BridgeMD
Self-administration of subcutaneous Elranatamab in the patients’ homes (ERICA)
EU CTIS ID: 2023-507876-30-00
What this study is testing
To evaluate the feasibility of self-administration of Elranatamab in the patients´ homes To evaluate the safety of self-administration of Elranatamab in the patients’ homes
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 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 (κ/λ) ratio in patients
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- ≥ 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 (κ/λ) ratio in patients
- 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 Immunomodulatory drugs (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, to react appropriately if necessary
- ANC ≥1.0 x 109/L (G-CSF allowed)
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.