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Study Comparing Lenalidomide, Carfilzomib, and Dexamethasone with Lenalidomide, Bortezomib, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma

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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 the effectiveness of different drug combinations for treating Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study involves two treatment groups. One group will receive a combination of drugs called lenalidomide, carfilzomib (also known by its code name PR-171), and dexamethasone. The other group will receive a combination of lenalidomide, bortezomib, and dexamethasone. The purpose of the study is to compare the effectiveness of these two drug combinations in patients who have been newly diagnosed with Multiple Myeloma.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will last for a period of up to 24 months, during which participants will receive their assigned treatment. The study will monitor the response to the treatment, focusing on the status of the disease at 12 months and the progression-free survival, which refers to the length of time during and after the treatment that the patient lives with the disease without it getting worse. The study will also look at the safety and tolerability of the treatments.

Throughout the study, participants will undergo regular assessments to track their health and the effectiveness of the treatment. These assessments will help determine how well the treatments work in achieving a complete response, where no signs of cancer are found, and maintaining this response over time. The study aims to provide valuable information on the best treatment options for patients with newly diagnosed 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 visit and randomization
Upon joining the study, you will attend an initial visit where you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment combination being studied.
Step 2
Treatment phase
If assigned to the first group, you will receive a combination of carfilzomib, lenalidomide, and dexamethasone. Carfilzomib is administered as an intravenous infusion, while lenalidomide and dexamethasone are taken orally.
If assigned to the second group, you will receive a combination of bortezomib, lenalidomide, and dexamethasone. Bortezomib is given as a subcutaneous injection, and lenalidomide and dexamethasone are taken orally.
The specific dosages and frequency of administration will be explained to you by the study team. Treatment will continue for a specified duration, which will be communicated during your visits.
Step 3
Regular monitoring
Throughout the study, you will have regular visits to monitor your health and response to the treatment. These visits will include physical exams, blood tests, and other necessary assessments to ensure your safety and to evaluate the effectiveness of the treatment.
Step 4
End of treatment evaluation
At the end of the treatment phase, you will undergo a final evaluation to assess your response to the therapy. This will include various tests and assessments similar to those conducted during the regular monitoring visits.
Step 5
Follow-up period
After completing the treatment, you will enter a follow-up period where your health will continue to be monitored. This is to track any long-term effects of the treatment and to gather additional data on its effectiveness.

Who can join the trial?

17 criteria

Must be newly diagnosed with **Multiple Myeloma** and have not received any prior chemotherapy or large area radiotherapy for this disease.
Must not have received prior treatment with the drugs **bortezomib** or **lenalidomide**.
Must have a certain level of blood health: **ANC** (a type of white blood cell) ≥ 1.0 x 10⁹/L, **hemoglobin** (a protein in red blood cells) ≥ 8 g/dL, and **platelet count** (cells that help with blood clotting) ≥ 75 x 10⁹/L.
Must have a **creatinine clearance** (a measure of kidney function) ≥ 50 mL/min or a **serum creatinine** level below 2 g/dL.
Females who can have children must have two negative pregnancy tests before starting the study drug **lenalidomide** and agree to use two reliable forms of birth control or practice complete abstinence during the study and for 30 days after.
Males must agree to use a latex condom during sexual contact with females who can have children while in the study and for 90 days after, even if they have had a vasectomy.
Participants in the US and EU (excluding Poland) must agree to be part of the **Revlimid REMS** program, which ensures safe use of the drug.
Must agree to follow pregnancy prevention and counseling guidelines.
Must provide voluntary written consent to participate in the study.
Both candidates for transplant and non-transplant are eligible, but transplant candidates must agree to delay the transplant until after the study treatment.
Must have a diagnosis of symptomatic multiple myeloma according to current criteria before starting treatment.
Must have a certain level of **monoclonal plasma cells** (a type of cell involved in multiple myeloma) in the bone marrow or a biopsy-proven **plasmacytoma** (a type of tumor).
Must have measurable disease, indicated by specific levels of **M-protein** in the blood or urine, or abnormal levels of **serum free light chains**.
A bone marrow sample is required at the start of the study for evaluation purposes.
Must be 18 years of age or older.
Must have an **ECOG performance status** of 0-2, which measures daily living abilities.
Must have adequate liver function, with **bilirubin** (a substance made by the liver) ≤ 1.5 times the upper limit of normal, and liver enzymes **AST** and **ALT** ≤ 3 times the upper limit of normal.

