Plasma Cell Myeloma
Conditions
Brief summary
This clinical trial tests the treatment effect of home based daratumumab administration in treating patients with multiple myeloma. Darzalex Faspro is a combination of two drugs (daratumumab and hyaluronidase) used to treat adults with multiple myeloma. Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase-fihj is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect. Standard medical care requires Darzalex-Faspro treatment be administered during visits to the cancer center. Receiving medication in the home setting, may decrease cost and burden of care in patients with multiple myeloma.
Detailed description
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.
Interventions
Given SC
OTHERQuestionnaire Administration
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERInterview
Ancillary studies
Sponsors
Janssen Scientific Affairs, LLC
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Male or female, aged greater than 18 years of age * Has a diagnosis of Multiple Myeloma * Is on the monthly phase of daratumumab (either intravenous \[IV\] or subcutaneous \[SubQ\]) based regimen (every 4 weeks) (either monotherapy or in combination with oral agents) * Is willing to receive daratumumab subcutaneous injections * Lives within the range of Jefferson Home Infusion Services * Patients are willing to allow home infusion company visit them and administer Darzalex-Faspro in the home * Women of reproductive potential must use highly effective contraception * Men of reproductive potential must use highly effective contraception * Absolute neutrophil count (ANC) \> 1,000 * Platelet count \> 50,000 * Aspartate aminotransferase (AST) / alanine transaminase (ALT) \< 2.5 times upper limit of normal (ULN) * Bilirubin \< 2 times ULN * Creatinine clearance (CrCl) \>= 20 mL/min for single agent subcutaneous (SC) daratumumab. For combination studies: with lenalidomide \>= 30 mL/min * English speaking
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: * Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV) * Uncontrolled cardiac arrhythmia * Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval as corrected by Fridericia's formula \> 470 msec * Non-English Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 8 | At Visit 8, Day 197 | Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle. |
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 7 | At Visit 7, Day 169 | Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle. |
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1 | At Visit 1,Baseline | Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle. |
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2 | At Visit 2, Day29 | Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle. |
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 3 | At Visit 3, Day 57 | Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle. |
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4 | At Visit 4, Day 85 | Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle. |
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 5 | At Visit 5, Day 113 | Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle. |
| Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 6 | At Visit 6, Day 141 | Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4 | At Visit 4, Day 85 | 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. |
| Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5 | At Visit 5, Day 113 | 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. |
| Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6 | At Visit 6, Day 141 | 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. |
| Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7 | At Visit 7, Day 169 | 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. |
| Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8 | At Visit 8, Day 197 | 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. |
| Number of Adverse Events During Home Administration | Cycle 3 through Cycle 6, days 57-169 | 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. |
| Number of Adverse Events During Infusion Center Administration | Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197 | 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. |
| Number of Patients Reporting Barriers to Home Administration At Cycle 3 | At Visit 3, Day 57 | 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. |
| Number of Patients Reporting Barriers to Home Administration At Cycle 4 | At Visit 4, Day 85 | 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. |
| Number of Patients Reporting Barriers to Home Administration At Cycle 5 | At Visit 5, Day 113 | 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. |
| Number of Patients Reporting Barriers to Home Administration At Cycle 6 | At Visit 6, Day 141 | 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. |
| Financial Toxicity | At Visit 1, Baseline | 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. |
| Number of Participants With Medication Adherence in Home Setting During Cycle 3 | At Visit 3,Day 57 | 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). |
| Number of Participants With Medication Adherence in Home Setting During Cycle 4 | At Visit 4,Day 85 | 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). |
| Number of Participants With Medication Adherence in Home Setting During Cycle 5 | At Visit 5,Day 113 | 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). |
| Number of Participants With Medication Adherence in Home Setting During Cycle 6 | At Visit 6,Day 141 | 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). |
| Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1 | At Visit 1, Baseline | 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. |
| Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2 | At Visit 2, Day 29 | 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. |
| Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3 | At Visit 3, Day 57 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Perceptions of Home Based Anti-neoplastic Therapy | Cycle 3 through Cycle 6, days 57-169 | Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews. |
| Opportunity Cost | At Visit 1, Baseline | Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Treatment (Daratumumab and Hyaluronidase-fihj) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 18 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
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.
