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| ID | Type | Description | Link |
|---|---|---|---|
| JT 19521 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab and Hyaluronidase-fihj | Drug | Given SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | At Visit 3, Day 57 |
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perceptions of Home Based Anti-neoplastic Therapy | Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews. | Cycle 3 through Cycle 6, days 57-169 |
| Opportunity Cost |
Inclusion Criteria:
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) < 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:
Non-English Speaking
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| Name | Affiliation | Role |
|---|---|---|
| Adam R Binder, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 1,Baseline |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Binder, MD | Thomas Jefferson University | 215-955-8874 | Adam.binder@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2024 | Aug 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Questionnaire Administration | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Interview | Other | Ancillary studies |
|
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. |
| 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. | 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. | 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. | 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. | At Visit 8, Day 197 |
| 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At Visit 6, Day 141 |
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
| At Visit 1, Baseline |
| Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | At Visit 2, Day 29 |
| Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | At Visit 3, Day 57 |
| Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | At Visit 4, Day 85 |
| Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | At Visit 5, Day 113 |
| Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | At Visit 6, Day 141 |
| Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | At Visit 7, Day 169 |
| Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | At Visit 8, Day 197 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 2, Day29 |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 3, Day 57 |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 4, Day 85 |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 5, Day 113 |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 6, Day 141 |
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| Primary | 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. | Although 20 participants were enrolled in the study, not all participants completed the CTSQ at each time point. As a result, only the 16 participants who provided complete and analyzable responses were included in the analysis for this outcome. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 7, Day 169 |
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| Primary | 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. | Although 20 participants were enrolled in the study, not all participants completed the CTSQ at each time point. As a result, only the 17 participants who provided complete and analyzable responses were included in the analysis for this outcome. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 8, Day 197 |
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| Secondary | 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). | Participants who received at least one dose in the home setting during cycle 3. | Posted | Count of Participants | Participants | At Visit 3,Day 57 |
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| Secondary | 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). | Participants who received at least one dose in the home setting during cycle 4. | Posted | Count of Participants | Participants | At Visit 4,Day 85 |
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| Secondary | 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). | Participants who received at least one dose in the home setting during cycle 5. | Posted | Count of Participants | Participants | At Visit 5,Day 113 |
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| Secondary | 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). | Participants who received at least one dose in the home setting during cycle 6. | Posted | Count of Participants | Participants | At Visit 6,Day 141 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 1, Baseline |
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| Secondary | 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. | Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 2, Day 29 |
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| Secondary | 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. | Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 3, Day 57 |
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| Secondary | 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. | Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 4, Day 85 |
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| Secondary | 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. | Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 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. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 5, Day 113 |
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| Secondary | 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. | Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 17 participants who provided complete and analyzable responses were included in the analysis for this outcome. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 6, Day 141 |
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| Secondary | 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. | Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 16 participants who provided complete and analyzable responses were included in the analysis for this outcome. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 7, Day 169 |
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| Secondary | 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. | Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 17 participants who provided complete and analyzable responses were included in the analysis for this outcome. | Posted | Mean | Standard Deviation | scores on a scale (0-100) | At Visit 8, Day 197 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-44) | At Visit 1, Baseline |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-44) | At Visit 2, Day 29 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-44) | At Visit 3, Day 57 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-44) | At Visit 4, Day 85 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-44) | At Visit 5, Day 113 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-44) | At Visit 6, Day 141 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-44) | At Visit 7, Day 169 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale (0-44) | At Visit 8, Day 197 |
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| Secondary | 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. | All participants who received Darzalex-Faspro during specified cycles. | Posted | Number | adverse events | Cycle 3 through Cycle 6, days 57-169 |
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| Secondary | 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. | All participants who received Darzalex-Faspro during specified cycles. | Posted | Number | adverse events | Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197 |
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| Secondary | 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. | All participants who received Darzalex-Faspro in the home setting during cycles 3-6. | Posted | Count of Participants | Participants | At Visit 3, Day 57 |
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| Secondary | 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. | All participants who received Darzalex-Faspro in the home setting during cycles 3-6. | Posted | Count of Participants | Participants | At Visit 4, Day 85 |
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| Secondary | 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. | All participants who received Darzalex-Faspro in the home setting during cycles 3-6. | Posted | Count of Participants | Participants | At Visit 5, Day 113 |
