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Study on Venetoclax and Dexamethasone for Patients with Relapsed and Refractory Multiple Myeloma with Translocation (11;14)

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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 type of blood cancer called multiple myeloma, specifically in patients whose cancer has returned or is not responding to treatment and who have a specific genetic feature known as translocation (11;14). The study is testing the effectiveness of a combination of two medications: Venetoclax, which is a tablet taken by mouth, and Dexamethasone, which is also a tablet taken by mouth. Venetoclax works by helping to kill cancer cells, while Dexamethasone is a type of steroid that can help reduce inflammation and support the treatment of cancer.

The purpose of the study is to see how well the combination of Venetoclax and Dexamethasone works in treating patients with this specific type of multiple myeloma. Participants in the study will receive these medications and will be monitored over a period of time to assess their response to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study will also look at various aspects such as how long patients live without the disease getting worse, the overall survival rate, and the quality of life during the treatment.

Throughout the study, researchers will also evaluate the safety and tolerability of the treatment, which means they will check for any side effects or adverse reactions. Additionally, the study will explore the relationship between the treatment and the body's immune response, particularly focusing on how well patients respond to pneumococcal vaccines, which are vaccines that protect against certain types of bacterial infections. The study aims to provide valuable information that could help improve treatment options for patients with relapsed or refractory multiple myeloma with translocation (11;14).

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure adequate organ function and the presence of specific genetic markers related to multiple myeloma.
Step 2
Treatment initiation
The treatment phase begins with the administration of venetoclax and dexamethasone. Venetoclax is taken orally in tablet form. The dosage and frequency are determined by the study protocol and adjusted based on individual response and tolerance.
Dexamethasone is also administered orally in tablet form. The dosage is 4 mg, and the frequency is determined by the study protocol.
Step 3
Vaccination
Participants receive vaccinations to prevent infections. This includes the Prevenar 13 vaccine, administered as a suspension for injection, and the Pneumovax vaccine, administered as a solution for injection. These are given intramuscularly.
Step 4
Ongoing monitoring
Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to manage any side effects. This includes blood tests, imaging studies, and other assessments as required by the study protocol.
Step 5
Response evaluation
The primary goal is to evaluate the overall response rate to the combination of venetoclax and dexamethasone. This involves measuring the reduction in disease markers and assessing the clinical benefit.
Step 6
Completion and follow-up
Upon completion of the treatment phase, a follow-up period is conducted to monitor long-term effects and overall survival. This includes periodic assessments to evaluate progression-free survival and quality of life.

Who can join the trial?

21 criteria

Must be a male or female, aged 18 years or older.
Female participants must agree to use a highly effective method of birth control until at least 30 days after the last dose of study treatment. This means using both a hormonal and a barrier method of contraception.
Must be able to understand the purpose and risks of the study and provide signed and dated informed consent.
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Must have adequate organ function, shown by specific laboratory results:
- Absolute neutrophil count (a type of white blood cell) of at least 1,000 cells per cubic millimeter.
- Platelet count (cells that help with blood clotting) of at least 30,000 cells per cubic millimeter, without needing transfusions in the 10 days before starting the study treatment.
- Hemoglobin (a protein in red blood cells) of at least 5 mmol/L; red blood cell transfusions and treatment with erythropoietin are allowed.
- Total Bilirubin (a substance made by the liver) of no more than 1.5 times the upper limit of normal, except for patients with Gilbert’s syndrome who have been approved by the sponsor.
- Alanine transaminase (an enzyme found in the liver) of no more than 3 times the upper limit of normal.
- Renal function: Estimated creatinine clearance (a measure of kidney function) of at least 30 mL/min, calculated by the Cockcroft-Gault formula.
- Must have a prior diagnosis of multiple myeloma.
- Must have had at least one prior line of therapy.
- Must have the presence of t(11;14), a specific genetic marker, confirmed by a test called fluorescent in situ hybridization.
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  Must have relapsed or refractory disease, meaning:
  - The disease has progressed during treatment with the last line of therapy or within 60 days after the last line of therapy, or
  - A minimal response or better was not achieved after completing at least two cycles of the last line of therapy.
  - Must have measurable disease, defined as any of the following:
    
    Serum monoclonal protein (a type of protein in the blood) of at least 10 g/L.
    At least 200 mg of monoclonal protein in the urine over 24 hours.
    Serum free light chain (a type of protein in the blood) of at least 100 mg/L and an abnormal serum kappa to lambda free light chain ratio.
    Must have a life expectancy of at least 6 months.
    Must have an ECOG performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities. Patients with a performance status greater than 2 due only to bone pain from multiple myeloma may be eligible with sponsor approval.
    If the participant is a female of childbearing potential, she must have a negative serum or urine pregnancy test. A female of childbearing potential is defined as any sexually mature female who:
    
    Has not had a hysterectomy (removal of the uterus) or bilateral oophorectomy (removal of both ovaries), and
    Has not been naturally postmenopausal for at least 24 consecutive months. A female who stopped having menstrual cycles due to cancer therapy cannot be considered naturally postmenopausal.

Who cannot join the trial?

4 criteria

Patients who do not have multiple myeloma, a type of blood cancer, cannot participate.
Patients who are not positive for t(11;14), a specific genetic marker, cannot participate.
Patients who are not in the age range of 18 to 65 years old cannot participate.
Patients who are part of a vulnerable population, meaning they need special protection, cannot participate.

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Verified sites

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

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Odense University Hospital
Odense, Denmark
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Rigshospitalet
Copenhagen, Denmark
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Sygehus Lillebaelt Vejle Sygehus
Vejle, Denmark

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Investigated drugs

Venetoclax
is a medication used in this trial to help treat multiple myeloma, a type of blood cancer. It works by targeting and blocking a specific protein that cancer cells need to survive, which may help to kill the cancer cells or stop them from growing.
Dexamethasone
is a type of steroid used in this trial to help reduce inflammation and suppress the immune system. It can also help to kill cancer cells and is often used in combination with other cancer treatments to enhance their effectiveness.

What is already known about the treatment

Venetoclax
Venetoclax is administered orally in tablet form and is currently being studied for its effectiveness in treating multiple myeloma, particularly in patients with a specific genetic marker known as translocation (11;14). It is primarily used for its ability to target and inhibit a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax promotes the death of cancer cells. It is classified as a BCL-2 inhibitor and is being explored in clinical trials to determine its potential benefits in relapsed and refractory multiple myeloma.
Dexamethasone
Dexamethasone is taken orally in tablet form or administered intravenously and is widely used in medicine as a corticosteroid to reduce inflammation and suppress the immune system. In the context of multiple myeloma, it is used to help control symptoms and enhance the effectiveness of other cancer treatments. Dexamethasone works by mimicking the effects of hormones produced by the adrenal glands, reducing inflammation, and modulating immune responses. It is classified as a glucocorticoid and is a standard component of various treatment regimens for multiple myeloma.

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. In this disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause symptoms such as bone pain, frequent infections, anemia, and kidney problems. The abnormal plasma cells produce a protein that can cause damage to various organs, particularly the kidneys. Over time, the disease can lead to weakened bones, increased risk of fractures, and other complications.