Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma

NCT07191379 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: SCILLA
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Multiple Myeloma in Relapse

Keywords

Treatment at home; Daratumumab; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (7)

• To evaluate the feasibility of self-administration of SC daratumumab in the patients´ homes

  12 months

• To evaluate the safety of self-administration of SC daratumumab in the patients' home

  12 month

• 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 patients' satisfaction with self-administration of SC daratumumab

  12 months

Study Arms (1)

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.

Other: The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting.

Interventions

The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. OTHER

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.

Self-administration of SC daratumumab by the patient at their own home

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Thomas Lund, MD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannie Kirkegaard, RN

CONTACT

+45 29648494; Jannie.kirkegaard@rsyd.dk

Tine Rosenberg, MSc

CONTACT

+45 21370942; tine.rosenberg@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share