Condition: Multiple Myeloma · Sponsor: Thomas Lund
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 As…
This description comes directly from the study's public registry record.
Jannie Kirkegaard, RN · +45 29648494 · Jannie.kirkegaard@rsyd.dk
Tine Rosenberg, MSc · +45 21370942 · tine.rosenberg@rsyd.dk
Always discuss trial participation with your own doctor first.
| Odense University Hospital | Odense, Denmark | Recruiting |
| Department of Heamatology | Vejle, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06015542