RecruitingPhase 2NCT06015542

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

Self-administration of Subcutaneous Elranatamab in the Patients' Homes. An Open Label, Phase Two, Prospective, Multi-center, Non-randomized, Sponsor-initiated Explorative Trial


Sponsor

Thomas Lund

Enrollment

20 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether patients with relapsed multiple myeloma (a blood cancer) can safely and effectively self-administer their elranatamab injections at home (under the skin), rather than coming to a clinic each time. It focuses on convenience and patient independence for people already responding to this treatment. **You may be eligible if...** - You are 18 or older - You have relapsed multiple myeloma confirmed by standard criteria - Your myeloma shows measurable disease markers in blood or urine - You have previously received at least two of the following: a proteasome inhibitor, an immunomodulatory drug (IMiD), or an anti-CD38 antibody - Your cancer progressed on or after your last treatment - You are in reasonably good health (ECOG 0–2) - You have a capable caregiver present when you self-inject - Your blood counts meet minimum thresholds **You may NOT be eligible if...** - You have a serious medical condition, lab abnormality, or psychiatric illness that would prevent safe participation - You have a prior history of immune effector cell-associated neurotoxicity syndrome (ICANS) - You are pregnant or breastfeeding without using effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGElranatamab

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).


Locations(2)

Odense University Hospital

Odense, Denmark

Department of Heamatology

Vejle, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06015542


Related Trials