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Study on the Effectiveness of Bortezomib, Melphalan, and Prednisone vs. Carfilzomib, Lenalidomide, and Dexamethasone in Older Adults 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 treatments for multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will evaluate the effectiveness of different treatment combinations. The treatments being studied include bortezomib (known as Velcade), melphalan, prednisone, lenalidomide, dexamethasone, carfilzomib, and daratumumab. These medications are used in various combinations to see which works best for patients who are newly diagnosed with multiple myeloma and are between 65 and 80 years old.

The purpose of the study is to compare the effectiveness of these treatments in achieving a complete response, which means the cancer is no longer detectable. Participants will receive one of the treatment combinations for a period of 18 cycles, followed by additional treatment to maintain the response. Some participants will receive a placebo to help researchers understand the true effect of the medications. The study will last several years, with regular check-ups to monitor the participants' health and the progress of the disease.

Throughout the study, participants will be closely monitored to ensure their safety and to track the effectiveness of the treatments. The study aims to find the best treatment approach for older adults with multiple myeloma, improving their chances of a better outcome and quality of life. Participants will receive care from a team of healthcare professionals who specialize in treating multiple myeloma.

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, you will be randomly assigned to one of the treatment groups. This means you will receive one of the different treatment combinations being tested.
Step 2
Induction therapy
The induction therapy phase lasts for 18 cycles. During this time, you will receive a combination of medications depending on your assigned group.
If you are in the control group, you will receive bortezomib (subcutaneous injection), melphalan (oral), and prednisone (oral).
If you are in the experimental group, you will receive carfilzomib (intravenous), lenalidomide (oral), and dexamethasone (oral), with or without daratumumab (subcutaneous injection).
Step 3
Midway evaluation
After 9 cycles of induction therapy, an evaluation will be conducted to assess your response to the treatment. This involves checking the levels of certain proteins in your blood.
Step 4
End of induction evaluation
At the end of the 18 cycles of induction therapy, another evaluation will be conducted to determine the effectiveness of the treatment.
Step 5
Consolidation therapy
Following the induction phase, you will enter the consolidation therapy phase. This phase aims to strengthen the response achieved during induction.
Step 6
Maintenance therapy
After consolidation, you will begin maintenance therapy. This phase involves taking lenalidomide (oral) and possibly daratumumab (subcutaneous injection) to maintain the response to treatment.
Maintenance therapy will continue for at least five years, with regular evaluations to monitor your health and response to the treatment.
Step 7
Regular evaluations
Throughout the trial, regular evaluations will be conducted to monitor your health, the effectiveness of the treatment, and any side effects you may experience.

Who can join the trial?

16 criteria

Patients must have been newly diagnosed with multiple myeloma and need to start treatment.
The heart's left ventricle must be working at 40% or better. This is called the left ventricle ejection fraction.
Male patients taking the drug lenalidomide must use condoms during sexual activity with women who are pregnant or could become pregnant, even if they have had a vasectomy. Alternatively, they must agree to total abstinence. This must continue during treatment and for at least 30 days after treatment ends. They must also agree not to donate sperm during treatment and for at least 90 days after treatment ends.
Patients must be between 65 and 80 years old.
Patients should be in good overall health, as measured by a health status scale. A score of 42 or less on this scale is required.
Patients must sign an informed consent form, agreeing to participate in the study.
Patients must have a measurable disease. This means:
- For secretory multiple myeloma, there must be a certain level of a protein called M-protein in the blood or a certain amount of free light chains in the urine.
- For oligo-secretory or non-secretory multiple myeloma, the level of free light chains in the blood must be at a certain level with an abnormal ratio.
- Patients must have a functional status of 2 or less, as defined by a specific scale used to measure daily living abilities.
- Patients must have a life expectancy of more than 3 months.
- Patients must have adequate organ function, which includes:
  - A certain level of platelets, hemoglobin, and neutrophils in the blood.
  - Liver enzymes (AST and ALT) must not be more than 2.5 times the normal limit.
  - Total bilirubin must not be more than 2 times the normal limit.
  - Serum creatinine must be 2 mg/dl or less.
  - Calcium levels must be 14 mg/dl or less, even if albumin levels are not normal.
  - The investigator must believe that the patient can follow all the study requirements.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer other than multiple myeloma.
Patients who are eligible for a bone marrow transplant. This is a procedure to replace damaged or destroyed bone marrow with healthy bone marrow stem cells.
Patients who are not in good general health. This means that the patient should not have other serious health problems that could affect the study.
Patients who are part of a vulnerable population. This includes groups of people who may need special protection, such as children, pregnant women, or those unable to make decisions for themselves.

