: At Visit 7, Day 169
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8
Time frame: At Visit 8, Day 197
Financial Toxicity
Time frame: At Visit 1, Baseline
Financial Toxicity
Time frame: At Visit 2, Day 29
Financial Toxicity
Time frame: At Visit 3, Day 57
Financial Toxicity
Time frame: At Visit 4, Day 85
Financial Toxicity
Time frame: At Visit 5, Day 113
Financial Toxicity
Time frame: At Visit 6, Day 141
Financial Toxicity
Time frame: At Visit 7, Day 169
Financial Toxicity
Time frame: At Visit 8, Day 197
Number of Adverse Events During Home Administration
Time frame: Cycle 3 through Cycle 6, days 57-169
Number of Adverse Events During Infusion Center Administration
Time frame: Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197
Number of Patients Reporting Barriers to Home Administration At Cycle 3
Time frame: At Visit 3, Day 57
Number of Patients Reporting Barriers to Home Administration At Cycle 4
Time frame: At Visit 4, Day 85
Number of Patients Reporting Barriers to Home Administration At Cycle 5
Time frame: At Visit 5, Day 113
Number of Patients Reporting Barriers to Home Administration At Cycle 6
Time frame: At Visit 6, Day 141

Results and safety

Results posted to the registry on 21 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (daratumumab and hyaluronidase-fihj)	20	18

Primary outcome: Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1

Time frame: At Visit 1,Baseline. Mean (Standard Deviation). Unit: scores on a scale (0-100)

Measure	Treatment (daratumumab and hyaluronidase-fihj) n = 19
Value	87.2 (10.5)

Population analysed: Although 20 participants were enrolled in the study, not all participants completed the CTSQ at each time point. As a result, only the 19 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Primary outcome: Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2

Time frame: At Visit 2, Day29. Mean (Standard Deviation). Unit: scores on a scale (0-100)

Measure	Treatment (daratumumab and hyaluronidase-fihj) n = 19
Value	87.4 (7.9)

Primary outcome: Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 3

Time frame: At Visit 3, Day 57. Mean (Standard Deviation). Unit: scores on a scale (0-100)

Measure	Treatment (daratumumab and hyaluronidase-fihj) n = 18
Value	89.3 (10.2)

Population analysed: Although 20 participants were enrolled in the study, not all participants completed the CTSQ at each time point. As a result, only the 18 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Primary outcome: Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4

Time frame: At Visit 4, Day 85. Mean (Standard Deviation). Unit: scores on a scale (0-100)

Measure	Treatment (daratumumab and hyaluronidase-fihj) n = 19
Value	86.1 (10.3)

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (daratumumab and hyaluronidase-fihj)	3 of 20 (15%)	18 of 20 (90%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam R Binder, MD principal investigator

Thomas Jefferson University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05511428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.