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Study on KRd Consolidation for Multiple Myeloma Patients with Positive PET-CT: Carfilzomib, Lenalidomide, and Dexamethasone Treatment

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 Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study will use a combination of treatments known as KRd consolidation, which includes the medications Carfilzomib (also known by its code name PR-171), Lenalidomide, and Dexamethasone. These medications are used to help patients who have already received standard first-line treatment for Multiple Myeloma and still show signs of the disease on a PET-CT scan, a type of imaging test that helps doctors see how the cancer is responding to treatment.

The purpose of this study is to see how many patients with a positive PET-CT scan after their initial treatment can become PET-negative after receiving four cycles of KRd consolidation. The study will involve taking these medications over a period of time, with Carfilzomib given as an infusion, which means it is administered directly into the bloodstream, and Lenalidomide and Dexamethasone taken orally, meaning by mouth. The study will also include a group of patients who will receive a placebo, which is a substance with no active medication, to compare the effects of the KRd treatment.

Throughout the study, researchers will monitor the safety of the treatment and assess various outcomes, such as the overall response rate, progression-free survival, and quality of life during and after the treatment. The study aims to provide valuable information on the effectiveness of KRd consolidation in improving the condition of patients with Multiple Myeloma who have not fully responded to their initial treatment.

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, eligibility is confirmed based on specific criteria, including age, health status, and previous treatment history.
A positive PET-CT scan result is required, indicating the presence of active disease after initial treatment.
Step 2
Medication administration
The treatment involves a combination of medications: dexamethasone, carfilzomib, and lenalidomide.
Dexamethasone is taken orally. The dosage and frequency are determined by the study protocol.
Carfilzomib is administered through infusion. The dosage and schedule are specified in the study guidelines.
Lenalidomide is also taken orally, with dosage and frequency outlined in the study plan.
Step 3
Treatment cycles
The treatment consists of 4 cycles of KRd consolidation therapy.
Each cycle includes the administration of the medications as per the study protocol.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the response to treatment.
PET-CT scans are performed to evaluate changes in disease activity.
Additional assessments may include blood tests and other evaluations to monitor health and treatment effects.
Step 5
End of treatment evaluation
At the end of the 4 cycles, a final evaluation is conducted to determine the treatment's effectiveness.
The primary goal is to assess the change from PET-CT positivity to PET-CT negativity.
Step 6
Follow-up
After completing the treatment cycles, follow-up visits are scheduled to monitor long-term outcomes.
These visits may include assessments of overall health, disease status, and quality of life.

Who can join the trial?

12 criteria

Must be at least 18 years old and expected to live for at least 6 more months.
Must have a certain level of physical ability, measured by the Eastern Cooperative Oncology Group (ECOG) performance status. This is a scale that helps doctors understand how well a patient can perform daily activities. For those over 75 years old, a slightly better performance is required.
Must have adequate organ and bone marrow function. This includes having a certain number of neutrophils (a type of white blood cell) and platelets (cells that help with blood clotting) in the blood. Blood transfusions to meet these levels are not allowed within 3 days before joining the study, but certain medications to boost blood cell production are allowed.
Must be willing and able to follow the study schedule and other requirements.
Must have a confirmed diagnosis of multiple myeloma from 2014.
Must have received standard first line treatment for multiple myeloma and achieved at least a very good partial response. This treatment includes specific drug combinations and possibly a stem cell transplant, with or without additional medication.
Must not have been treated with carfilzomib before. Carfilzomib is a medication used to treat multiple myeloma.
Must have a positive result from a PET-CT scan, which is a type of imaging test, during the screening period.
Must have a successful FISH evaluation, which is a test that looks at the chromosomes in cells, with available results.
Must provide voluntary written consent before any study-related procedures that are not part of standard medical care. The patient can withdraw consent at any time without affecting future medical care.
Females who can become pregnant must have a confirmed negative pregnancy test within 7 days before joining the study.
Females who can become pregnant and males who are sexually active with such females must agree to use highly effective birth control methods during the study and for 30 days after the last dose of the study drug. Males must also agree to use contraception and not donate sperm for at least 90 days after the last dose of carfilzomib.

Who cannot join the trial?

3 criteria

Patients who have not been diagnosed with Multiple Myeloma cannot participate. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

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Verified sites

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

Odense University Hospital
Verified
Odense, Denmark
Oslo Universitetssykehus HF
Verified
Oslo, Norway
Rigshospitalet
Verified
Copenhagen, Denmark

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Investigated drugs

KRd consolidation therapy is a combination treatment used in this clinical trial for patients with myeloma. It includes three medications: carfilzomib, lenalidomide, and dexamethasone. This therapy is given to patients who have already received standard first-line treatment but still show positive results on a PET-CT scan. The goal of KRd consolidation is to help these patients achieve a negative PET-CT result, indicating a better response to treatment.

What is already known about the treatment

KRd (Carfilzomib, Lenalidomide, Dexamethasone) – This combination therapy is administered intravenously and orally, depending on the specific drug in the regimen. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, particularly in patients who remain PET-positive after initial treatment. The main therapeutic indication is to help these patients achieve a PET-negative status, indicating a reduction in cancer activity. At the molecular level, Carfilzomib works by inhibiting proteasomes, which are enzyme complexes that break down proteins, leading to cancer cell death. Lenalidomide modulates the immune system and inhibits angiogenesis, while Dexamethasone is a corticosteroid that reduces inflammation and suppresses immune responses. This combination falls under the pharmacological classification of antineoplastic agents and immunomodulatory drugs.

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 cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones and other organs. As the disease progresses, it can result in bone pain, fractures, and anemia due to the crowding out of healthy blood cells. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses in stages, with symptoms worsening over time if not managed.