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

A vizsgálat adatai

Ki végzi

Thomas Lund

Azonosító

NCT06015542EU 2023-507876-30-00

A regiszteradat frissítve

2026. február 10.

Eredeti leírás

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:A teljes eredeti leírásKevesebb

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

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

Bevonási feltételek: ≥ 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 serum pregnancy test at screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

Kizáró feltételek: Prior history of ICANS; Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or clinically significant Amyloidosis; Positivity for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C; Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study; Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies:; Basal cell carcinoma of the skin; Squamous cell carcinoma of the skin; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes and metastasis] clinical staging system) or prostate cancer that is curative; Female who is pregnant, breastfeeding or who intends to become pregnant during the participation in the study; Resident on an unbridged island; Not being able to register PRO-data electronically.

ClinicalTrials.gov NCT06015542 · EU CTIS 2023-507876-30-00