Not recruiting

Study on Venetoclax, Carfilzomib, and Dexamethasone 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 plasma cells in the bone marrow. The study is testing a combination of three medications: Venetoclax, Carfilzomib, and Dexamethasone. Venetoclax, also known by its code name ABT-199, is a medication that helps to kill cancer cells by targeting a specific protein. Carfilzomib, sometimes referred to as Kyprolis, is used to block certain proteins in cancer cells, leading to their death. Dexamethasone is a type of steroid that helps reduce inflammation and can also help kill cancer cells.

The purpose of this study is to evaluate the safety and effectiveness of this combination of medications in patients whose multiple myeloma has returned after treatment or has not responded to previous treatments. Participants in the study will receive these medications and will be monitored to see how well the treatment works and how their bodies tolerate it. The study will also compare different doses of Venetoclax to see which is more effective when used with Carfilzomib and Dexamethasone.

Throughout the study, participants will take Venetoclax and Dexamethasone in tablet form, while Carfilzomib will be given as an infusion, which means it is delivered directly into the bloodstream through a vein. The study will last for several years, allowing researchers to gather enough information to understand the long-term effects and benefits of the treatment. Participants will have regular check-ups and tests to monitor their health and the progress of their multiple myeloma.

The research process

The trial runs in 5 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 current health status.
Eligibility criteria include having relapsed or refractory multiple myeloma, being 18 years or older, and meeting specific laboratory parameters.
Step 2
Treatment initiation
The treatment involves a combination of three medications: dexamethasone, venetoclax, and carfilzomib.
Dexamethasone is administered orally in the form of 4 mg tablets.
Venetoclax is also taken orally as film-coated tablets, with doses of either 400 mg or 800 mg, depending on the study group.
Carfilzomib is given through intravenous infusion, using a solution prepared from Kyprolis 60 mg powder.
Step 3
Treatment schedule
The treatment is administered in cycles, with specific dosages and schedules for each medication.
The frequency and duration of administration are determined by the study protocol and adjusted based on individual response and tolerability.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the safety and effectiveness of the treatment.
This includes blood tests, imaging studies, and other evaluations to track disease progression and response to therapy.
Step 5
End of treatment
The study is estimated to conclude by January 21, 2028.
Upon completion of the treatment phase, a final assessment is performed to evaluate overall outcomes and any long-term effects.

Who can join the trial?

9 criteria

The patient must have a performance score of 2 or less on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well they can perform daily activities.
The patient must have multiple myeloma that has come back or is not responding to treatment. This means the disease has progressed after previous treatment or within 60 days of the last therapy.
The patient must have received treatment for multiple myeloma before. For some parts of the study, they should have had at least one but no more than three previous treatments. For another part, at least one previous treatment is required.
The patient must have measurable disease, which means certain levels of specific proteins in the blood or urine that indicate the presence of multiple myeloma.
The patient must meet specific laboratory test results, such as having enough white blood cells, platelets, and hemoglobin, and normal levels of liver and kidney function tests.
The patient must be 18 years of age or older.
The patient or their legal representative must sign a consent form agreeing to participate in the study.
If the patient is female and can have children, she must use an approved method of birth control during the study and for 90 days after the last dose of the study drug. If the patient is male, he must agree to use birth control methods or abstain from sexual intercourse during the study and for 90 days after the last dose.
Females who can have children must have a negative pregnancy test before starting the study and on the first day of taking the study drug.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with Multiple Myeloma, a type of cancer that affects certain cells in the bone marrow.
Patients who have not experienced a return or worsening of their Multiple Myeloma after treatment, known as relapsed or refractory multiple myeloma.
Patients who are not within the specified age range for the study.
Patients who are not able to safely take the study medications, which include venetoclax, carfilzomib, and dexamethasone.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who are part of a vulnerable population that the study cannot safely include.

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Verified sites

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

Verified
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Budapest, Hungary
Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain
Verified
Hospital General Universitario Gregorio Maranon
Madrid, Spain

Trial locations

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Investigated drugs

Venetoclax
is a medication used in this trial to treat patients with relapsed or refractory multiple myeloma. It works by targeting and inhibiting a specific protein that helps cancer cells survive, thereby promoting the death of these cells. The study aims to evaluate its safety and effectiveness when used in combination with other treatments.
Carfilzomib
is another medication involved in the trial. It is a type of cancer treatment known as a proteasome inhibitor. Carfilzomib works by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting these proteasomes, carfilzomib can cause cancer cells to die, making it a useful treatment for multiple myeloma.
Dexamethasone
is a corticosteroid used in this study. It helps reduce inflammation and can also kill cancer cells or make them more sensitive to other cancer treatments. In this trial, dexamethasone is combined with venetoclax and carfilzomib to enhance the overall effectiveness of the treatment regimen for multiple myeloma.

What is already known about the treatment

Venetoclax
Venetoclax is administered orally and is currently being studied in combination with carfilzomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. It is a BCL-2 inhibitor, which means it works by blocking the BCL-2 protein that helps cancer cells survive, thereby promoting their death. Venetoclax is classified as a targeted therapy and is being evaluated for its safety and effectiveness in improving response rates in patients with specific genetic markers, such as t(11;14)-positive multiple myeloma.
Carfilzomib
Carfilzomib is given intravenously and is part of a combination treatment being tested for relapsed or refractory multiple myeloma. It is a proteasome inhibitor, which means it disrupts the protein breakdown process in cancer cells, leading to their death. Carfilzomib is classified as an antineoplastic agent and is being assessed for its ability to enhance treatment outcomes when used with venetoclax and dexamethasone.
Dexamethasone
Dexamethasone is administered orally or intravenously and is used in combination with venetoclax and carfilzomib in clinical trials for relapsed or refractory multiple myeloma. It is a corticosteroid that helps reduce inflammation and modulate the immune response, which can support the effectiveness of other cancer treatments. Dexamethasone is classified as an anti-inflammatory and immunosuppressant, and its role in the combination therapy is to enhance the overall therapeutic effect.

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 called monoclonal protein or M protein, which can be detected in the blood or urine. Over time, the accumulation of these cells and proteins can lead to complications affecting various organs and systems in the body.