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Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma

NCT07191379 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-24

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Thomas Lund, MD · Vejle Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-12-31
Completion
2027-06-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191379 on ClinicalTrials.gov