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Study on Self-Administration of Elranatamab for Patients with Multiple Myeloma at Home

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects the blood. The treatment being tested in this study is a medication called Elranatamab, which is given as an injection under the skin. The purpose of the study is to see if patients can safely and effectively give themselves this medication at home.

Participants in the study will be asked to self-administer Elranatamab at home over a period of time. The study will monitor how well patients can manage this process and will also look at the safety of doing so. This includes checking for any side effects or complications that might occur. The study aims to understand if this method of treatment can be a convenient option for patients, potentially reducing the need for frequent hospital visits.

Throughout the study, researchers will collect information on various aspects, such as the number of doses given at home, any doses that need to be given at a clinic instead, and any side effects experienced by the participants. The study will also assess how this treatment method affects the quality of life for both patients and their caregivers. The findings will help determine if self-administration of Elranatamab is a feasible and safe option for people with Multiple Myeloma.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.
Participants must be able to read and understand the Danish language and have a caregiver available during self-administration.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health conditions and to ensure all inclusion criteria are met.
Female participants of childbearing potential must undergo a pregnancy test.
Step 3
Medication administration
The medication Elranatamab is administered as a solution for injection under the skin (subcutaneous).
Participants will self-administer the medication at home, with the possibility of being observed by a caregiver.
Step 4
Monitoring and evaluation
The study evaluates the number of doses administered at home and any doses that need to be given at a clinic.
The incidence and severity of any side effects are monitored throughout the study.
Step 5
Follow-up assessments
Regular follow-up assessments are conducted to monitor the participant's response to the treatment and any side effects.
The overall response rate and duration of response are evaluated according to specific criteria.
Step 6
Quality of life evaluation
Participants' quality of life is assessed at specific points during the study using standardized questionnaires.
The impact on caregivers' quality of life is also evaluated.
Step 7
Completion of the study
The study is estimated to end by December 31, 2028.
Final assessments are conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

11 criteria

Must be 18 years or older at the time of signing the consent form.
Must have platelets (a type of blood cell) 25 x 10⁹/L or higher.
Female patients who can have children must have a negative pregnancy test at the start. Both female patients who can have children and male patients who are fertile and sexually active with such females must use highly effective birth control during the study and for 3 months after the last treatment.
Must be able to read and understand Danish.
Must have relapsed multiple myeloma according to specific criteria.
Must have a measurable disease, which means certain protein levels in the blood or urine are above specific amounts.
Must have an ECOG performance status score of 0, 1, or 2, which is a way to measure how well a person can perform daily activities.
Must have been treated with at least one proteasome inhibitor, one immunomodulatory drug (IMID), and one anti CD-38 antibody before.
Must have documented disease progression, meaning the disease got worse during or after the last treatment for multiple myeloma.
Must have the possibility of being observed by a capable caregiver during self-administration to react appropriately if needed.
Must have ANC (a type of white blood cell count) 1.0 x 10⁹/L or higher, with the help of G-CSF if needed.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with Multiple Myeloma. This is a type of cancer that affects certain cells in the bone marrow.
Patients who are not within the specified age range for the study.
Patients who do not belong to the specific clinical trial group required for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Odense University Hospital
Odense, Denmark
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Sygehus Lillebaelt Vejle Sygehus
Vejle, Denmark

Trial locations

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Investigated drugs

Elranatamab is a medication being studied for its potential use in treating certain conditions. In this clinical trial, the focus is on evaluating how feasible it is for patients to self-administer this medication at home. The study also aims to assess the safety of patients administering the medication themselves outside of a clinical setting.

Elranatamab

What is already known about the treatment

Elranatamab – Elranatamab is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials, particularly focusing on its use for patients with multiple myeloma. The main therapeutic indication for Elranatamab is the treatment of multiple myeloma, a type of blood cancer. At the molecular level, Elranatamab works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. It is classified pharmacologically as a monoclonal antibody, which is a type of protein designed to bind to specific targets in the body.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to issues such as anemia, bone damage, and kidney problems. As the disease progresses, it can cause bone pain, frequent infections, and fatigue due to the overproduction of abnormal proteins. These proteins can also lead to complications like kidney damage. The disease often progresses slowly, but it can become more aggressive over time. It is characterized by periods of remission and relapse, where symptoms may improve and then worsen again.