Time frame: At Visit 1,Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1 | 87.2 scores on a scale (0-100) | Standard Deviation 10.5 |
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.
Time frame: At Visit 2, Day29
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2 | 87.4 scores on a scale (0-100) | Standard Deviation 7.9 |
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.
Time frame: At Visit 3, Day 57
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 3 | 89.3 scores on a scale (0-100) | Standard Deviation 10.2 |
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.
Time frame: At Visit 4, Day 85
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4 | 86.1 scores on a scale (0-100) | Standard Deviation 10.3 |
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.
Time frame: At Visit 5, Day 113
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 5 | 88.2 scores on a scale (0-100) | Standard Deviation 9.5 |
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.
Time frame: At Visit 6, Day 141
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 6 | 85.7 scores on a scale (0-100) | Standard Deviation 14.1 |
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.
Time frame: At Visit 7, Day 169
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 7 | 89.7 scores on a scale (0-100) | Standard Deviation 11.8 |
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.
Time frame: At Visit 8, Day 197
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 8 | 90.1 scores on a scale (0-100) | Standard Deviation 12.7 |
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.
Time frame: At Visit 6, Day 141
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Financial Toxicity | 26.6 scores on a scale (0-44) | Standard Deviation 10.4 |
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.
Time frame: At Visit 1, Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Financial Toxicity | 27.0 scores on a scale (0-44) | Standard Deviation 7.8 |
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.
Time frame: At Visit 2, Day 29
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Financial Toxicity | 28.5 scores on a scale (0-44) | Standard Deviation 9.9 |
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.
Time frame: At Visit 3, Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Financial Toxicity | 24.8 scores on a scale (0-44) | Standard Deviation 9.7 |
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.
Time frame: At Visit 4, Day 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Financial Toxicity | 28 scores on a scale (0-44) | Standard Deviation 9.2 |
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.
Time frame: At Visit 5, Day 113
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Financial Toxicity | 26.8 scores on a scale (0-44) | Standard Deviation 10.4 |
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.
Time frame: At Visit 7, Day 169
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Financial Toxicity | 24.7 scores on a scale (0-44) | Standard Deviation 9.6 |
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.
Time frame: At Visit 8, Day 197
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Financial Toxicity | 27.7 scores on a scale (0-44) | Standard Deviation 9 |
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.
Time frame: At Visit 1, Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1 | 64.2 scores on a scale (0-100) | Standard Deviation 21.3 |
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.
Time frame: At Visit 2, Day 29
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2 | 69.3 scores on a scale (0-100) | Standard Deviation 17.4 |
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.
Time frame: At Visit 3, Day 57
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3 | 64.4 scores on a scale (0-100) | Standard Deviation 15.9 |
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.
Time frame: At Visit 4, Day 85
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4 | 65.8 scores on a scale (0-100) | Standard Deviation 19.6 |
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.
Time frame: At Visit 5, Day 113
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5 | 57.5 scores on a scale (0-100) | Standard Deviation 18.4 |
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.
Time frame: At Visit 6, Day 141
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6 | 69.1 scores on a scale (0-100) | Standard Deviation 20.8 |
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.
Time frame: At Visit 7, Day 169
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7 | 69.3 scores on a scale (0-100) | Standard Deviation 18.4 |
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.
Time frame: At Visit 8, Day 197
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8 | 62.3 scores on a scale (0-100) | Standard Deviation 18.9 |
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.
Time frame: Cycle 3 through Cycle 6, days 57-169
Population: All participants who received Darzalex-Faspro during specified cycles.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Adverse Events During Home Administration | 69 adverse events |
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.
Time frame: Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197
Population: All participants who received Darzalex-Faspro during specified cycles.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Adverse Events During Infusion Center Administration | 82 adverse events |
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).
Time frame: At Visit 3,Day 57
Population: Participants who received at least one dose in the home setting during cycle 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Participants With Medication Adherence in Home Setting During Cycle 3 | 19 Participants |
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).
