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A study of mezigdomide, carfilzomib, and dexamethasone in 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 study focuses on individuals with Multiple Myeloma, which is a type of cancer that affects the plasma cells in the body. The research specifically looks at people with Relapsed or Refractory Multiple Myeloma, meaning the cancer has either returned after previous treatment or has stopped responding to the medicines used in the past. The purpose of the study is to determine the effectiveness of a combination of three medications: mezigdomide (also known as CC-92480), carfilzomib, and dexamethasone.

During the study, participants will receive these medications through different methods. Carfilzomib is given as an intravenous infusion, which is a liquid medicine delivered directly into a vein. Mezigdomide is taken as an oral capsule, and dexamethasone is provided both as an infusion and as an oral medication. The study follows the participants over a period of time to observe how the combination of these drugs affects the disease and how long the cancer remains stable before it begins to grow again.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of treatment
The treatment phase begins with the administration of mezigdomide. this is an oral medication taken in a 1 mg dose.
The treatment also includes carfilzomib, which is given as an intravenous infusion (medicine delivered directly into a vein) at a dose of 56 mg/m2.
Step 2
Administration of dexamethasone
dexamethasone is administered as part of the regimen. one dose of 40 mg is given via infusion, and another dose of 40 mg is taken orally (by mouth).
Step 3
Monitoring and evaluation
The progress of the multiple myeloma (a type of blood cancer) is monitored to determine the progression-free survival, which is the time from the start of the study until the disease worsens or death occurs.
The effectiveness of the treatment is measured by tracking the overall response rate, which identifies how many people experience a reduction in cancer symptoms or size.
The study tracks the minimal residual disease status, which is a highly sensitive test to check if any cancer cells remain in the body.
Safety is monitored by recording any adverse events, which are side effects or health problems that may occur during the treatment.
Health-related quality of life is assessed through specific questionnaires to understand how the symptoms and treatment affect daily living.

Who can join the trial?

15 criteria

You must be at least 18 years old.
You must provide written informed consent, which means you have read and signed a document agreeing to take part in the study.
You must have a confirmed diagnosis of multiple myeloma, a type of blood cancer, and have measurable disease. This means the cancer can be detected through specific tests, such as measuring M-protein (a specific protein produced by cancer cells) in your blood or urine, or by checking serum free light chain levels (specific proteins in the blood).
You must have already received one or two previous treatments for multiple myeloma.
You must have previously taken lenalidomide and an anti-CD38 monoclonal antibody (a type of targeted drug used to treat cancer).
You must have had at least a minimal response (a small reduction in cancer markers) to at least one of your previous treatments.
You must have documented disease progression, meaning your cancer has grown or worsened during or after your last treatment.
You must have an ECOG Performance Status score of 0, 1, or 2. This is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
Male participants must practice true abstinence (not having sex) or agree to use a condom during sexual contact with a woman who could become pregnant. This must continue during any breaks in treatment and for at least 90 days after the last dose of the study drugs.
Male participants must not donate sperm during the study and for at least 90 days after the last dose of the study drugs.
Women who are able to become pregnant must have two negative pregnancy tests before starting and agree to regular pregnancy testing throughout the study.
Women of childbearing potential must either practice true abstinence or use two forms of contraception (such as birth control pills and a condom) starting 28 days before treatment and continuing for at least 28 days after the last dose of mezigdomide, or 6 months after the last dose of carfilzomib, whichever period is longer.
Women must agree not to donate eggs during the study and for at least 28 days after the last dose of mezigdomide.
All participants must agree not to donate blood during the study and for at least 28 days after the last dose of the study treatment.
All participants must follow the specific Pregnancy Prevention Plan outlined in the study documents.

Who cannot join the trial?

