Home Based Daratumumab Administration for Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma

Conditions
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Plasma Cell Myeloma

Intervention / Treatment
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* Drug: Daratumumab and Hyaluronidase-fihj
* Other: Questionnaire Administration
* Other: Quality-of-Life Assessment
* Other: Interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (daratumumab and hyaluronidase-fihj)<br>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. | Drug: Daratumumab and Hyaluronidase-fihj<br>* Given SC<br>* Other names: Recombinant Human Hyaluronidase Mixed with Daratumumab;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Interview<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ) | Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05. | At Visit 1,Baseline | 
| Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ) | Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05. | At Visit 2, Day29 | 
| Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ) | Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05. | At Visit 3, Day 57 | 
| Treatment satisfactionwill be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ) | Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05. | At Visit 4, Day 85 | 
| Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ) | Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05. | At Visit 5, Day 113 | 
| Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ) | Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05. | At Visit 6, Day 141 | 
| Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ) | Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05. | At Visit 7, Day 169 | 
| Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ) | Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05. | At Visit 8, Day 197 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence in home setting | Adherence is defined as completing administration of medication in the home setting. 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). The model will be used to compute the average rate of home setting adherence with the corresponding 95% confidence interval. | At Visit 3,Day 57 | 
| Medication adherence in home setting | Adherence is defined as completing administration of medication in the home setting. 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). The model will be used to compute the average rate of home setting adherence with the corresponding 95% confidence interval. | At Visit 4,Day 85 | 
| Medication adherence in home setting | Adherence is defined as completing administration of medication in the home setting. 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). The model will be used to compute the average rate of home setting adherence with the corresponding 95% confidence interval. | At Visit 5,Day 113 | 
| Medication adherence in home setting | Adherence is defined as completing administration of medication in the home setting. 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). The model will be used to compute the average rate of home setting adherence with the corresponding 95% confidence interval. | At Visit 6,Day 141 | 
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). | Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). This would be rated on a 1- 4 scale with 4 being the worse outcome. | At Visit 1, Baseline | 
| Quality of life Questionnaire | Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).This would be rated on a 1- 4 scale with 4 being the worse outcome. | At Visit 2, Day 29 | 
| Quality of life Questionnaire | Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). This would be rated on a 1- 4 scale with 4 being the worse outcome. | At Visit 3, Day 57 | 
| Quality of life Questionnaire | Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). This would be rated on a 1- 4 scale with 4 being the worse outcome. | At Visit 4, Day 85 | 
| Quality of life Questionnaire | Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). This would be rated on a 1- 4 scale with 4 being the worse outcome. | At Visit 5, Day 113 | 
| Quality of life Questionnaire | Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).This would be rated on a 1- 4 scale with 4 being the worse outcome. | At Visit 6, Day 141 | 
| Quality of life Questionnaire | Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).This would be rated on a 1- 4 scale with 4 being the worse outcome. | At Visit 7, Day 169 | 
| Quality of life Questionnaire | Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).This would be rated on a 1- 4 scale with 4 being the worse outcome. | At Visit 8, Day 197 | 
| Financial toxicity | Financial toxicity will be measured using the COST survey. | At Visit 1, Baseline | 
| Financial toxicity | Financial toxicity will be measured using the COST survey. | At Visit 2, Day 29 | 
| Financial toxicity | Financial toxicity will be measured using the COST survey. | At Visit 3, Day 57 | 
| Financial toxicity | Financial toxicity will be measured using the COST survey. | At Visit 4, Day 85 | 
| Financial toxicity | Financial toxicity will be measured using the COST survey. | At Visit 5, Day 113 | 
| Financial toxicity | Financial toxicity will be measured using the COST survey. | At Visit 6, Day 141 | 
| Financial toxicity | Financial toxicity will be measured using the COST survey. | At Visit 7, Day 169 | 
| Financial toxicity | Financial toxicity will be measured using the COST survey. | At Visit 8, Day 197 | 
| Incidence of adverse events | Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro | At Visit 2, Day 29 | 
| Incidence of adverse events | Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro | At Visit 3, Day 57 | 
| Incidence of adverse events | Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro | At Visit 4, Day 85 | 
| Incidence of adverse events | Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro | At Visit 5, Day 113 | 
| Incidence of adverse events | Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro | At Visit 6, Day 141 | 
| Incidence of adverse events | Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro | At Visit 7, Day 169 | 
| Incidence of adverse events | Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro | At Visit 8, Day 197 | 
| Incidence of adverse events | Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro | At Visit 9, Day 198 | 
| Barriers to home administration | Barriers to home administration will be measured through a questionnaire administered to the subject that asks about any 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. Questions will have the same unit of measure Yes/No. | At Visit 3, Day 57 | 
| Barriers to home administration | Barriers to home administration will be measured through a questionnaire administered to the subject that asks about any 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. Questions have the same unit of measure Yes/No. | At Visit 4, Day 85 | 
| Barriers to home administration | Barriers to home administration will be measured through a questionnaire administered to the subject that asks about any 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. Questions have the same unit of measure Yes/No. | At Visit 5, Day 113 | 
| Barriers to home administration | Barriers to home administration will be measured through a questionnaire administered to the subject that asks about any 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. Questions have the same unit of measure Yes/No. | At Visit 6, Day 141 |