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Study on Early Treatment with Teclistamab and Talquetamab for Patients with Newly Diagnosed High-Risk Multiple Myeloma

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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 condition called Multiple Myeloma, which is a type of cancer that affects the blood. The study is exploring the use of new treatments called bispecific T-cell redirectors, specifically teclistamab and talquetamab. These treatments are designed to help the body's immune system target and fight the cancer cells more effectively. The trial also involves other medications such as dexamethasone, lenalidomide, daratumumab, and bortezomib, which are commonly used in treating multiple myeloma.

The purpose of this study is to evaluate how well these treatments work when given early in the treatment process for patients who have been newly diagnosed with high-risk multiple myeloma. The study will involve a series of treatment cycles, where patients will receive the medications either as tablets, capsules, or injections. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study will monitor the patients' responses to the treatments over time, looking for improvements in their condition.

Participants in the study will undergo regular check-ups and tests to assess their health and the effectiveness of the treatments. These tests may include scans and blood tests to measure the presence of cancer cells and the body's response to the treatment. The study aims to provide valuable information on the potential benefits of using these new treatments early in the course of the disease, which could lead to better outcomes for patients with 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
Initial treatment phase
The initial treatment phase involves the administration of medications to address multiple myeloma. This phase includes the use of teclistamab and talquetamab, which are given as subcutaneous injections. The specific dosages and frequency will be determined by the healthcare provider based on individual patient needs.
Step 2
Intensification phase
During the intensification phase, additional medications such as daratumumab are introduced. This medication is also administered via subcutaneous injection. The goal of this phase is to enhance the treatment's effectiveness.
Step 3
Maintenance phase
In the maintenance phase, the treatment continues with a focus on sustaining the achieved response. Medications like lenalidomide are taken orally. The duration and dosage are tailored to the patient's condition and response to previous treatments.
Step 4
Monitoring and evaluation
Throughout the trial, regular monitoring and evaluation are conducted to assess the treatment's effectiveness and any side effects. This includes various tests and scans to measure the disease's status and the patient's overall health.
Step 5
Completion of trial
Upon completion of the trial, a final assessment is performed to determine the overall outcomes of the treatment. This includes evaluating the patient's response to the medications and any long-term effects.

Who can join the trial?

18 criteria

The patient must be willing and able to follow the study's rules and requirements.
A woman who can have children must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
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A woman must either not be able to have children or, if she can, she must:
- Practice complete abstinence (not having sex), or
- Have a partner who has had a vasectomy (a procedure to prevent sperm from being in the semen), or
- Use two methods of birth control, with at least one being highly effective.
- A female patient must agree not to donate eggs or freeze them for future use during the study and for 3 months after the last dose of the study treatment.
- A male patient must wear a condom during any activity that could result in pregnancy during the study and for at least 3 months after the last dose of the study treatment. It is also advised that their female partner use a highly effective birth control method.
- A male patient must agree not to donate sperm during the study and for at least 3 months after the last dose of the study treatment.
- The patient must be willing and able to follow the lifestyle restrictions mentioned in the study protocol.
- Any side effects from previous treatments must be mild (Grade 1 or less) at the time of joining the study, except for hair loss.
- The patient must provide written consent to participate in the study, understanding that they can withdraw at any time without affecting their future medical care.
- The patient must be at least 18 years old at the time of giving consent.
- The patient must have a confirmed diagnosis of **Multiple Myeloma** with at least one high-risk feature, such as specific genetic changes, a high-risk disease stage, or disease outside the bone marrow.
- The patient must have measurable disease, which means certain levels of specific proteins in the blood or urine.
- Patients with **HIV** can participate if they have no detectable virus, a certain level of immune cells, no recent serious infections, and are on stable treatment for HIV.
- Patients eligible for a transplant must be 70 years old or younger, or if not eligible for a transplant, they must have a low frailty score.
- The patient must have a performance status of 0, 1, or 2, which indicates their ability to perform daily activities.
- The patient must have adequate organ function, which includes specific levels of blood cells, liver enzymes, kidney function, and calcium in the blood.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that could interfere with the study.
Patients who have had a different type of cancer in the past, unless it was treated and cured a long time ago.
Patients who are currently pregnant or breastfeeding.
Patients who have had an organ transplant.
Patients who are taking certain medications that might affect the study results.
Patients who have an active infection that requires treatment.
Patients who have a history of allergic reactions to the study drugs.
Patients who have participated in another clinical trial recently.
Patients who have a condition that affects their immune system, making it weaker.
Patients who have a history of drug or alcohol abuse.

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Verified sites

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

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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario De Navarra
Pamplona, Spain

Trial locations

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Investigated drugs

Teclistamab
is a medication used in this trial to help the immune system target and destroy cancer cells in patients with high-risk multiple myeloma. It works by redirecting T-cells, which are a type of white blood cell, to attack the cancer cells more effectively.
Talquetamab
is another medication involved in the trial, similar to Teclistamab, that also helps the immune system target multiple myeloma cells. It is designed to enhance the body's natural ability to fight the cancer by directing T-cells to the cancerous cells.
Daratumumab
is a medication used in combination with Teclistamab in this study. It is an antibody that attaches to a specific protein on the surface of multiple myeloma cells, helping the immune system to identify and destroy these cancer cells.

What is already known about the treatment

Teclistamab
Teclistamab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. It is a bispecific T-cell redirector, which means it helps the immune system target and destroy cancer cells by connecting T-cells to the cancer cells. This medication is still under investigation, and its use is primarily within clinical research settings. It falls under the pharmacological classification of immunotherapy agents.
Talquetamab
Talquetamab is given through injection and is being explored in clinical trials for its potential to treat multiple myeloma. Like Teclistamab, it is a bispecific T-cell redirector, designed to guide the body's immune cells to attack and eliminate cancer cells. This drug is in the experimental phase and is not yet widely available outside of clinical studies. It is classified as an immunotherapy agent.

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 lead to symptoms such as bone pain, frequent infections, anemia, and kidney problems. The accumulation of these abnormal cells can form tumors in the bone, known as plasmacytomas, and can also lead to a decrease in the production of normal blood cells. Over time, the disease can cause significant damage to the bones and other organs, impacting the overall health and quality of life of the affected individual.