Time frame: At Visit 4,Day 85
Population: Participants who received at least one dose in the home setting during cycle 4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Participants With Medication Adherence in Home Setting During Cycle 4 | 19 Participants |
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).
Time frame: At Visit 5,Day 113
Population: Participants who received at least one dose in the home setting during cycle 5.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Participants With Medication Adherence in Home Setting During Cycle 5 | 19 Participants |
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).
Time frame: At Visit 6,Day 141
Population: Participants who received at least one dose in the home setting during cycle 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Participants With Medication Adherence in Home Setting During Cycle 6 | 19 Participants |
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.
Time frame: At Visit 3, Day 57
Population: All participants who received Darzalex-Faspro in the home setting during cycles 3-6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Patients Reporting Barriers to Home Administration At Cycle 3 | 0 Participants |
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.
Time frame: At Visit 4, Day 85
Population: All participants who received Darzalex-Faspro in the home setting during cycles 3-6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Patients Reporting Barriers to Home Administration At Cycle 4 | 0 Participants |
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.
Time frame: At Visit 5, Day 113
Population: All participants who received Darzalex-Faspro in the home setting during cycles 3-6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Patients Reporting Barriers to Home Administration At Cycle 5 | 0 Participants |
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.
Time frame: At Visit 6, Day 141
Population: All participants who received Darzalex-Faspro in the home setting during cycles 3-6. No barriers were identified.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Number of Patients Reporting Barriers to Home Administration At Cycle 6 | 0 Participants |
Other Pre-specified
Opportunity Cost
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
Time frame: At Visit 2, Day 29
Population: 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.
Other Pre-specified
Opportunity Cost
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
Time frame: At Visit 1, Baseline
Population: 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.
Other Pre-specified
Opportunity Cost
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
Time frame: At Visit 8, Day 197
Population: 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.
Other Pre-specified
Opportunity Cost
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
Time frame: At Visit 7, Day 169
Population: 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.
Other Pre-specified
Opportunity Cost
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
Time frame: At Visit 6, Day 141
Population: 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.
Other Pre-specified
Opportunity Cost
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
Time frame: At Visit 4, Day 85
Population: 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.
Other Pre-specified
Opportunity Cost
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
Time frame: At Visit 3, Day 57
Population: 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.
Other Pre-specified
Opportunity Cost
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
Time frame: At Visit 5, Day 113
Population: 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.
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.
Time frame: Cycle 3 through Cycle 6, days 57-169
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | Patient Perceptions of Home Based Anti-neoplastic Therapy | Positive : Familiarity | 2 Participants |
| Treatment (daratumumab and hyaluronidase-fihj) | Patient Perceptions of Home Based Anti-neoplastic Therapy | Positive : Overall Comfort | 3 Participants |
| Treatment (daratumumab and hyaluronidase-fihj) | Patient Perceptions of Home Based Anti-neoplastic Therapy | Positive : Ability to Rest After Treatment | 3 Participants |
| Treatment (daratumumab and hyaluronidase-fihj) | Patient Perceptions of Home Based Anti-neoplastic Therapy | Positive : More Time in the Day for Work/Other Activities | 3 Participants |
| Treatment (daratumumab and hyaluronidase-fihj) | Patient Perceptions of Home Based Anti-neoplastic Therapy | Positive : Eliminated Travel Inconveniences | 3 Participants |
| Treatment (daratumumab and hyaluronidase-fihj) | Patient Perceptions of Home Based Anti-neoplastic Therapy | Positive : Acceptability of Home Blood Draws | 2 Participants |
| Treatment (daratumumab and hyaluronidase-fihj) | Patient Perceptions of Home Based Anti-neoplastic Therapy | Positive : Satisfaction with Home Infusion Staff | 2 Participants |
| Treatment (daratumumab and hyaluronidase-fihj) | Patient Perceptions of Home Based Anti-neoplastic Therapy | Negative : Wait Times | 6 Participants |