Multiple Myeloma in RelapsePhase 4SCILLANCT07191379
Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma
A Phase 4 study testing The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. in people with Multiple Myeloma in Relapse, run by Odense University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma in Relapse
- What is being tested?
- The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma in Relapse
- Being tested
- The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting.
- Keywords
- Treatment at home, Daratumumab, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-administration of SC daratumumab by the patient at their own home | Experimental | 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. Receives: Drug: The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (7)
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
- Number of discarded doses
Measured: 12 months
To evaluate the safety of self-administration of SC daratumumab in the patients' home
- numbers of unexpected serious adverse events
Measured: 12 month
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
Measured: 12 months
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
Measured: 12 months
To evaluate patients' satisfaction with self-administration of SC daratumumab
Satisfaction scores collected via patient-reported outcomes (PRO)
Measured: 12 months
Perspectives on treatment at home of patients, caregivers, and healthcare staff
Semi-structured joint interviews with patients and their caregivers after completing the four treatment cycles under protocol defined conditions and a focus group interviews with involved healthcare professionals at end of study.
Measured: 14 months
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
- Reasons for discarding doses
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Nov 2026 (estimated)
- Primary completion29 Jun 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It is a feasibility study assessing the feasibility and safety of self-administration of SC daratumumab in the homes of the patients. 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Lund, MD, Principal investigator, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191379
- Sponsor's protocol ID
- SCILLA
- Acronym
- SCILLA
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not mandatory.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study
- ClinicalTrials.gov ID
- NCT07191379
- Acronym / sponsor ID
- SCILLA / SCILLA
- Conditions
- Multiple Myeloma in Relapse
- Keywords
- Treatment at home, Daratumumab, Multiple Myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a feasibility study assessing the feasibility and safety of self-administration of SC daratumumab in the homes of the patients. 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
| Arm | Type | Receives |
|---|---|---|
| Self-administration of SC daratumumab by the patient at their own home | Experimental | Drug: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Self-administration of SC daratumumab by the patient at their own home |
Primary outcome
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
Time frame: 12 months
* Number of doses given unplanned/outside indication * Number of doses administered as planned at home and at the hospital
7 secondary outcomes
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
Time frame: 12 months
To evaluate the safety of self-administration of SC daratumumab in the patients' home
Time frame: 12 month
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
Time frame: 12 months
To evaluate costs related to self-administration of SC daratumumab in the patients' home compared to traditional administration at the outpatient clinic
Time frame: 12 months
To evaluate patients' satisfaction with self-administration of SC daratumumab
Time frame: 12 months
Perspectives on treatment at home of patients, caregivers, and healthcare staff
Time frame: 14 months
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Not mandatory.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Lund, MD principal investigator
Vejle Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. in people with Multiple Myeloma in Relapse, run by Odense University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jannie Kirkegaard, RN (+45 29648494, Jannie.kirkegaard@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.