Who cannot join the trial?

9 criteria

Patients who have a different type of cancer other than Multiple Myeloma.
Patients who are under the age of 18 or over the age of 65.
Patients who are pregnant or breastfeeding.
Patients who have a serious infection that is not controlled.
Patients who have had another cancer in the past 5 years, except for skin cancer that is not melanoma.
Patients who have a history of heart problems, such as a heart attack or heart failure.
Patients who have a history of severe allergic reactions to medications.
Patients who are currently participating in another clinical trial.
Patients who have a condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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

Helse Bergen HF
Verified
Bergen, Norway
Helsinki University Central Hospital
Verified
Helsinki, Finland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

Trial locations

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Investigated drugs

Carfilzomib
is a medication used in the treatment of multiple myeloma, a type of blood cancer. It works by blocking the action of certain proteins in cancer cells, which helps to stop their growth and eventually leads to their death. In this trial, Carfilzomib is being tested to see how effective it is when combined with other medications in treating newly diagnosed multiple myeloma.
Lenalidomide
is another medication used to treat multiple myeloma. It helps the immune system attack cancer cells and also stops the growth of new blood vessels that tumors need to grow. In this study, Lenalidomide is used in combination with other drugs to evaluate its effectiveness in improving patient outcomes.
Dexamethasone
is a type of steroid that is often used in cancer treatment. It helps reduce inflammation and can also help kill cancer cells. In this trial, Dexamethasone is used alongside other medications to see if it can enhance their effectiveness in treating multiple myeloma.
Bortezomib
is a medication that is also used to treat multiple myeloma. It works by interfering with the cancer cells' ability to break down proteins, which leads to cell death. In this study, Bortezomib is being compared to Carfilzomib to determine which combination of drugs is more effective for patients with newly diagnosed multiple myeloma.

What is already known about the treatment

Carfilzomib
Carfilzomib is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. The main therapeutic use of Carfilzomib is to help control and reduce the growth of cancer cells in patients with multiple myeloma. At the molecular level, Carfilzomib works by inhibiting proteasomes, which are structures inside cells that break down proteins, leading to the accumulation of proteins that can cause cancer cells to die. It is classified as a proteasome inhibitor in pharmacology.
Lenalidomide
Lenalidomide is taken orally in the form of a capsule. It is widely used in the treatment of multiple myeloma and is well-documented in medical literature. The primary therapeutic indication for Lenalidomide is to slow down or stop the growth of cancer cells and to boost the immune system to help fight the cancer. On a molecular level, Lenalidomide modulates the immune system and affects the tumor environment, which helps in reducing the growth of cancer cells. It is classified as an immunomodulatory drug.
Dexamethasone
Dexamethasone is usually taken orally in tablet form, but it can also be administered as an injection. It is a well-established medication in the treatment of multiple myeloma and other conditions. The main therapeutic use of Dexamethasone is to reduce inflammation and suppress the immune response, which can help in managing symptoms and enhancing the effectiveness of other cancer treatments. At the molecular level, Dexamethasone works by mimicking the effects of cortisol, a natural hormone, to reduce inflammation and immune activity. It is classified as a corticosteroid.
Bortezomib
Bortezomib is administered through an injection, either into a vein or under the skin. It is a well-known treatment option for multiple myeloma and is supported by extensive medical research. The primary therapeutic indication for Bortezomib is to treat multiple myeloma by slowing down or stopping the growth of cancer cells. On a molecular level, Bortezomib inhibits proteasomes, similar to Carfilzomib, leading to the accumulation of proteins that can cause cancer cells to die. It is also classified as a proteasome inhibitor.

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, cancerous plasma cells multiply excessively, leading to the production of abnormal proteins that can cause damage to various organs. As the disease progresses, it can lead to bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The accumulation of these abnormal cells in the bone marrow can also interfere with the production of normal blood cells. Over time, the disease can cause significant damage to bones and other tissues. The progression of Multiple Myeloma is typically characterized by periods of stability and periods of active disease.