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Study on Early Treatment for Multiple Myeloma Relapse Using Carfilzomib, Bortezomib, Daratumumab, Lenalidomide, and Dexamethasone in Patients with MRD Negativity

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 disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study will explore the effectiveness of several treatments, including Carfilzomib (also known as PR-171), Bortezomib, Daratumumab (also known as HuMax-CD38), Lenalidomide, and Dexamethasone. These medications are used in different forms such as injections and capsules, and they work by targeting cancer cells in various ways.

The purpose of the study is to determine if starting treatment early, at the first sign of cancer cells returning in the bone marrow, can help patients live longer without the disease getting worse. The study will be conducted in two parts. In the first part, patients will receive standard treatments to see how many achieve a state called MRD negativity, which means no detectable cancer cells. In the second part, the study will compare two groups of patients: one group will start treatment early based on MRD results, and the other will follow standard guidelines for when to start treatment.

Participants in the study will receive different combinations of the medications mentioned above, either through intravenous administration, subcutaneous injection, or oral use. The study will monitor the patients' health and response to the treatments over time, aiming to find the best approach to manage Multiple Myeloma effectively. The trial is expected to continue until 2032, providing valuable insights into the treatment of this disease.

The research process

The trial runs in 7 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, the patient is confirmed to have multiple myeloma and meets the eligibility criteria. This includes being between 18 and 75 years old, having measurable disease, and agreeing to follow the study protocol.
Step 2
Initial treatment phase
The patient receives initial treatment, which may include high-dose therapy and autologous stem cell transplant (ASCT). This phase aims to achieve minimal residual disease (MRD) negativity, meaning no detectable cancer cells in the bone marrow.
Step 3
Consolidation therapy
The patient undergoes consolidation therapy, which involves four cycles of treatment with a combination of medications: carfilzomib (intravenous), bortezomib (subcutaneous injection), daratumumab (subcutaneous injection), lenalidomide (oral capsules), and dexamethasone (oral tablets).
The goal is to further reduce cancer cells and achieve MRD negativity. The patient's response is measured 30-45 days after the fourth cycle.
Step 4
Monitoring and assessment
The patient's progress is monitored through regular assessments, including MRD testing using Euroflow technology. This helps determine the effectiveness of the treatment and the patient's progression-free survival (PFS).
Step 5
Randomization and further treatment
If the patient achieves MRD negativity, they may be randomized into one of two groups for further treatment. One group receives early treatment at the first sign of cancer cells, while the other follows standard relapse treatment guidelines.
The objective is to compare the PFS and overall survival (OS) rates between the two groups.
Step 6
Ongoing evaluation
Throughout the study, the patient completes health-related quality of life forms and reports any adverse events. These evaluations help assess the impact of the treatment on the patient's well-being.
Step 7
Study completion
The study is estimated to end in September 2032. The patient's participation continues until the study's conclusion or until they meet specific criteria for withdrawal.

Who can join the trial?

14 criteria

Patient must have been newly diagnosed with multiple myeloma, a type of blood cancer.
Patient should be eligible for high-dose therapy and ASCT (a type of stem cell transplant).
Patient must be older than 18 and younger than 75 years at the time of signing the consent form.
Patient must have a measurable disease, which means certain levels of specific proteins in the blood or urine that can be tracked.
Patient must provide voluntary written informed consent, agreeing to participate in the study.
Patient should have an ECOG performance status score of 0, 1, or 2, which indicates how well they can perform daily activities. A score of 3 is acceptable if it is due to myeloma.
Patient must be willing and able to follow the study's schedule and requirements.
Females who can have children must have a negative pregnancy test before joining the study.
Females who can have children and males who are sexually active with such females must agree to use effective birth control during the study and for at least 28 days after the last dose of the study drug.
Male participants must also agree not to donate sperm for at least 28 days after the last dose of the study drug.
For Part 2, the patient must have achieved a state called MRD negativity, meaning no minimal residual disease is detected, after initial treatment.
Patient must have received initial treatment, including ASCT, according to local guidelines.
Patient should have an ECOG performance status score of 0, 1, or 2.
Patient must have had measurable disease at the time of diagnosis.

Who cannot join the trial?

9 criteria

Patients who have not been diagnosed with multiple myeloma, a type of cancer that affects certain cells in the bone marrow.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend required visits.
Patients who have other medical conditions that might interfere with the study or make participation unsafe.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients who have a history of certain other cancers or serious diseases.
Patients who have had a recent infection or illness that could affect the study results.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate.

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Verified sites

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

Sykehuset I Vestfold HF
Responsive
Tonsberg, Norway
Sykehuset Oestfold HF Kalnes
Responsive
Graalum, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Lenalidomide
is a medication used in this trial to help manage multiple myeloma. It works by slowing or stopping the growth of cancer cells and is often used after initial treatments to maintain remission and prevent the cancer from returning.
Daratumumab
is an antibody therapy that targets a specific protein on the surface of myeloma cells. It helps the immune system to identify and destroy these cancer cells, and is used in combination with other treatments to improve outcomes for patients with multiple myeloma.
Bortezomib
is a medication that interferes with the growth of cancer cells by blocking a specific protein that helps them multiply. It is used in the treatment of multiple myeloma to reduce the number of cancer cells and help control the disease.
Dexamethasone
is a type of steroid used in this trial to reduce inflammation and help manage symptoms associated with multiple myeloma. It is often used in combination with other cancer treatments to enhance their effectiveness.

What is already known about the treatment

Lenalidomide – Lenalidomide is administered orally in the form of capsules. It is widely recognized in medical literature as a treatment for multiple myeloma, particularly in patients who have achieved minimal residual disease (MRD) negativity. The medication works by modulating the immune system and inhibiting the growth of cancer cells. It belongs to the pharmacological class of 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. In this disease, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. These proteins can cause damage to bones and other organs, such as the kidneys. As the disease progresses, it can lead to bone pain, fractures, and anemia due to the overcrowding of healthy blood cells. Patients may also experience frequent infections because the immune system is compromised. Over time, the disease can cause significant damage to the body's organs and systems.