Self-administration of subcutaneous Elranatamab in the patients’ homes (ERICA) - An open label, phase two, prospective, non-randomized, sponsor-initiated single center feasibility study

Odense University Hospital0 个研究点目标入组 20 人开始时间: 2024年3月19日最近更新: 2024年7月22日

适应症

试验速览

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•= 18 years of age at the time of signing the informed consent form, 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., Able to read and understand the Danish language, 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 (?/?) ratio in patients, Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2, Previously exposed to at least one proteasome inhibitor, one Immunomodulatory drugs (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, to react appropriately if necessary, ANC =1.0 x 109/L (G-CSF allowed)

•Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study, Prior BCMA targeted treatment, 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

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