Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Daratumumab and Hyaluronidase-fihj (Drug)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Interview (Other)
结局指标
主要结局
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 7
时间窗: 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 8
时间窗: 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.
次要结局
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4(At Visit 4, Day 85)
- Number of Participants With Medication Adherence in Home Setting During Cycle 3(At Visit 3,Day 57)
- Number of Participants With Medication Adherence in Home Setting During Cycle 4(At Visit 4,Day 85)
- Number of Participants With Medication Adherence in Home Setting During Cycle 5(At Visit 5,Day 113)
- Number of Participants With Medication Adherence in Home Setting During Cycle 6(At Visit 6,Day 141)
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1(At Visit 1, Baseline)
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2(At Visit 2, Day 29)
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3(At Visit 3, Day 57)
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5(At Visit 5, Day 113)
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6(At Visit 6, Day 141)
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7(At Visit 7, Day 169)
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8(At Visit 8, Day 197)
- Financial Toxicity(At Visit 8, Day 197)
- Number of Adverse Events During Home Administration(Cycle 3 through Cycle 6, days 57-169)
- Number of Adverse Events During Infusion Center Administration(Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197)
- Number of Patients Reporting Barriers to Home Administration At Cycle 3(At Visit 3, Day 57)
- Number of Patients Reporting Barriers to Home Administration At Cycle 4(At Visit 4, Day 85)
- Number of Patients Reporting Barriers to Home Administration At Cycle 5(At Visit 5, Day 113)
- Number of Patients Reporting Barriers to Home Administration At Cycle 6(At Visit 6, Day 141)