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Study on Linvoseltamab and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Have Not Yet Received Treatment

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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 new treatment called Linvoseltamab, also known by its code name REGN5458. Linvoseltamab is a special type of medication known as a bispecific antibody, which is designed to target and attack cancer cells. The trial will also use another medication called Dexamethasone, which is a corticosteroid that helps reduce inflammation and can support cancer treatment.

The purpose of this study is to learn if Linvoseltamab is safe and well-tolerated, and to see how well it works in people who have recently been diagnosed with Multiple Myeloma and have not yet received treatment. The study is divided into two phases. In the first phase, researchers will focus on understanding the safety and best dose of Linvoseltamab. In the second phase, they will look at how effective the treatment is in reducing the cancer in patients who are eligible for high-dose chemotherapy and stem cell transplantation, as well as those who are not eligible for these procedures.

Participants in the study will receive Linvoseltamab either through an injection or infusion, and Dexamethasone will be given in tablet form or as an injection. The study will last for a period of up to two years, during which time participants will be closely monitored for any side effects and to assess how well the treatment is working. The goal is to find out if Linvoseltamab can help improve the condition of patients with Multiple Myeloma and to gather important information that could lead to new treatment options in the future.

The research process

The trial runs in 6 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, including age, health status, and a confirmed diagnosis of multiple myeloma.
No prior therapy for multiple myeloma is allowed, except for certain exceptions like short-term corticosteroids.
Step 2
Phase 1: initial treatment
The initial phase focuses on assessing the safety and tolerability of linvoseltamab, a medication administered either intravenously or subcutaneously.
The goal is to determine the appropriate dosage for the next phase of the study.
Step 3
Medication administration
Dexamethasone is administered orally as a solution for injection.
Linvoseltamab is given as a solution for infusion, either intravenously or subcutaneously.
Step 4
Phase 2: treatment evaluation
This phase evaluates the effectiveness of linvoseltamab in treating multiple myeloma.
Participants are divided into groups based on their eligibility for high-dose chemotherapy and stem cell transplantation.
Step 5
Monitoring and assessment
Throughout the trial, the incidence and severity of any adverse effects are closely monitored.
The response to treatment is measured using specific criteria to determine the effectiveness of the medication.
Step 6
Completion of the trial
The trial is expected to conclude by June 2025, with ongoing assessments of the participants' health and response to treatment.
Final results will help determine the future use of linvoseltamab in treating multiple myeloma.

Who can join the trial?

6 criteria

Have an ECOG performance status of 0, 1, or 2. This is a scale that measures how well you can perform daily activities.
Have a confirmed diagnosis of symptomatic multiple myeloma according to specific medical criteria.
Have a measurable disease based on certain medical guidelines.
Have not received prior therapy for multiple myeloma, except for emergency or comfort care radiation and up to one month of a single type of steroid medication, with specific waiting periods as outlined in the study.
Show evidence of having enough healthy bone marrow and proper liver, kidney, and heart function as defined in the study.
Be under 70 years old and have adequate liver, kidney, lung, and heart function to be considered eligible for a transplant, based on specific medical standards.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer other than Multiple Myeloma.
Patients who are not eligible for high dose chemotherapy with autologous stem cell transplantation (ASCT). This means they cannot receive a treatment where their own stem cells are used to help recover from high dose chemotherapy.
Patients who are not newly diagnosed with Multiple Myeloma.
Patients who are not within the specified age range 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

Assistance Publique Hopitaux De Paris
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Paris, France
Centre Hospitalier Universitaire De Lille
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Lille, France
Centre Hospitalier Universitaire De Montpellier
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Montpellier, France

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Investigated drugs

Linvoseltamab is a bispecific antibody designed to target two specific proteins: BCMA and CD3. It is being studied for its potential to treat patients with multiple myeloma, a type of blood cancer. The medication works by engaging the body's immune system to attack and destroy cancer cells. In this clinical trial, researchers are evaluating the safety and effectiveness of linvoseltamab in patients who have not received prior treatment for their multiple myeloma. The study aims to determine the best dose for future research and to see how well the medication can reduce or eliminate cancer in these patients.

What is already known about the treatment

Linvoseltamab – Linvoseltamab is administered as an intravenous infusion, designed for patients with multiple myeloma. It is currently in clinical trials, specifically in Phase 1/2, to evaluate its safety and effectiveness. The main therapeutic indication for linvoseltamab is multiple myeloma, a type of blood cancer. It works by targeting two proteins, BCMA and CD3, to help the immune system recognize and attack cancer cells. Linvoseltamab is classified as a bispecific antibody, which means it can bind to two different targets at the same time.

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. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to bone damage, anemia, and increased risk of infections. As the disease progresses, it can cause bone pain, fractures, and kidney problems due to the accumulation of abnormal proteins produced by the cancerous cells. The disease often develops slowly and may not show symptoms initially, but over time, it can lead to significant health issues. It is typically diagnosed through blood tests, bone marrow examination, and imaging studies.