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.
