Home Based Daratumumab Administration for Patients With Multiple Myeloma

Plasma Cell Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05511428
• Other study ID #: 22C.210
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: November 8, 2022
• Est. completion date: November 8, 2025

Study information

• Verified date: February 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 8, 2025
• Est. primary completion date: January 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Drug:
• Daratumumab and Hyaluronidase-fihj
Given SC

Other:
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies
• Interview
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient perceptions of home based anti-neoplastic therapy	Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews.	At Visit 3, Day 29
Other	Patient perceptions of home based anti-neoplastic therapy	Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews.	At Visit 4, Day 57
Other	Patient perceptions of home based anti-neoplastic therapy	Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews.	At Visit 5, Day 85
Other	Patient perceptions of home based anti-neoplastic therapy	Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews.	At Visit 6, Day 113
Other	Opportunity cost	Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.	At Visit 1, Baseline
Other	Opportunity cost	Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.	At Visit 2, Day 29
Other	Opportunity cost	Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.	At Visit 3, Day 57
Other	Opportunity cost	Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.	At Visit 4, Day 85
Other	Opportunity cost	Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.	At Visit 5, Day 113
Other	Opportunity cost	Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.	At Visit 6, Day 141
Other	Opportunity cost	Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.	At Visit 7, Day 169
Other	Opportunity cost	Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.	At Visit 8, Day 197
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Financial toxicity	Financial toxicity will be measured using the COST survey.	At Visit 1, Baseline
Secondary	Financial toxicity	Financial toxicity will be measured using the COST survey.	At Visit 2, Day 29
Secondary	Financial toxicity	Financial toxicity will be measured using the COST survey.	At Visit 3, Day 57
Secondary	Financial toxicity	Financial toxicity will be measured using the COST survey.	At Visit 4, Day 85
Secondary	Financial toxicity	Financial toxicity will be measured using the COST survey.	At Visit 5, Day 113
Secondary	Financial toxicity	Financial toxicity will be measured using the COST survey.	At Visit 6, Day 141
Secondary	Financial toxicity	Financial toxicity will be measured using the COST survey.	At Visit 7, Day 169
Secondary	Financial toxicity	Financial toxicity will be measured using the COST survey.	At Visit 8, Day 197
Secondary	Incidence of adverse events	Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro	At Visit 2, Day 29
Secondary	Incidence of adverse events	Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro	At Visit 3, Day 57
Secondary	Incidence of adverse events	Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro	At Visit 4, Day 85
Secondary	Incidence of adverse events	Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro	At Visit 5, Day 113
Secondary	Incidence of adverse events	Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro	At Visit 6, Day 141
Secondary	Incidence of adverse events	Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro	At Visit 7, Day 169
Secondary	Incidence of adverse events	Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro	At Visit 8, Day 197
Secondary	Incidence of adverse events	Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro	At Visit 9, Day 198
Secondary	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
Secondary	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
Secondary	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
Secondary	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