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Study on Reducing Oral Side Effects of Talquetamab in Multiple Myeloma Patients Using Pregabalin, Dexamethasone, and Clonazepam

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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 plasma cells in the bone marrow. The study is investigating a treatment involving a medication known as talquetamab, which is given as a solution for injection under the skin. The purpose of the study is to find ways to prevent or reduce oral side effects, specifically taste changes, that may occur with talquetamab treatment.

Participants in the study will receive talquetamab and may also be given other treatments to help manage any taste changes. These additional treatments include Pregabalin, which is a medication often used to treat nerve pain, Dexamethasone in the form of a mouthwash, and Clonazepam, which is a tablet that dissolves in the mouth. Some participants may receive a placebo instead of these additional treatments. The study will monitor how these treatments affect the taste changes caused by talquetamab over time.

The study will take place over several months, during which participants will be regularly assessed to see how their taste changes and if it improves with the treatments provided. The goal is to better understand and manage the taste changes associated with talquetamab, making the treatment experience more comfortable for patients with multiple myeloma.

The research process

The trial runs in 4 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 participant will be informed about the trial's purpose, which is to evaluate interventions to reduce oral side effects related to the medication talquetamab.
The participant will be required to provide informed consent, acknowledging understanding of the study's procedures and potential risks.
Step 2
Treatment phase
The participant will receive talquetamab as a solution for injection, administered subcutaneously. The specific dosage and frequency will be determined by the study protocol.
Additional medications may include pregabalin (oral capsules) and dexamethasone (oral mouthwash) to manage symptoms and side effects.
The participant may also receive clonazepam in the form of orally disintegrating tablets, if necessary, to address specific symptoms.
Step 3
Monitoring and assessments
Throughout the study, the participant will undergo regular assessments to monitor the occurrence and severity of taste dysfunction, known as hypogeusia.
The participant's response to the treatment and any side effects will be closely monitored to ensure safety and effectiveness.
Step 4
Follow-up
After completing the treatment phase, the participant will continue to be monitored for any changes in symptoms or side effects.
Follow-up assessments will occur at 3 and 6 months to evaluate the resolution or improvement of hypogeusia.

Who can join the trial?

20 criteria

Must have **multiple myeloma**, a type of blood cancer, according to specific diagnostic criteria.
Must have a measurable disease, which means the disease can be detected and measured in the body through tests.
Must have been treated before with three specific types of medications: a **PI** (proteasome inhibitor), an **IMiD** (immunomodulatory drug), and an **anti-CD38 mAb** (a type of antibody).
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Must have certain blood test results within specific ranges, such as:
- **Hemoglobin**: a protein in red blood cells, must be at least 8 g/dL.
- **Platelets**: cells that help with blood clotting, must be at least 75,000 per microliter if less than 50% of bone marrow cells are plasma cells, or at least 50,000 if 50% or more are plasma cells.
- **Absolute neutrophil count**: a type of white blood cell, must be at least 1,000 per microliter.
- **AST and ALT**: liver enzymes, must be less than 3 times the upper limit of normal.
- **eGFR**: a measure of kidney function, must be at least 30 mL/min.
- **Total bilirubin**: a substance made by the liver, must be less than 1.5 times the upper limit of normal.
- **Serum calcium**: a mineral in the blood, must be within normal limits.
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  If **HIV-positive**, must meet specific conditions:
  - No detectable viral load, meaning the virus is not found in the blood.
  - **CD4+ count**: a type of white blood cell, must be more than 300 cells/mm³.
  - No serious infections related to HIV in the last 6 months.
  - Must be on **HAART**, a treatment for HIV, with no recent changes due to resistance or progression.
  - Must agree to certain conditions regarding pregnancy and contraception:
    
    Cannot be pregnant or breastfeeding.
    Cannot donate eggs or sperm.
    Must use condoms and, if of childbearing potential, have a negative pregnancy test and use effective contraception.
    If the partner is of childbearing potential, they must also use effective contraception unless the participant has had a vasectomy.
    Both men and women can participate.
    Participants must be within a certain age range, typically adults.

Who cannot join the trial?

4 criteria

Patients who do not have multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain cells in the bone marrow.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who might be at higher risk of harm or exploitation.

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Verified sites

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Verified
Albert Schweitzer Ziekenhuis
Dordrecht, The Netherlands
Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

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Investigated drugs

Talquetamab is a medication being studied for its potential to treat certain conditions. In this trial, researchers are looking at how it might cause changes in taste, known as hypogeusia. The goal is to find ways to prevent or reduce these taste changes while patients are receiving talquetamab.

What is already known about the treatment

Talquetamab – Talquetamab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials, particularly for its effects on multiple myeloma, a type of blood cancer. The medication works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

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. These cells become abnormal and multiply uncontrollably, leading to the production of abnormal proteins that can cause damage to bones and other organs. As the disease progresses, it can lead to bone pain, fractures, and anemia due to the overcrowding of healthy blood cells. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses slowly, but it can become more aggressive over time. Symptoms can vary widely among individuals, and some may not experience noticeable symptoms until the disease is advanced.