Self-administration of Subcutaneous Elranatamab in the Patients' Homes. (ERICA)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
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 one proteasome inhibitor, one IMID and 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.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Self-administration of Elranatamab
It is a feasibility study assessing the feasibility and safety of self-administration of Elranatamab in the homes of the patients. The intervention of the study is self-administration of Elranatamab by the patient, thereby changing the administration from an outpatient setting to a home setting. The patients will function as their own controls, as treatment will be given alternately at home and in the outpatient clinic.