Not recruiting

Study of Belantamab Mafodotin, Carfilzomib, and Dexamethasone for Patients with Relapsed Multiple Myeloma Resistant to Lenalidomide

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 type of cancer called Multiple Myeloma, which affects the blood and bone marrow. The study is testing a combination of treatments to see how well they work together. The treatments being used are Belantamab Mafodotin, Carfilzomib, and a medication called Dexamethasone. These medications are given through an injection into a vein, which is known as intravenous use.

The purpose of the study is to find the best dose of Belantamab Mafodotin when used with Carfilzomib and Dexamethasone, and to see how effective this combination is in treating patients whose myeloma has returned after treatment with another drug called lenalidomide. The study will also look at how safe and tolerable the combination is for patients. The study is divided into two phases. In the first phase, researchers will determine the best dose of the combination. In the second phase, they will evaluate how well the treatment works over 12 months, including how many patients have no remaining signs of cancer.

Participants in the study will receive the treatment and be monitored for their response to the medication, as well as any side effects they may experience. The study will also track how long the treatment keeps the cancer from getting worse and how long patients live after starting the treatment. This information will help doctors understand the potential benefits and risks of using Belantamab Mafodotin with Carfilzomib and Dexamethasone for treating 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, you will be asked to provide written informed consent. This means you agree to participate in the study after understanding all the procedures involved. You can withdraw your consent at any time without affecting your future medical care.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you meet the study's eligibility criteria. This includes confirming that you have multiple myeloma and are refractory to lenalidomide, meaning your condition has not improved with this medication.
Your medical history will be reviewed, and tests will be conducted to measure your disease status and organ function.
Step 3
Lead-in phase
During the lead-in phase, the study aims to determine the maximum tolerated dose of belantamab mafodotin in combination with carfilzomib and dexamethasone. These medications will be administered through an intravenous route, meaning they will be given directly into your vein.
The dosage and frequency of administration will be adjusted based on your response and any side effects experienced.
Step 4
Expansion phase
In the expansion phase, the study will evaluate the effectiveness of the medication combination over a 12-month period. The goal is to assess the complete response rate and the rate of minimal residual disease negativity, which indicates the absence of detectable cancer cells.
Your health and response to the treatment will be closely monitored through regular check-ups and tests.
Step 5
Safety and tolerability evaluation
Throughout the trial, the safety and tolerability of the medication combination will be evaluated. This involves monitoring for any adverse effects or changes in your health status.
Regular assessments will be conducted to ensure your well-being and to make any necessary adjustments to your treatment plan.
Step 6
Follow-up
After completing the treatment phase, follow-up visits will be scheduled to monitor your long-term health and any lasting effects of the treatment.
These visits will help gather information on the duration of response and overall survival rates.

Who can join the trial?

13 criteria

The patient must be willing and able to follow the study rules, according to the doctor's opinion.
Female participants must use birth control methods that follow local rules for clinical studies.
Male participants must use birth control methods that follow local rules for clinical studies.
Any side effects from previous treatments must be mild (Grade 1 or less) when joining the study, except for hair loss.
The patient must understand the study procedures and agree to participate by signing a written consent form.
The patient must have given written consent voluntarily before any study-related procedures, knowing they can withdraw at any time without affecting their future medical care.
The patient must have relapsed multiple myeloma and have received at least 1 but no more than 3 previous treatments. A treatment plan including induction, high-dose melphalan, stem cell transplant, and maintenance counts as one treatment.
The patient must be refractory to lenalidomide, meaning their disease worsened while on lenalidomide or within 60 days after the last dose, regardless of the dose or combination with other drugs.
The patient may have had previous treatment with proteasome inhibitors. If they had bortezomib, they are eligible regardless of their response. If they had carfilzomib, they must have had at least a partial response and a break of at least 6 months before joining the study.
The patient must have a measurable disease, which means having a certain level of specific proteins in the blood or urine.
The patient must have an ECOG performance status of 2 or less, which is a scale to measure how well they can perform daily activities.
The patient must be 18 years of age or older.
The patient must have adequate organ function, as defined in the study's criteria.

Who cannot join the trial?

10 criteria

Patients with any other active cancer cannot participate.
Patients who have had a heart attack or severe heart problems in the past 6 months are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe lung disease are excluded.
Patients with active infections that require treatment are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with known allergies to the study drugs are excluded.
Patients who have received another investigational drug within the last 4 weeks are not eligible.
Patients with a history of drug or alcohol abuse in the past 12 months cannot participate.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

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Verified sites

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

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario De Canarias
Verified
La Laguna, Spain
Hospital Universitario De Leon
Verified
Leon, Spain

Trial locations

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Investigated drugs

Belantamab mafodotin
is a medication used in this clinical trial to treat patients with relapsed myeloma, a type of blood cancer. It works by targeting and attaching to a specific protein found on the surface of cancer cells. Once attached, it delivers a toxic substance directly into the cancer cells, helping to kill them. This medication is being tested in combination with other drugs to see if it can improve treatment outcomes for patients who have not responded to other therapies.
Carfilzomib
is another medication used in this 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 causes an accumulation of proteins within the cancer cells, leading to their death. This medication is used in combination with others to enhance its effectiveness against myeloma.
Dexamethasone
is a steroid medication included in the trial. It helps reduce inflammation and suppresses the immune system. In the context of cancer treatment, dexamethasone is used to help manage side effects and enhance the effectiveness of other cancer therapies. It is often used in combination with other medications to improve treatment outcomes for patients with myeloma.

What is already known about the treatment

Belantamab mafodotin – Belantamab mafodotin is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer, especially in patients who have not responded to other treatments like lenalidomide. The medication works by targeting and binding to a specific protein on the surface of cancer cells, delivering a toxic agent that helps kill these cells. It is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to specifically target cancer cells while minimizing damage to healthy cells.

Investigated diseases

Multiple myeloma – Multiple myeloma is a type of blood 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 a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, frequent infections, and anemia. Over time, the accumulation of abnormal plasma cells can lead to weakened bones and increased risk of fractures. The disease can also result in high levels of calcium in the blood, which can cause further complications.