Not recruitingRare disease

Study of Elranatamab for Treating Relapsed or Refractory Multiple Myeloma in Patients Previously Treated with Three Drug Classes

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 plasma cells in the bone marrow. The study is testing a treatment called Elranatamab, which is given as a solution for injection under the skin. The purpose of the study is to evaluate how effective Elranatamab is in treating patients whose multiple myeloma has returned or has not responded to previous treatments.

Participants in the study will receive Elranatamab as a single treatment. The study will observe patients over a period of time to see how their disease responds to the treatment. The researchers will look at how many patients have no detectable signs of the disease at 6 and 12 months. This will help determine the effectiveness of Elranatamab in managing multiple myeloma.

The study is open-label, meaning both the researchers and participants know what treatment is being given. It is conducted at multiple centers, allowing for a broader range of participants. The study will continue until the disease progresses, the participant decides to withdraw, or the study reaches its end date. This trial aims to provide valuable information on the potential benefits of Elranatamab for patients with relapsed or refractory multiple myeloma.

The research process

The trial runs in 5 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, the patient will undergo a screening phase to ensure eligibility. This includes meeting specific health criteria and providing informed consent.
Step 2
Treatment initiation
The patient will begin treatment with elranatamab, a solution for injection administered subcutaneously. The dosage and frequency will be determined by the study protocol and the patient's condition.
Step 3
Treatment phase
During the treatment phase, the patient will receive regular doses of elranatamab. The patient's response to the treatment will be monitored closely by the study team.
Step 4
Monitoring and evaluation
The patient's health and response to the treatment will be evaluated at regular intervals. This includes assessing the rate of undetectable measurable residual disease at 6 and 12 months.
Step 5
Completion of study
The study is considered complete for the patient if they are followed until disease progression, withdrawal of consent, loss to follow-up, death, or the end of the study.

Who can join the trial?

13 criteria

Patients must have **relapsed multiple myeloma**, meaning the disease has returned after treatment, and have received 1 or 2 previous treatments.
Patients must have been treated with at least one **proteasome inhibitor** (such as bortezomib, carfilzomib, or ixazomib), one **immunomodulatory drug** (lenalidomide is required, and they may have also used pomalidomide), and at least one **anti-CD38 monoclonal antibody** (such as daratumumab or isatuximab).
Patients must have certain **blood test results** before starting the study, including specific levels of hemoglobin, neutrophils, platelets, liver enzymes (AST and ALT), bilirubin, kidney function (creatinine clearance), and calcium.
Women who can have children must use a highly effective method of **birth control** and have a negative pregnancy test before starting treatment.
Men participating in the study must agree to use contraception or remain abstinent from heterosexual intercourse during the study and for at least 100 days after.
Patients must show evidence of **progressive disease**, meaning the disease is getting worse, or have not responded to their last treatment.
Patients must have a **measurable secretory disease**, which means certain proteins in the blood or urine are at specific levels.
Participants must be **18 years or older**.
Patients must be able to follow the study's requirements, according to the investigator's opinion.
Patients must have a prior diagnosis of multiple myeloma according to specific criteria.
Patients must provide **written informed consent** to participate in the study, understanding they can withdraw at any time.
Patients must have an **ECOG performance status** of 0 or 1, which indicates they are fully active or have some symptoms but do not require bed rest.
Patients must have a **left-ventricular ejection fraction (LVEF)** of 40% or higher, which is a measure of heart function.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer other than Multiple Myeloma cannot participate.
Patients who have not experienced a return or worsening of Multiple Myeloma after treatment are excluded.
Patients who are under the age of 18 or over the age of 65 are not eligible.
Patients who are part of a vulnerable population, such as those unable to give consent, are not allowed to join the study.

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Verified sites

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

El Hospital Universitario De Gran Canaria Dr. Negrin
Verified
Las Palmas De Gran Canaria, Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain
Hospital Jerez de la Frontera
Verified
Jerez De La Frontera, Spain

Trial locations

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Investigated drugs

Elranatamab is being studied as a treatment for patients with multiple myeloma, a type of blood cancer, who have not responded to previous treatments. This medication is being tested to see how effective it is when used alone in patients who have already tried other types of cancer drugs. The goal is to determine if it can help reduce or eliminate the cancer cells in these patients.

Elranatamab

What is already known about the treatment

Elranatamab – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, particularly in patients who have not responded to other treatments. It is in the phase II stage of clinical trials, indicating that it is still under investigation but has shown promise in earlier studies. Elranatamab is primarily used for relapsed or refractory multiple myeloma, a type of blood cancer. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. Elranatamab is classified as a monoclonal antibody, a type of drug designed to interact with specific targets in the body.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells. Over time, the disease can cause significant complications, affecting various organs and systems in the body.