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Verified sites

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Responsive
Complexo Hospitalario Universitario De Vigo
Vigo, Spain
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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Investigated drugs

Bortezomib
is a medication used to treat multiple myeloma, a type of blood cancer. It works by blocking certain proteins in cancer cells, which helps to slow down or stop their growth. In this trial, it is part of the initial treatment phase to help reduce the number of cancer cells in the body.
Melphalan
is a chemotherapy drug that is used to treat multiple myeloma. It works by damaging the DNA of cancer cells, which prevents them from multiplying. This helps to control the spread of the disease and reduce symptoms.
Prednisone
is a type of steroid that is used to help reduce inflammation and suppress the immune system. In the context of multiple myeloma, it is used to help manage symptoms and improve the effectiveness of other cancer treatments.
Lenalidomide
is a medication that helps the immune system fight cancer. It works by slowing the growth of cancer cells and helping the body’s immune system attack them. It is used in this trial as part of both the initial and maintenance treatment phases.
Dexamethasone
is a steroid that helps reduce inflammation and is used to treat various conditions, including multiple myeloma. It is often used in combination with other cancer treatments to help improve their effectiveness and manage side effects.
Carfilzomib
is a medication used to treat multiple myeloma. It works by blocking certain proteins in cancer cells, which helps to stop their growth and spread. It is part of the experimental treatment being tested in this trial.

What is already known about the treatment

Bortezomib
Bortezomib is administered as an injection, typically given under the skin or into a vein. It is currently used in the treatment of multiple myeloma, a type of blood cancer, and is well-documented in medical literature. The main therapeutic indication for bortezomib is to help control and reduce the spread of cancer cells in multiple myeloma. At the molecular level, bortezomib works by inhibiting a protein complex called the proteasome, which helps regulate protein degradation in cells, leading to cancer cell death. It is classified as a proteasome inhibitor.
Melphalan
Melphalan is usually administered orally in tablet form or as an injection into a vein. It is a well-established medication in the treatment of multiple myeloma and is widely referenced in medical literature. The primary use of melphalan is to slow or stop the growth of cancer cells in multiple myeloma. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. Melphalan is classified as an alkylating agent.
Prednisone
Prednisone is taken orally in tablet form. It is commonly used in the treatment of multiple myeloma and is extensively documented in medical literature. Prednisone helps reduce inflammation and suppresses the immune system, which can help control the symptoms of multiple myeloma. It works by mimicking the effects of hormones produced by the adrenal glands. Prednisone is classified as a corticosteroid.
Lenalidomide
Lenalidomide is administered orally in capsule form. It is widely used in the treatment of multiple myeloma and is well-documented in medical literature. The main therapeutic indication for lenalidomide is to help control the progression of multiple myeloma. It works by enhancing the immune system's ability to fight cancer and by directly inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory agent.
Dexamethasone
Dexamethasone is taken orally in tablet form or administered as an injection. It is a well-known medication used in the treatment of multiple myeloma and is extensively covered in medical literature. Dexamethasone helps reduce inflammation and suppresses the immune system, which can help manage the symptoms of multiple myeloma. It works by mimicking the effects of hormones produced by the adrenal glands. Dexamethasone is classified as a corticosteroid.
Carfilzomib
Carfilzomib is administered as an injection into a vein. It is used in the treatment of multiple myeloma and is well-documented in medical literature. The main therapeutic indication for carfilzomib is to help control and reduce the spread of cancer cells in multiple myeloma. At the molecular level, carfilzomib works by inhibiting the proteasome, a protein complex that helps regulate protein degradation in cells, leading to cancer cell death. It is 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 and crowd out healthy blood cells, leading to bone damage, anemia, and increased risk of infections. As the disease progresses, it can cause bone pain, fractures, and kidney problems due to the accumulation of abnormal proteins produced by the cancerous cells. Over time, the disease can lead to significant bone loss and damage to other organs. The progression of multiple myeloma is typically slow, but it can vary greatly between individuals. The disease is characterized by periods of stability and periods of active disease, where symptoms become more pronounced.