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Study on Daratumumab, Carfilzomib, Pomalidomide, and Dexamethasone for Patients with Multiple Myeloma and Acute Kidney Failure

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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 particularly interested in patients who have developed acute kidney problems due to this disease. The treatment being tested involves a combination of medications: daratumumab, carfilzomib, pomalidomide, and dexamethasone. These medications are used together to see if they can help improve kidney function in patients with multiple myeloma.

The purpose of the study is to determine the safety and effectiveness of this combination treatment in helping patients recover kidney function. Participants will receive the treatment over four cycles. Some of the medications are given as infusions, which means they are delivered directly into the bloodstream, while others are taken orally as tablets or capsules. The study will monitor how well the kidneys recover and whether patients can stop needing dialysis, which is a treatment that helps clean the blood when the kidneys are not working well.

Throughout the study, researchers will also look at how long patients can live without the disease getting worse and how well they respond to the treatment. The study will track any side effects and changes in the patients' health. This research aims to provide valuable information on whether this combination of medications can be a safe and effective option for treating kidney problems caused by 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
Beginning of treatment
Upon joining the clinical trial, the treatment begins with the administration of medications designed to address multiple myeloma and its effects on kidney function.
The treatment involves a combination of four medications: daratumumab, carfilzomib, pomalidomide, and dexamethasone.
Step 2
Medication administration
Daratumumab is given as a solution for infusion, which means it is administered through a needle under the skin. This is known as subcutaneous use.
Carfilzomib is provided as a solution for infusion, administered intravenously, meaning it is given directly into a vein.
Pomalidomide is taken orally in the form of hard capsules. The dosage may vary, with available strengths of 1 mg, 2 mg, 3 mg, and 4 mg.
Dexamethasone is also taken orally in the form of tablets, with available strengths of 4 mg and 8 mg.
Step 3
Treatment cycles
The treatment is structured into 4 cycles. Each cycle represents a period during which the medications are administered according to a specific schedule.
The goal of these cycles is to assess the safety and effectiveness of the treatment, particularly focusing on the recovery of kidney function.
Step 4
Monitoring and assessment
Throughout the trial, regular monitoring is conducted to evaluate the response to the treatment. This includes checking kidney function and overall health.
The primary aim is to determine if patients who require dialysis can become independent of it, and if those not on dialysis can improve their kidney function.
Step 5
End of treatment
After completing the 4 cycles, the treatment phase of the trial concludes.
Further assessments may be conducted to evaluate the long-term effects and benefits of the treatment.

Who can join the trial?

14 criteria

Patients must have untreated multiple myeloma and kidney problems caused by the myeloma, either needing dialysis or having very low kidney function.
Patients must not have had any other cancers for at least 2 years, except for certain skin cancers or early-stage cancers of the cervix or breast that have been completely removed.
Female patients must be older than 50 years and postmenopausal for at least 1 year, or surgically sterile, or if they can have children, they must agree to use two effective birth control methods from 4 weeks before starting the study until 90 days after the last dose, or agree to complete abstinence.
Female patients must understand the potential risks of the study drug, pomalidomide, which can cause birth defects.
Male patients, even if they have had a vasectomy, must agree to use effective barrier contraception during the study and for 90 days after the last dose, or agree to complete abstinence.
Male patients must understand the potential risks of the study drug, pomalidomide, which can cause birth defects.
Patients must be between 18 and 70 years old.
Patients must give voluntary written consent before starting treatment, understanding they can withdraw at any time without affecting future medical care.
Patients must have measurable disease, which means certain levels of specific proteins in the blood or urine.
Patients must have a life expectancy of more than 3 months.
Patients must have an ECOG performance status of 3 or less. ECOG is a scale used to assess how a disease affects a patient's daily living abilities. A score of 3 means the patient is bedridden or needs care due to their condition.
Patients must have a certain level of white blood cells and platelets. Platelet transfusions are allowed to meet this requirement within 3 days before joining the study.
Patients must have a total bilirubin level that is no more than twice the upper limit of normal (ULN).
Patients must have ALT and AST levels that are no more than three times the ULN. ALT and AST are enzymes that help assess liver function.

Who cannot join the trial?

14 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer within the last 5 years, except for skin cancer that is not melanoma.
Patients who have an active infection that requires treatment.
Patients who have had a heart attack or stroke within the last 6 months.
Patients who have severe heart disease.
Patients who have uncontrolled high blood pressure.
Patients who have severe liver disease.
Patients who have severe lung disease.
Patients who have a known allergy to any of the study drugs.
Patients who are currently participating in another clinical trial.
Patients who have received certain treatments for multiple myeloma in the past.
Patients who have a history of drug or alcohol abuse within the last 2 years.
Patients who have a mental health condition that would make it difficult to follow the study procedures.

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Medizinische Universitaet Innsbruck
Innsbruck, Austria

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Investigated drugs

Daratumumab
is a medication used in the treatment of multiple myeloma, a type of blood cancer. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this trial, daratumumab is being used to help improve kidney function in patients whose kidneys have been affected by multiple myeloma.
Carfilzomib
is a medication that helps treat multiple myeloma by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting proteasomes, carfilzomib causes an accumulation of proteins in cancer cells, leading to their death. This medication is part of the combination therapy being tested to see if it can help restore kidney function in affected patients.
Pomalidomide
is a drug that modifies the immune system and has anti-cancer effects. It works by stopping the growth of cancer cells and helping the immune system attack them. In this trial, pomalidomide is used alongside other medications to see if it can help improve kidney function in patients with multiple myeloma.
Dexamethasone
is a type of steroid that reduces inflammation and suppresses the immune system. It is often used in combination with other cancer treatments to enhance their effectiveness. In this study, dexamethasone is part of the treatment regimen to help manage multiple myeloma and its effects on the kidneys.

What is already known about the treatment

Daratumumab
Daratumumab is administered as an injection, typically given into a vein. It is currently used in medicine to treat multiple myeloma, a type of blood cancer. The medication works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.
Carfilzomib
Carfilzomib is given as an injection into a vein. It is used in the treatment of multiple myeloma, particularly in patients who have not responded to other treatments. The drug works by blocking the action of proteasomes, which are structures inside cells that break down proteins. This leads to the accumulation of proteins in cancer cells, causing them to die. Carfilzomib is classified as a proteasome inhibitor.
Pomalidomide
Pomalidomide is taken orally in the form of a capsule. It is used to treat multiple myeloma, especially in patients who have tried other treatments without success. The medication works by affecting the immune system and directly attacking cancer cells, slowing their growth and spread. It is classified as an immunomodulatory agent.
Dexamethasone
Dexamethasone is usually taken orally in tablet form, but it can also be given as an injection. It is used in combination with other medications to treat multiple myeloma. Dexamethasone works by reducing inflammation and suppressing the immune system, which can help control the symptoms of cancer. It is classified as a corticosteroid.

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. As the disease progresses, abnormal plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. This can result in symptoms such as bone pain, anemia, and increased risk of infections. Over time, the disease can cause damage to the kidneys and other organs due to the high levels of abnormal proteins produced by the cancerous cells. The progression of multiple myeloma can vary, with periods of stability followed by phases of active disease. The condition is considered chronic and requires ongoing monitoring and management.