ELRANATAMAB for Multiple myeloma

Inclusion criteria

• {"criterion_text":"- ≥ 18 years of age at the time of signing the informed consent form\n- Platelets ≥25 x 109/L\n- 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.\n- Able to read and understand the Danish language\n- Relapsed MM according to the IMWG criteria\n- 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\n- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2\n- Previously exposed to at least two of the following: one proteasome inhibitor, one Immunomodulatory drugs (IMID), or one anti CD-38 antibody\n- Documented disease progression during or after last anti-myeloma regimen\n- Possibility of being observed by a capable caregiver during self-administration, to react appropriately if necessary\n- ANC ≥1.0 x 109/L (G-CSF allowed)"}

Exclusion criteria

• {"criterion_text":"- Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study\n- Prior BCMA targeted treatment\n- Prior history of ICANS\n- 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\n- Plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes), or clinically significant Amyloidosis\n- Female who is pregnant, breastfeeding, or who intends to become pregnant during the participation in the study\n- Positivity for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C\n- Resident on an unbridged island"}

Primary endpoints

• {"endpoint_text":"- Number of discarded doses, planned doses administered at home, and doses diverted from the patients’ homes to the outpatient clinic evaluated at EoP1\n- Incidence and severity of AEs and SAEs evaluated at EoP1. AEs/SAEs will be graded according to NCI CTCAE v5.0. CRS and ICANS will be graded according to ASTCT consensus grading","definition_or_measurement_approach":"First primary endpoint: evaluated at EoP1. Second primary endpoint: AEs/SAEs graded according to NCI CTCAE v5.0; CRS and ICANS graded according to ASTCT consensus grading; evaluated at EoP1."}

Secondary endpoints

• {"endpoint_text":"- Number of infections requiring medical attention or hospitalization assessed at EoP1\n- Incidence and severity of AEs and SAEs evaluated at EoP2. AEs/SAEs will be graded according to NCI CTCAE v5.0. CRS and ICANS will be graded according to ASTCT consensus grading\n- Overall Response Rate (ORR) and duration of response at EoP2 with response defined according to IMWG response criteria\n- PPV and NPV of self-reporting of side effects assessed at EoP1\n- Time consumption for patients, caregivers, and healthcare professionals assessed at EoP1\n- Number of unplanned contacts to the healthcare system assessed at EoP1\n- Number of patients reporting improved or impaired quality of life at C3D1 and EoP1 compared to baseline using the EORTC QLQ-C30 and MY20\n- Number of patients developing cognitive impairment during elranatamab treatment assessed at EoP1 by the FACT-Cog domain of perceived cognitive impairments\n- Number of patients developing perceived cognitive impairment, who recover from perceived cognitive impairment based on the following FACT-Cog assessments assessed at EoP1\n- Number of caregivers experiencing their quality of life to be affected to a higher degree at C3D1 and EoP1 compared to baseline assessed by FROM-16","definition_or_measurement_approach":"Each secondary endpoint includes the specified timepoint(s): assessed at EoP1 or EoP2 or C3D1 as indicated in the endpoint text; AE/SAE grading per NCI CTCAE v5.0; CRS and ICANS per ASTCT consensus grading; ORR per IMWG response criteria; QoL measures using EORTC QLQ-C30 and MY20; cognitive function using FACT-Cog; caregiver QoL using FROM-16."}

Denmark

Earliest CTIS Part Ii Submission Date

28-06-2024

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

584

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"codes: 1,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}