Self-administration of Subcutaneous Elranatamab in the Patients' Homes.
This study tests whether patients with relapsed multiple myeloma can safely inject elranatamab themselves at home instead of going to a clinic. Elranatamab is a cancer treatment that helps the immune system fight myeloma cells.
Key Objective:The trial investigates whether at-home self-injection of elranatamab is safe and effective, potentially improving convenience and quality of life for patients.
Who to Consider:Patients with relapsed multiple myeloma who have previously been treated with at least one proteasome inhibitor, one IMID, and one anti-CD therapy should consider enrolling.
Trial Parameters
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Brief 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 Criteria
Inclusion criteria * ≥ 18 years of age at the time of signing the informed consent form. * Relapsed MM according to the IMWG criteria. * Measurable disease defined as: M-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) and/or Serum free light chain (FLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in patients without measurable disease in the serum or urine. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2. * Previously exposed to at least two of the following; one proteasome inhibitor, one IMID, or one anti CD-38 antibody. * Documented disease progression during or after last anti-myeloma regimen. * Possibility of being observed by a capable caregiver during self-administration. * ANC ≥1.0 x 109/L (G-CSF allowed). * Platelets ≥25 x 109/L. * Female patients of childbearing potential must have a negative s