Not recruiting

Study of Talquetamab and Teclistamab for Patients with Relapsed or Refractory Multiple Myeloma

Verified siteRegistered drugNo 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 condition called Multiple Myeloma, which is a type of cancer that affects the blood. The study is testing a combination of two treatments, Talquetamab and Teclistamab, both of which are given as injections under the skin. These treatments are known as bispecific T cell redirection antibodies, which are designed to help the body's immune system target and fight cancer cells more effectively.

The purpose of the study is to find the best dose and schedule for these treatments, to understand their safety, and to see how well they work in people whose Multiple Myeloma has returned or has not responded to previous treatments. The study is divided into different parts, each focusing on different aspects of the treatment, such as determining the right dose and evaluating the safety and effectiveness of the treatment combination.

Participants in the study will receive either the combination of Talquetamab and Teclistamab or a placebo. The study will monitor the participants over time to assess any side effects and to measure how the cancer responds to the treatment. The study is expected to continue until December 2025, providing valuable information on the potential benefits and risks of these new treatments for Multiple Myeloma.

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, the patient is confirmed to have a diagnosis of multiple myeloma according to specific criteria.
The patient must have a history of disease that is either relapsed or refractory to previous treatments.
Step 2
Initial assessment
An initial assessment is conducted to determine the patient's performance status, which should be within a specific range to proceed with the study.
Step 3
Treatment phase 1
The patient receives a combination of talquetamab and teclistamab, both administered as a solution for injection under the skin.
The objective is to identify the appropriate dosage and schedule for these medications.
Step 4
Treatment phase 2
The focus is on assessing the safety of the identified dosage and schedule from phase 1.
The patient continues to receive the same medications as in phase 1.
Step 5
Treatment phase 3
The patient continues to receive talquetamab and teclistamab to evaluate their effectiveness against the cancer.
The patient may also receive daratumumab as part of the treatment, administered as a solution for injection under the skin.
Step 6
Monitoring and follow-up
Throughout the study, the patient is monitored for any side effects or adverse reactions to the medications.
Regular assessments are conducted to evaluate the patient's response to the treatment.

Who can join the trial?

7 criteria

The patient must have a documented initial diagnosis of multiple myeloma, which is a type of blood cancer, according to specific medical guidelines.
For Parts 1 and 2 of the study, the patient must have a disease that has come back or not responded to standard treatments, including the most recent treatment they received.
For Part 3 of the study, the patient must have a disease that has come back or not responded to treatment and must have been treated with a PI (proteasome inhibitor), IMiD (immunomodulatory drug), and an anti-CD38 mAb (a type of antibody therapy).
The patient must have documented evidence that their disease is getting worse, as determined by a doctor using specific criteria, after their last treatment.
For Parts 1 and 2, the patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed. For Part 3, the patient can have an ECOG performance status of 0, 1, or 2, which means they are fully active, have some symptoms, or are unable to work but can take care of themselves.
The study is open to both male and female patients.
The study includes patients who may be considered vulnerable, meaning they might need extra protection or care.

Who cannot join the trial?

8 criteria

Patients with other types of cancer besides Multiple Myeloma cannot participate.
Patients who have not experienced a return or worsening of their Multiple Myeloma after treatment are excluded.
Patients with serious health conditions that could interfere with the study treatment are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or attend scheduled visits are excluded.
Patients who have participated in another clinical trial within a certain time frame before this study are not eligible.
Patients with known allergies to the study medications or similar drugs cannot participate.
Patients with certain infections or diseases that could affect the study results are excluded.

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Verified sites

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

Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Verified
Hospital Universitario De Navarra
Pamplona, Spain
Verified
Hospital Universitario De Salamanca
Salamanca, Spain

Trial locations

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Investigated drugs

Talquetamab
is a bispecific T cell redirection antibody being studied for its potential to treat relapsed or refractory multiple myeloma. It works by engaging the body's immune system, specifically T cells, to target and destroy cancer cells.
Teclistamab
is another bispecific T cell redirection antibody used in combination with Talquetamab in this study. It also aims to harness the immune system to fight against multiple myeloma by directing T cells to attack the cancerous cells.

What is already known about the treatment

Talquetamab
This medication 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 in the investigational stage, meaning it is not yet approved for general medical use. Talquetamab works by redirecting T cells, a type of immune cell, to target and destroy cancer cells. It belongs to a class of drugs known as bispecific T cell redirection antibodies.
Teclistamab
This medication is also administered via injection and is under investigation in clinical trials for the treatment of multiple myeloma. Like Talquetamab, it is not yet approved for widespread medical use. Teclistamab functions by engaging T cells to attack and eliminate cancer cells, utilizing a similar mechanism as Talquetamab. It is classified as a bispecific T cell redirection antibody.

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 and other organs. As the disease progresses, it can result in bone pain, fractures, and anemia due to the crowding out of normal blood cells. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses in a series of relapses and remissions, with symptoms worsening over time.