Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
研究概览
简要总结
The main goal in this open label, phase four, prospective, non-randomized, sponsor-initiated multicenter feasibility study is to evaluate the feasibility and safety of self-administration of subcutaneously (SC) daratumumab in the patients with multiple myeloma in their own home. The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. To reduce potential bias, patients will function as their own controls by receiving alternating treatments at home and in the outpatient clinic. To participate, patients must be scheduled for SC daratumumab alone or in combination with other drugs not necessitating outpatient visits on days of planned SC daratumumab self-administration. Patients can be included and trained during cycle 1 and 2, but only treatments administered in cycle 3-6 are considered protocol treatments. Here, patients will receive SC daratumumab once every second week with treatments at day 1 administered in the outpatient clinic and treatments at day 15 administered at home. From cycle 7 onwards, patients continues SC daratumumab outside protocol according to local standards.
At inclusion, baseline demographic and clinical data should be registered for included patients. For each SC daratumumab administration in the protocol, planned treatment location (home/hospital) should be registered together with information on whether the dose was administered as planned. For each protocol treatment, regardless of treatment location, patients, caregivers, and healthcare professionals should register their time spent. In addition, patients should complete the Health Literacy Questionnaire (HLQ) and caregivers are to complete the Caregiver Roles and Responsibilities Scale (CRRS). Throughout the study, patient will also register all unplanned contacts to the healthcare system. Patient will also be asked to complete an evaluation form. Lastly, qualitative evaluations of the experience of self-administration will be conducted through semi-structured interviews with patients and caregivers, as well as focus group interviews with involved healthcare professionals.
详细描述
Introduction Subcutaneous (SC) daratumumab has significantly improved outcomes for patients with multiple myeloma (MM), allowing for longer survival with continuous treatment. However, this has also increased the burden on outpatient clinics. Future demographic shifts-more elderly and fewer healthcare workers-will only worsen the situation. For patients, ongoing treatment often means long, tiring trips to the hospital and increased infection risks. Home treatment may solve these issues.
Previous studies have shown that SC daratumumab administered at home by healthcare staff is safe and convenient, and that patients-even elderly ones-can successfully self-administer SC medications like bortezomib. In Denmark, some hospitals already offer self-administration of SC daratumumab, but without systematic data collection.
This study aims to evaluate the feasibility, safety, efficiency, and cost-effectiveness of home-based, self-administered SC daratumumab within a structured, prospective framework.
Background
Target Population:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with MM
- •Initiating treatment with SC daratumumab
- •Able to read and understand the Danish language
- •Are considered suitable for self-administration of SC daratumumab at home (in the opinion of the healthcare professional)
- •Willing and able to complete questionnaires and participate in an interview
排除标准
- •Resident on an unbridged island
- •Receiving co-treatment with other anti-myeloma treatments necessitating hospitals visits on days of home administration
- •Anything related to their ability to self-administer SC daratumumab at home e.g. physical inabilities or cognitive impairment
研究组 & 干预措施
Self-administration of SC daratumumab by the patient at their own home
The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. To reduce potential bias, patients will function as their own controls by receiving alternating treatments at home and in the outpatient clinic.
干预措施: The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. (Drug)
结局指标
主要结局
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
时间窗: 12 months
* Number of doses given unplanned/outside indication * Number of doses administered as planned at home and at the hospital
次要结局
- To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes(12 months)
- To evaluate costs related to self-administration of SC daratumumab in the patients' home compared to traditional administration at the outpatient clinic(12 months)
- To evaluate the safety of self-administration of SC daratumumab in the patients' home(12 month)
- To evaluate patients' satisfaction with self-administration of SC daratumumab(12 months)
- Perspectives on treatment at home of patients, caregivers, and healthcare staff(14 months)