38 criteria

People who have already received 3 or more previous lines of therapy, which refers to different types of medical treatments used to manage the disease.
People who have had any major surgery within 28 days before starting the study treatments.
People who have had radiation therapy, which is the use of high-energy rays to treat cancer, for bone issues related to the disease within 14 days before starting the study.
People whose multiple myeloma has spread to the central nervous system, which is the part of the body that includes the brain and spinal cord.
People who have used any systemic anti-myeloma drug therapy, which is medicine that travels through the whole body to treat the cancer, within 14 days before starting the study.
People who have had an allogeneic stem cell transplant, which is a procedure where healthy blood-forming cells are taken from a donor, at any time.
People who have had an autologous stem cell transplant, which is a procedure where a person's own healthy blood-forming cells are collected and then returned to them, within 12 weeks before starting the study.
People with specific other blood or plasma conditions, such as plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or light-chain amyloidosis.
People who test positive for HIV, hepatitis A, hepatitis B, or hepatitis C, which are different types of viral infections.
Women who are pregnant, breastfeeding, or plan to become pregnant during the study.
People who have a medical reason why they cannot take the study medicines, which include mezigdomide, carfilzomib, and dexamethasone.
People currently participating in another interventional study, which is a clinical trial where a participant receives a specific treatment or intervention.
People taking strong CYP3A modulators or proton-pump inhibitors, such as omeprazole, which are medicines used to reduce stomach acid, within 2 weeks of starting the study.
People with any serious medical condition, like an uncontrolled infection or psychiatric illness, that would make participating in the study too risky.
People who had a SARS-CoV-2 (COVID-19) infection within 14 days for mild cases or 28 days for severe cases before starting the study.
People with laboratory abnormalities, which means blood test results that are outside of the normal range, such as:
Low absolute neutrophil count (ANC), which is a measure of white blood cells that help fight infection.
Low platelet count, which are the cells that help the blood clot.
Low hemoglobin, which is a protein in red blood cells that carries oxygen.
Low estimated glomerular filtration rate (eGFR), which is a measure used to check how well the kidneys are filtering the blood.
High serum calcium levels in the blood.
Abnormal levels of AST, ALT, or total bilirubin, which are markers used to check how well the liver is working.
People with gastrointestinal disease or recent stomach surgeries that might change how the body absorbs the study medicine.
People with a history of other malignancies, which is another word for cancer, unless they have been cancer-free for 5 years (with some minor exceptions).
People who have used immunosuppressive medication, which are drugs that lower the body's ability to fight infection, within the last 14 days.
People who cannot follow the study rules or treatment restrictions.
People showing signs of organ dysfunction, which means an organ like the heart, liver, or kidneys is not working correctly.
People with a history of anaphylaxis or hypersensitivity, which are severe allergic reactions, to the study drugs or similar medicines.
People with impaired cardiac function, which means the heart is not pumping blood as well as it should, or a history of a myocardial infarction, which is a heart attack.
People with uncontrolled cardiac arrhythmia, which is an irregular heartbeat, or specific abnormal results on an ECG (an electrical test of the heart).
People who are prisoners or involuntarily held in jail.
People who are unwilling to stop donating blood during the study and for 28 days after.
People who have previously been treated with mezigdomide or carfilzomib.
People with uncontrolled hypertension (high blood pressure) or uncontrolled diabetes (high blood sugar) within 14 days of joining.
People who have received a live vaccine within 3 months before starting the study.
People unable or unwilling to take prophylaxis, which is medicine taken to prevent a disease or condition, such as blood clots or viral infections.
People who have used other investigational agents, which are experimental drugs, within 28 days before the study.
People who have had plasmapheresis, a process where the liquid part of the blood is removed and treated, within the last 28 days.

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Verified sites

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

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Centre Hospitalier De La Cote Basque
Verified
Bayonne, France
Centre Hospitalier Departemental Vendee
Verified
La Roche sur Yon, France

Trial locations

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Investigated drugs

Mezigdomide
is an oral medication taken in capsule form that is being tested as part of this treatment combination to help manage multiple myeloma.
Carfilzomib
is a medication administered through an intravenous infusion into a vein to help treat the cancer cells.
Dexamethasone
is a steroid medication that can be given either through an infusion or taken by mouth to assist in the treatment process.

What is already known about the treatment

Dexamethasone
This medication is a steroid that can be taken as a pill or given through a vein via infusion. It is a widely used drug in medicine to reduce swelling and calm an overactive immune system. At a molecular level, it works by blocking certain proteins that trigger inflammation and immune responses in the body. It is classified as a corticosteroid and is often used to help treat various inflammatory and cancerous conditions.
Carfilzomib
This drug is administered through an intravenous infusion directly into the bloodstream. It is a recognized treatment used in medical practice to manage certain types of blood cancer. The medication works by blocking a specific enzyme that helps cancer cells get rid of damaged proteins, eventually leading to the death of the cancer cell. It belongs to a class of drugs known as proteasome inhibitors.
Mezigdomide
This substance is an experimental medication taken orally in the form of a capsule. While it is currently being studied in clinical trials, it is being developed to treat certain types of blood cancer. It works by helping the body's own immune cells recognize and attack specific cancer cells more effectively. It is classified as an immunomodulatory drug.

Investigated diseases

Multiple myeloma - This is a type of cancer that affects the plasma cells, which are a specific type of white blood cell. These abnormal cells accumulate in the bone marrow and can crowd out healthy blood cells. As the disease progresses, the overproduction of these cells can lead to various complications throughout the body. In relapsed or refractory cases, the disease returns or continues to grow despite previous medical interventions.