Self-administration of Elranatamab for multiple myeloma at home

Self-administration of Subcutaneous Elranatamab in the Patients' Homes. An Open Label, Phase Two, Prospective, Multi-center, Non-randomized, Sponsor-initiated Explorative Trial

This study is testing if patients with relapsed multiple myeloma can safely give themselves a new treatment called Elranatamab at home and how it affects their quality of life.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Odense University Hospital (other)
• Drugs / interventions: Elranatamab
• Locations: 2 sites (Odense and 1 other locations)
• Trial ID: NCT06015542 on ClinicalTrials.gov

What this trial studies

This open-label, phase two trial investigates the safety and feasibility of self-administering Elranatamab, a bispecific antibody, in the homes of patients with relapsed multiple myeloma. Participants must have been previously treated with specific therapies and will be monitored for adverse effects, including cytokine release syndrome and infections. The study also aims to gather insights from patients and caregivers regarding their experiences with home administration. By allowing patients to manage their treatment at home, the trial seeks to enhance quality of life and reduce healthcare burdens.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed multiple myeloma who have been previously treated with at least one proteasome inhibitor, one IMID, and one anti CD-38 antibody.

Not a fit: Patients who have not been previously treated with the required therapies or those unable to self-administer due to health or logistical reasons may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients by allowing them to self-administer treatment in the comfort of their homes.

How similar studies have performed: Previous studies have indicated that self-administration of treatments can lead to improved quality of life and reduced healthcare costs, suggesting a positive outlook for this approach.

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 two of the following; one proteasome inhibitor, one 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.
* 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.

Where this trial is running

Odense and 1 other locations

• Odense University Hospital — Odense, Denmark (RECRUITING)
• Department of Heamatology — Vejle, Denmark (RECRUITING)

Study contacts

• Principal investigator: Thomas Lund, MD — Odense Universitetshospital
• Study coordinator: Jannie Kirkegaard, RN

Conditions: Multiple Myeloma