Status:
RECRUITING
Self-administration of Subcutaneous Elranatamab in the Patients' Homes.
Lead Sponsor:
Thomas Lund
Collaborating Sponsors:
Pfizer
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 w...
Detailed Description
Background Bispecific antibodies targeting CD3 and BCMA have demonstrated astonishing efficacy with response rates of nearly 65 % in triple class exposed patients with multiple myeloma (MM). This will...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06015542
Start Date
January 29 2025
End Date
July 1 2027
Last Update
March 5 2025
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000