Self-administration of Subcutaneous Elranatamab in the Patients' Homes.

Sponsor
Thomas Lund
Study ID
NCT06015542
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elranatamab — DRUG
    Elranatamab will be administered as monotherapy for six cycles of 28 days. Elranatamab 76 mg will be administered QW with a 2-step-up priming dose regimen administered during the first week (12 mg D1 and 32 mg D4).

Study Details

The goal of this open label, phase two, prospective, non-randomized, sponsor-initiated explorative trial is to test self-administration of subcutaneous Elranatamab in the patients' homes in patients with relapsed multiple myeloma exposed to at least one proteasome inhibitor, one IMID and one anti CD-38 antibody. The main question\[s\]it aims to answer are: * To evaluate the safety of self-administration of Elranatamab in the patients' own homes using registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections. * To evaluate the feasibility of self-administration of Elranatamab in the patients´ own homes by registration of discarded doses, planned doses administered at home and doses diverted from the patients' homes to the outpatient clinic. * To elucidate the perspectives of patients and their caregivers of self-administration of Elranatamab at home by interviewing both parties at end of treatment (EOT). * To elucidate the perspectives of involved healthcare professionals in a focus group interview at end of study (EOS). * To clarify time spent on self-administration at home compared to administration at the outpatient clinic by registering time consumption for patients, caregivers and healthcare professionals. * To evaluate the patients' QoL during self-administration using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) together with the Functional Assessment of Cancer Therapy-Cognitive (FACT Cognitive). * To clarify if self-administration in the patients' homes leads to additional unplanned contacts with the healthcare system as a whole by weekly registration of any unplanned contacts. * To determine financial costs of self-administration at home compared to administration at the outpatient clinic from the perspectives of patients, caregivers and the healthcare system by collecting data on lost earnings, transport costs and salary costs. * To evaluate the feasibility of the use of an electronic registration of side effects prior to treatment by comparing electronic patient reported outcome (PRO) data to registrations performed by nurses in the outpatient clinic during telephone consultations. Participants will be asked to * register time spend * answer PRO-questionnaires * weekly register any unplanned contact to the heathcare system * be interviewed

Key Dates

Start date
Jan 29, 2025
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Self-administration of Elranatamab
    It is a feasibility study assessing the feasibility and safety of self-administration of Elranatamab in the homes of the patients. The intervention of the study is self-administration of Elranatamab by the patient, thereby changing the administration from an outpatient setting to a home setting. The patients will function as their own controls, as treatment will be given alternately at home and in the outpatient clinic.

Primary Outcome Measure

Evaluate the safety of self-administration of Elranatamab in the patients' own homes assessed by checklist [ Time Frame: approximately 24 weeks ]

Central Contacts

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