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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Ospedale Generale Provinciale Di Macerata Macerata Italy
Azienda Sanitaria Locale Di Pescara Pescara Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
Azienda Ospedaliera Papardo Messina Italy
Azienda Ospedaliera di Padova Padua Italy
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Politecnica Delle Marche Ancona Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
ARNAS G. Brotzu Cagliari Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Universita Degli Studi Di Brescia Brescia Italy
Azienda Ulss 6 Euganea Padua Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
01.05.2018

Trial locations

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.

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.

Trial ID:
2024-512049-17-00
Protocol code:
Real MM
NCT ID:
NCT03829371
Trial Phase:
Therapeutic confirmatory (Phase III)

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