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Study of Selinexor, Dexamethasone, and Bortezomib for Patients with Refractory 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 blood cancer that affects plasma cells in the bone marrow. The study is specifically looking at two forms of this disease: Penta-refractory Multiple Myeloma and Triple-class Refractory Multiple Myeloma. These terms refer to cases where the disease has not responded to several previous treatments. The trial involves testing a combination of medications to see how effective they are in treating these forms of multiple myeloma.

The medications being tested include Selinexor, Dexamethasone, and Bortezomib. Selinexor is a medication that works by blocking certain proteins in cancer cells, which can help stop the cancer from growing. Dexamethasone is a type of steroid that can help reduce inflammation and is often used in cancer treatment to help manage symptoms. Bortezomib is a drug that interferes with the growth of cancer cells and is used in the treatment of multiple myeloma. The study will also use a placebo in some cases to compare the effects of the actual medications.

The purpose of this study is to evaluate how well these medications work when used together in different combinations. Participants in the study will receive one of several treatment plans, which may include different doses of Selinexor and Dexamethasone, with or without Bortezomib. The study will monitor the participants over a period of time to see how their condition responds to the treatment. This will help researchers understand the effectiveness of these drug combinations in managing 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 will be assigned to one of the treatment arms based on their specific condition of multiple myeloma.
The study involves different combinations of medications, which will be administered according to the assigned treatment arm.
Step 2
Treatment with selinexor and dexamethasone
For patients with penta-refractory multiple myeloma, treatment may include selinexor and dexamethasone.
The dosage and frequency are as follows: selinexor 40 mg plus dexamethasone 20 mg twice a week, or selinexor 80 mg plus dexamethasone 20 mg twice a week, or selinexor 100 mg plus dexamethasone 40 mg once a week.
Step 3
Treatment with selinexor, dexamethasone, and bortezomib
For patients with triple-class refractory multiple myeloma, the treatment includes selinexor, dexamethasone, and bortezomib.
The dosage is selinexor 100 mg, dexamethasone 40 mg, and bortezomib 1.3 mg/m², administered once a week, excluding the fifth week.
Step 4
Additional medications
Additional medications may include olanzapine and ondansetron, which are taken orally to manage side effects.
The specific dosage and frequency of these medications will be determined by the healthcare provider.
Step 5
Monitoring and evaluation
Throughout the trial, the patient's response to treatment will be monitored regularly.
Evaluations will include assessments of the disease's progression and any side effects experienced.
Step 6
Completion of the trial
The trial is expected to continue until January 31, 2028, or until the patient completes their participation.
Upon completion, the patient's overall response to the treatment will be assessed, and further treatment options may be discussed.

Who can join the trial?

9 criteria

Must be at least 18 years old at the time of signing the consent form.
Must sign a written consent form following federal, local, and institutional guidelines.
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Must have measurable **multiple myeloma**. This means the disease can be measured using specific tests, such as:
- Serum M-protein of at least 0.5 g/dL, which is a protein found in the blood.
- Urinary M-protein excretion of at least 200 mg in 24 hours, which is a protein found in urine.
- Free light chain (FLC) of at least 100 mg/L, with an abnormal FLC ratio. FLC are small proteins in the blood.
- For certain treatment groups, patients must have **relapsed or refractory multiple myeloma (RRMM)**, meaning the disease has returned or not responded to treatment. They must have received at least 4 previous treatments and be resistant to at least 2 **proteasome inhibitors (PIs)**, 2 **immunomodulatory drugs (IMiDs)**, and 1 **anti-CD38 monoclonal antibody**. Resistance means the disease did not improve by more than 25% or got worse during or shortly after treatment.
- For another treatment group, patients must have received 1 to 5 previous treatments and be resistant to at least 1 PI, 1 IMiD, and 1 anti-CD38 monoclonal antibody.
- Must have an **ECOG performance status** of 2 or less. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 5 being deceased.
- Female patients who can have children must agree to use two methods of birth control and have a negative pregnancy test before starting the study. Male patients must use a reliable barrier method of birth control if they are sexually active with a female who can have children. Both male and female patients must continue using effective birth control during the study and for 7 months for females and 4 months for males after stopping the study treatment.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with penta-refractory multiple myeloma or triple-class refractory multiple myeloma cannot participate. These are specific types of a blood cancer called multiple myeloma that do not respond to certain treatments.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who are part of a vulnerable population, meaning they might not be able to give informed consent or understand the study, cannot participate.

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Verified sites

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Alexandra Hospital
Athens, Greece
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Theageneio Cancer Hospital
Thessaloniki, Greece

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Investigated drugs

Selinexor
is a medication used in this trial to treat patients with multiple myeloma, a type of blood cancer. It works by blocking certain proteins in cancer cells, which can help to stop the growth and spread of the cancer.
Dexamethasone
is a steroid used in combination with other medications in this trial. It helps to reduce inflammation and can also help to kill cancer cells or make them more sensitive to other cancer treatments.
Bortezomib
is another medication used in this trial for patients with multiple myeloma. It works by interfering with the growth of cancer cells and is often used in combination with other treatments to enhance their effectiveness.

What is already known about the treatment

Selinexor
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, specifically in patients who are resistant to multiple previous treatments. It is primarily used for penta-refractory and triple-class refractory multiple myeloma. Selinexor works by inhibiting a protein that helps cancer cells grow and survive, thereby promoting cancer cell death. It is classified as a selective inhibitor of nuclear export, which means it blocks the transport of certain proteins from the nucleus of the cell to the cytoplasm, disrupting cancer cell function.
Dexamethasone
This medication is taken orally and is commonly used in combination with other drugs to treat multiple myeloma. It is a well-established medication in medical literature and is used to reduce inflammation and suppress the immune system. Dexamethasone works by mimicking the effects of hormones produced by the adrenal glands, which helps to decrease inflammation and alter the body's immune response. It is classified as a corticosteroid.
Bortezomib
This medication is administered via injection and is used in combination with other drugs for the treatment of multiple myeloma. It is an established treatment option and is used for patients who have not responded to other therapies. Bortezomib works by inhibiting the proteasome, a complex that breaks down proteins in cells, leading to cancer cell death. It is classified as a proteasome inhibitor.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply uncontrollably, leading to bone damage, anemia, kidney problems, and increased risk of infections. As the disease progresses, it can cause bone pain, fractures, and fatigue due to the overproduction of abnormal proteins. The disease is characterized by periods of remission and relapse, with symptoms worsening over time. In refractory cases, the disease does not respond to standard treatments, making it more challenging to manage.