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.
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)
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
Single group
The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting.
DrugThe 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 evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
* Number of doses given unplanned/outside indication * Number of doses administered as planned at home and at the hospital
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
\- Number of discarded doses
To evaluate the safety of self-administration of SC daratumumab in the patients' home
\- numbers of unexpected serious adverse events
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
* Number of patients willing to participate, dropping out, and/or deemed ineligible to participate * Reasons for this
To evaluate costs related to self-administration of SC daratumumab in the patients' home compared to traditional administration at the outpatient clinic
\- Time spent by patients, caregivers, and healthcare professionals administering the treatment in minutes
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