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Study on Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma

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 Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is investigating the effectiveness of a combination of treatments, including Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone. Elotuzumab is a monoclonal antibody, which is a type of protein designed to target specific cells, while Carfilzomib is a medication that helps to stop the growth of cancer cells. Lenalidomide is an immunomodulating agent, meaning it helps to regulate the immune system, and Dexamethasone is a steroid that reduces inflammation and suppresses the immune system.

The purpose of this study is to compare the effectiveness of two different treatment regimens in patients who have been newly diagnosed with Multiple Myeloma. One group will receive a combination of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone, while the other group will receive Carfilzomib, Lenalidomide, and Dexamethasone without Elotuzumab. The study will also look at how well patients do after receiving an autologous stem cell transplant, which is a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow.

Participants in the study will receive treatment over a period of time and will be monitored to see how their disease responds. The study will also assess the long-term effects of the treatments, including how long patients remain free from disease progression. This research aims to improve understanding of how these treatments can be used to manage Multiple Myeloma and to determine the best approach for maintaining health after initial treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. You will be required to sign a consent form, confirming your understanding and willingness to participate.

  2. Step 2

    Induction phase

    During the induction phase, you will receive a combination of medications. These include elotuzumab, carfilzomib, lenalidomide, and dexamethasone. Elotuzumab and carfilzomib are administered through an intravenous infusion, which means they are given directly into your vein. Lenalidomide and dexamethasone are taken orally as capsules.

    This phase involves six cycles of treatment. Each cycle lasts for a specific period, during which you will receive the medications at set intervals. The goal is to achieve a very good partial response or better, as assessed by specific criteria.

  3. Step 3

    Autologous stem cell transplant

    Following the induction phase, you may undergo an autologous stem cell transplant. This procedure involves collecting your own stem cells, which are then returned to your body after intensive treatment. This step is aimed at further reducing the disease burden.

  4. Step 4

    Consolidation phase

    After the transplant, you will enter the consolidation phase. This phase involves additional cycles of the same combination of medications to strengthen the response achieved during the induction phase.

  5. Step 5

    Maintenance phase

    In the maintenance phase, you will continue to receive lenalidomide and elotuzumab to help maintain the response and prevent disease progression. Lenalidomide is taken orally, while elotuzumab is administered intravenously.

    The duration of this phase is determined by your response to the treatment and overall health status. Regular assessments will be conducted to monitor your condition.

  6. Step 6

    Follow-up and monitoring

    Throughout the trial, you will undergo regular follow-up visits. These visits are essential for monitoring your health, assessing the effectiveness of the treatment, and managing any side effects.

    You will be required to provide blood samples and undergo various tests as part of the monitoring process. Your healthcare team will guide you through each step and address any concerns you may have.

Who can join the trial?

14 criteria

  • Adults aged between 18 and 70 years old.
  • Must be able to understand the purpose and risks of the study and be willing to participate, providing written consent.
  • Females must understand the risks of the medication lenalidomide to an unborn baby and agree to follow a pregnancy prevention plan.
  • Males must understand the risks of the medication to a pregnant partner or a female who can become pregnant and agree to use protection or practice complete abstinence during the study and for a specified period after.
  • Must not donate blood or semen while taking lenalidomide and for a specified period after the last dose.
  • Must agree not to share lenalidomide with others and return any unused capsules to the study team.
  • Eligible for a procedure called autologous stem cell transplantation (ASCT), which involves using your own stem cells for treatment.
  • Must not have received any prior treatment for multiple myeloma, except for certain allowed treatments like dexamethasone, a type of steroid.
  • Must have newly diagnosed multiple myeloma, meeting specific medical criteria.
  • Must have measurable disease parameters, which means certain levels of specific proteins in the blood or urine.
  • Must have an ECOG Performance Status of 0, 1, or 2, which is a scale used to assess how the disease affects daily living abilities.
  • Must have a heart function test called echocardiography showing a left ventricular ejection fraction (LVEF) of 50% or higher, indicating how well the heart pumps blood.
  • Must have certain laboratory test results within specified ranges, such as white blood cell count, platelet count, and kidney function.
  • Must be legally capable of giving consent to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who have not been newly diagnosed with Multiple Myeloma cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who have a history of certain types of cancer other than Multiple Myeloma may not be eligible.
  • Patients who have active infections that require treatment cannot participate.
  • Patients who have a history of drug or alcohol abuse may not be eligible.
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Investigated drugs

  • Elotuzumab

    is a type of medication known as a monoclonal antibody. It works by helping your immune system find and attack cancer cells. In this trial, it is used in combination with other medications to treat multiple myeloma, a type of blood cancer. Elotuzumab is given to help improve the effectiveness of the treatment and to maintain the response to therapy over time.

  • Carfilzomib

    is a medication that belongs to a class of drugs called proteasome inhibitors. It works by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting proteasomes, carfilzomib helps to kill cancer cells and slow down the progression of multiple myeloma.

  • Lenalidomide

    is a medication that modifies the immune system and has anti-cancer effects. It helps to slow the growth of cancer cells and can also enhance the immune system's ability to fight cancer. In this trial, lenalidomide is used both in combination with other drugs and as a single agent during the maintenance phase to help keep the cancer under control.

  • Dexamethasone

    is a type of corticosteroid medication. It is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma treatment, dexamethasone helps to enhance the effects of other cancer treatments and can also help manage some of the symptoms associated with the disease.

What is already known about the treatment

Elotuzumab – Elotuzumab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating newly diagnosed multiple myeloma, a type of blood cancer. The medication works by targeting a specific protein on the surface of certain immune cells, helping the body's immune system to attack and destroy cancer cells. Elotuzumab is classified as a monoclonal antibody, which is a type of drug designed to bind to specific proteins in the body.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that originates in the plasma cells, which are a type of white blood cell found in the bone marrow. As the disease progresses, abnormal plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. This can result in symptoms such as bone pain, anemia, and increased susceptibility to infections. Over time, the disease can cause damage to bones and kidneys, and may lead to high levels of calcium in the blood. The progression of Multiple Myeloma is typically characterized by periods of stability followed by relapses, where the disease becomes more active. The disease is considered chronic and can vary greatly in its rate of progression among different individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515783-31-00Protocol codeDSMM_XVIIEstimated enrolment574 patientsSponsorUniversitaetsklinikum Wuerzburg AöR

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