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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Visit 8, Day 197
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Visit 6, Day 141