Self-administration of Elranatamab for multiple myeloma at home

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Jannie.kirkegaard@rsyd.dk
• Phone: +45 29648494

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Elranatamab given as outpatient in relapsed or refractory multiple myeloma

  This study tests a bispecific antibody called elranatamab, given in an outpatient setting to adults with relapsed or refractory multiple myeloma who have had prior therapies.

  Recruiting at 6 sites Phase 2 SCRI Development Innovations, LLC · Denver, Colorado and 5 other locations · NCT07637578

• Elranatamab plus cyclophosphamide for relapsed/refractory multiple myeloma with high-risk features

  This will test whether adding cyclophosphamide to elranatamab helps people with relapsed or refractory multiple myeloma who have risk factors that might make elranatamab alone less effective.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07454382

• Elranatamab with lenalidomide and dexamethasone for newly diagnosed multiple myeloma.

  This trial will test whether adding elranatamab to lenalidomide and dexamethasone helps people newly diagnosed with multiple myeloma.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT06997081

• Mezigdomide plus elranatamab for relapsed or refractory multiple myeloma

  This test tries adding mezigdomide to elranatamab (with dexamethasone) to see if it is safe and can help adults with relapsed or refractory multiple myeloma who have had 1–4 prior treatments (eligibility differs by phase).

  Recruiting at 20 sites Phase 1/2 Celgene · Birmingham, Alabama and 21 other locations · NCT06988488

• Personalized dendritic cell–myeloma fusion vaccine combined with elranatamab for relapsed or refractory multiple myeloma

  This will try a personalized dendritic cell–myeloma fusion vaccine given with elranatamab in people with relapsed or refractory multiple myeloma.

  Recruiting at 2 sites Phase 1 Beth Israel Deaconess Medical Center · Boston, Massachusetts and 1 other locations · NCT06799026

• Evaluating elranatamab for treating relapsed or refractory multiple myeloma

  This study is testing a new treatment called elranatamab to see if it can help people with relapsed or refractory multiple myeloma who have already tried other therapies.

  Recruiting Phase 2 University of California, San Diego · La Jolla, California · NCT06711705

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.