💬In plain words
What the trial is, and whether it could suit you
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 El
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 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.
Exclusion Criteria:
* Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study.
* Prior history of ICANS.
* 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
* Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or clinically significant Amyloidosis.
* Female who is pregnant, breastfeeding or who intends to become pregnant during the participation in the study.
* Positivity for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C.
* Resident on an unbridged island.
* Not being able to register PRO-data electronically.
Odense University Hospital
Odense, Denmark
Department of Heamatology
Vejle, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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