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| Secondary | 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. | All participants who received Darzalex-Faspro in the home setting during cycles 3-6. No barriers were identified. | Posted | Count of Participants | Participants | At Visit 6, Day 141 |
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| Other Pre-specified | Patient Perceptions of Home Based Anti-neoplastic Therapy | Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews. | Posted | Count of Participants | Participants | Cycle 3 through Cycle 6, days 57-169 |
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| Other Pre-specified | Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | Surveys were collected using the Oncology Opportunity Cost Assessment Tool (OOCAT) during the home administration period. However, the data could not be analyzed due to incorrectly completed responses. As a result, no summary statistics or conclusions could be drawn from the opportunity cost data. | Posted | At Visit 1, Baseline |
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| Other Pre-specified | Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | Surveys were collected using the Oncology Opportunity Cost Assessment Tool (OOCAT) during the home administration period. However, the data could not be analyzed due to incorrectly completed responses. As a result, no summary statistics or conclusions could be drawn from the opportunity cost data. | Posted | At Visit 2, Day 29 |
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| Other Pre-specified | Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | Surveys were collected using the Oncology Opportunity Cost Assessment Tool (OOCAT) during the home administration period. However, the data could not be analyzed due to incorrectly completed responses. As a result, no summary statistics or conclusions could be drawn from the opportunity cost data. | Posted | At Visit 3, Day 57 |
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| Other Pre-specified | Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | Surveys were collected using the Oncology Opportunity Cost Assessment Tool (OOCAT) during the home administration period. However, the data could not be analyzed due to incorrectly completed responses. As a result, no summary statistics or conclusions could be drawn from the opportunity cost data. | Posted | At Visit 4, Day 85 |
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| Other Pre-specified | Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | Surveys were collected using the Oncology Opportunity Cost Assessment Tool (OOCAT) during the home administration period. However, the data could not be analyzed due to incorrectly completed responses. As a result, no summary statistics or conclusions could be drawn from the opportunity cost data. | Posted | At Visit 5, Day 113 |
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| Other Pre-specified | Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | Surveys were collected using the Oncology Opportunity Cost Assessment Tool (OOCAT) during the home administration period. However, the data could not be analyzed due to incorrectly completed responses. As a result, no summary statistics or conclusions could be drawn from the opportunity cost data. | Posted | At Visit 6, Day 141 |
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| Other Pre-specified | Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | Surveys were collected using the Oncology Opportunity Cost Assessment Tool (OOCAT) during the home administration period. However, the data could not be analyzed due to incorrectly completed responses. As a result, no summary statistics or conclusions could be drawn from the opportunity cost data. | Posted | At Visit 7, Day 169 |
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| Other Pre-specified | Opportunity Cost | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. | Surveys were collected using the Oncology Opportunity Cost Assessment Tool (OOCAT) during the home administration period. However, the data could not be analyzed due to incorrectly completed responses. As a result, no summary statistics or conclusions could be drawn from the opportunity cost data. | Posted | At Visit 8, Day 197 |
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|
| 0 |
| 20 |
| 3 |
| 20 |
| 18 |
| 20 |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Dental carriers | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
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| Edema- limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Flue like symptoms | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
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| gastritis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Gastrointestinal disorders- other | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | blood in vomit |
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| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| infections and infestations- other | Infections and infestations | CTCAE (5.0) | Systematic Assessment | vertebral osteomyelitis discitis with epidural abscess |
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| infusion related reaction (zometa) | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Injection site reaction | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Metabolism and nutrition disorders- other | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Vitamin B-12 deficiency |
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| mucositis- oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| muscle weakness- lower limbs | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified- other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment | Benign prostatic hyperplasia |
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| Neoplasms benign, malignant and unspecified- other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment | bladder mass |
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| non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Oral pain (pain in lower jaw) | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Teeth grinding |
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| Peripheral sensory neuropathy | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Rash Maculopapular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| rectal ulcer | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| sinusitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Skin and subcutaneous disorders- other | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | rash over leg, seems like bruising from seam of pants |
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| Skin and subcutaneous disorders- other | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | rash, drug eruption |
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| Skin and subcutaneous disorders- other | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | bilateral atopic dermatitis of the ear |
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| skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| skin infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| syncope | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| upper respiratory infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| urinary frequency | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
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| urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| vascular disorders- other | Vascular disorders | CTCAE (5.0) | Systematic Assessment | abnormal vision, floaters in the left eye, thinning of blood vessels |
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| viremia | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| vision decreased | Eye disorders | CTCAE (5.0) | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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Not provided
Not provided
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
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| Positive : More Time in the Day for Work/Other Activities |
|
| Positive : Eliminated Travel Inconveniences |
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| Positive : Acceptability of Home Blood Draws |
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| Positive : Satisfaction with Home Infusion Staff |
|
| Negative : Wait Times |
|