Not recruiting

Study Comparing Bortezomib, Melphalan, Prednisone, Lenalidomide, and Daratumumab for Multiple Myeloma in Patients Ineligible for Stem Cell Transplant

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 treatments for Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves patients who are newly diagnosed and are either 65 years or older or are not eligible for a procedure called autologous stem cell transplant. The trial compares two standard treatment combinations: Bortezomib-Melphalan-Prednisone (VMP) and Lenalidomide-Dexamethasone (Rd), both with or without the addition of Daratumumab, a monoclonal antibody that helps the immune system fight cancer cells.

The purpose of the study is to compare how long patients live without their disease getting worse when treated with these combinations. Participants will be randomly assigned to receive one of the treatment combinations. The study will monitor patients over time to see how well the treatments work and to check for any side effects. Some patients may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, patients will have regular check-ups and tests to monitor their health and the progress of the disease. The study aims to provide valuable information on the effectiveness and safety of these treatment combinations in a real-world setting, helping to improve future treatment options for people with 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 treatment phase
Upon joining the study, the patient will be assigned to one of two treatment groups. The first group will receive a combination of bortezomib, melphalan, and prednisone (VMP) with or without daratumumab (Dara-VMP). The second group will receive lenalidomide and dexamethasone (Rd) with or without daratumumab (Dara-Rd).
The medications will be administered in various forms: oral capsules, subcutaneous injections, and infusions. The specific dosage and frequency will depend on the assigned treatment group.
Step 2
Treatment administration
For the VMP group, bortezomib is given as a subcutaneous injection, melphalan as an oral tablet, and prednisone as an oral tablet. Daratumumab may be added as an infusion.
For the Rd group, lenalidomide is administered as an oral capsule, and dexamethasone as an oral solution. Daratumumab may be added as an infusion or injection.
Step 3
Monitoring and assessments
Throughout the trial, regular monitoring will occur to assess the patient's response to treatment. This includes blood tests, imaging studies, and health questionnaires.
The primary goal is to evaluate progression-free survival, which measures the time during and after treatment that the patient lives without the disease worsening.
Step 4
Follow-up and evaluation
Patients will be followed up regularly to monitor for any side effects or complications. The safety and effectiveness of the treatments will be evaluated.
Quality of life will be assessed using specific questionnaires every three months for the first year and every six months thereafter.
Step 5
End of trial
The trial is expected to conclude by May 2028. At the end of the study, the collected data will be analyzed to determine the effectiveness and safety of the treatments.
Patients who complete the study will have their final assessments and will be informed of the overall results.

Who can join the trial?

15 criteria

The patient must provide voluntary written consent before any study-related procedures begin.
The patient must have a clonal bone marrow plasma cell percentage of 60% or more. This means a specific type of cell in the bone marrow is present in a high amount, which is confirmed by certain tests.
The patient must have a specific ratio of proteins in the blood, known as the serum free light chain ratio, of 100 or more. This is measured by a blood test.
The patient must have more than one focal lesion detected by MRI. A focal lesion is an area of abnormal tissue, and each must be 5 mm or larger.
The patient must be able to undergo one of the two standard treatments and procedures, as determined by their doctor.
Females who can have children must use an effective birth control method for 28 days before starting the study treatment, during the treatment, and for at least 3 months after the last dose of study drugs.
Male patients must use an effective barrier method of birth control if sexually active with a female who can have children during treatment and for at least 6 months after the last dose of study drug.
The patient must be ineligible for an autologous stem cell transplant (ASCT), which means they are either 65 years or older, younger than 65 but choose not to have the transplant, or have certain health issues like heart, lung, liver, or kidney problems.
The patient must have newly diagnosed symptomatic multiple myeloma, a type of blood cancer, based on specific criteria set by the International Myeloma Working Group (IMWG).
The patient must show evidence of damage to organs due to the disease, such as:
High calcium levels in the blood, known as hypercalcemia.
Kidney problems, indicated by low creatinine clearance or high serum creatinine levels.
Anemia, which means low levels of hemoglobin in the blood.
Bone lesions, which are areas of bone damage seen on imaging tests like X-rays or CT scans.
The patient must have certain biomarkers of malignancy, which are indicators of cancer in the body.

Who cannot join the trial?

5 criteria

Patients who have not been newly diagnosed with **MM** (Multiple Myeloma) or are under 65 years old.
Patients who are eligible for an **autologous stem cell transplant**. This is a procedure where a patient's own stem cells are used to replace damaged or diseased bone marrow.
Patients who do not meet the specific age range required for the study.
Patients who do not belong to the clinical trial groups specified for the study.
Patients who are not part of the vulnerable population selected for the study.

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy

Trial locations

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Investigated drugs

Bortezomib
is a medication used to treat multiple myeloma. It works by interfering with the growth of cancer cells, slowing their spread in the body.
Melphalan
is a chemotherapy drug that helps to stop the growth of cancer cells. It is often used in combination with other medications to treat multiple myeloma.
Prednisone
is a corticosteroid that helps reduce inflammation and suppresses the immune system. It is used in combination with other drugs to treat multiple myeloma.
Daratumumab
is a monoclonal antibody that targets specific proteins on the surface of cancer cells. It helps the immune system to identify and destroy these cells, and is used in combination with other treatments for multiple myeloma.
Lenalidomide
is an immunomodulatory drug that helps the immune system attack cancer cells. It also prevents the growth of new blood vessels that tumors need to grow.
Dexamethasone
is a corticosteroid that reduces inflammation and helps to control the immune response. It is used alongside other medications to treat multiple myeloma.

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, particularly for patients who are newly diagnosed and ineligible for stem cell transplants. Bortezomib works by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, leading to cancer cell death. It is classified as a proteasome inhibitor.
Melphalan
Melphalan is taken orally in tablet form or administered intravenously. It is used in the treatment of multiple myeloma, especially for patients who cannot undergo stem cell transplants. Melphalan works by damaging the DNA in cancer cells, preventing them from multiplying. It is classified as an alkylating agent.
Prednisone
Prednisone is taken orally in tablet form. It is used in combination with other medications to treat multiple myeloma. Prednisone works by suppressing the immune system and reducing inflammation, which helps control the growth of cancer cells. It is classified as a corticosteroid.
Daratumumab
Daratumumab is administered as an intravenous infusion. It is used in combination with other treatments for multiple myeloma, particularly in patients who are not eligible for stem cell transplants. Daratumumab works by targeting a specific protein on the surface of cancer cells, leading to their destruction. It is classified as a monoclonal antibody.
Lenalidomide
Lenalidomide is taken orally in capsule form. It is used to treat multiple myeloma, often in combination with other drugs. Lenalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory agent.
Dexamethasone
Dexamethasone is taken orally in tablet form or administered intravenously. It is used in combination with other medications to treat multiple myeloma. Dexamethasone works by reducing inflammation and suppressing the immune response, which helps control cancer cell growth. 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. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to symptoms such as bone pain, anemia, and kidney problems. As the disease progresses, it can cause bone damage, increased risk of infections, and high levels of calcium in the blood. The abnormal plasma cells produce a protein that can cause damage to the kidneys and other organs. Over time, the disease can lead to complications such as bone fractures and severe anemia. It is most commonly diagnosed in older adults and can vary in its rate of progression.