Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting..
- Кому может быть актуально
- Состояния в реестре: Multiple Myeloma in Relapse. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
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- Следующий шаг
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Официальное название
Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study
Обзор
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.
Подробное описание
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:
MM is the second most common hematologic cancer, with \~350 new cases annually in Denmark. The median age at diagnosis is 69, and \~30% are of working age. Survival has doubled over the past 20 years, but the disease remains incurable and requires lifelong treatment.
Daratumumab Treatment:
Daratumumab, a key anti-CD38 antibody in MM treatment, was originally IV but is now available as SC, enabling administration outside the hospital.
Home-Based Treatment:
Home administration reduces infection risk and travel burden-particularly important during the COVID-19 era. Studies show improved quality of life (QoL) and reduced healthcare costs (up to 50%) with self-administration. Given workforce shortages in healthcare, shifting eligible treatments to the home may help relieve system pressure.
Risk and Benefit Assessment SC daratumumab is well-established, with a known safety profile. The only change in this study is shifting administration from healthcare professionals to patients. Potential risks (e.g. incorrect administration) are mitigated through a structured training program, written instructions, and continuous support. Benefits include greater autonomy, fewer hospital visits, and resource savings. The study is considered low-risk and ethically justified.
Study Population 50 MM patients scheduled for SC daratumumab treatment and considered eligible for self-administration.
Interview Sampling:
15 patients with caregivers and 2-3 healthcare professionals per site.
Study Design and Procedures A phase IV, multicenter, prospective, non-randomized feasibility study using mixed methods. Patients will alternate between outpatient (day 1) and home (day 15) treatment during cycles 3-6.
Patients will be trained by nurses using standardized materials until they and the nurse agree the patient is confident in self-administration.
Study Treatment SC daratumumab will be administered according to national guidelines. During cycles 3-6, patients will receive treatment on day 1 in clinic and self-administer at home on day 15. Medication and instructions will be provided at the clinic. Before each home administration, a nurse will confirm eligibility via phone.
Вмешательства
- Препарат The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting.
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.
Первичные конечные точки
- To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes [Срок оценки: 12 months]
Вторичные конечные точки (7)
- To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes [Срок оценки: 12 months]
- To evaluate the safety of self-administration of SC daratumumab in the patients' home [Срок оценки: 12 month]
- To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes [Срок оценки: 12 months]
- To evaluate costs related to self-administration of SC daratumumab in the patients' home compared to traditional administration at the outpatient clinic [Срок оценки: 12 months]
- To evaluate patients' satisfaction with self-administration of SC daratumumab [Срок оценки: 12 months]
- Perspectives on treatment at home of patients, caregivers, and healthcare staff [Срок оценки: 14 months]
- To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes [Срок оценки: 12 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07191379 · SCILLA