NCT06015542RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 Aug 2023
- Start date
- 29 Jan 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Thomas Lund
- Diseases
- Multiple myeloma
- NCT number
- NCT06015542
- EU CT number
- 2023-507876-30-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 29 Jan 2025 to the primary completion date, 1 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of ICANS.
Other illness
- 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.
Lab values
- Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study.
Age
- 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
Other
- 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.
Who the study is looking for
- ≥ 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Sygehus Lillebaelt - Vejle Sygehus Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.