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Study on Carfilzomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous 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 have been newly diagnosed with this condition and are eligible for a procedure called an autologous transplant, where a patient's own stem cells are used to replace damaged or diseased bone marrow.

The trial will test different combinations of medications to see how well they work in treating Multiple Myeloma. The medications being studied include Carfilzomib, Lenalidomide, Cyclophosphamide, and Dexamethasone. Carfilzomib is given as an infusion, which means it is administered directly into the bloodstream through a vein, while Lenalidomide, Cyclophosphamide, and Dexamethasone are taken orally in capsule form. The study will compare the effectiveness of these medications when used in different combinations and treatment plans, including before and after the transplant, or as a continuous treatment without a transplant.

The purpose of the study is to determine how effective these medication combinations are in achieving a significant reduction in cancer cells, known as a very good partial response, after four cycles of treatment. The study will also look at how long patients remain free from disease progression during the maintenance phase, where treatment is continued to help keep the cancer from returning. Participants will be monitored throughout the study to assess the outcomes of the different treatment approaches.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction treatment

    The induction phase involves the administration of medications to prepare for potential transplant. Two different combinations of drugs are used: carfilzomib, lenalidomide, and dexamethasone or carfilzomib, cyclophosphamide, and dexamethasone.

    The treatment is administered over 4 cycles. Carfilzomib is given intravenously, while lenalidomide and cyclophosphamide are taken orally in capsule form.

  2. Step 2

    Transplant and consolidation

    For patients eligible for a transplant, an autologous stem cell transplant may be performed. This involves using the patient's own stem cells to help restore bone marrow function.

    Following the transplant, a consolidation phase occurs, which involves further treatment with the same drug combinations used in the induction phase to strengthen the response to treatment.

  3. Step 3

    Continuous treatment

    For patients not undergoing a transplant, continuous treatment with carfilzomib, lenalidomide, and dexamethasone is administered over 12 cycles.

    This phase aims to maintain the response achieved during the induction phase.

  4. Step 4

    Maintenance treatment

    After the consolidation or continuous treatment phase, maintenance therapy begins. This involves the use of lenalidomide alone or in combination with carfilzomib.

    The goal of maintenance therapy is to prolong the period of remission and prevent disease progression.

Who can join the trial?

15 criteria

  • Must be **18 years or older**.
  • Must have been **newly diagnosed with Multiple Myeloma (MM)**, a type of blood cancer.
  • Must be **eligible for autologous stem cell transplant (ASCT)**, a procedure where a patient's own stem cells are used.
  • Must have a **measurable disease** according to specific medical guidelines.
  • Must provide **voluntary written informed consent**, meaning you agree to participate after understanding the study.
  • Must agree to use **acceptable methods of contraception** to prevent pregnancy during the study.
  • Must have a **Karnofsky performance status of 60% or higher**, which is a way to measure your ability to perform daily activities.
  • Must have certain **clinical laboratory values** within normal ranges, such as:
    • **Platelet count** of at least 75 x 109/L (or 50 x 109/L if more than 50% of bone marrow is affected by myeloma).
    • **Absolute neutrophil count (ANC)** of at least 1 x 109/L without using growth factors.
    • **Corrected serum calcium** of 14 mg/dL or less.
    • **Alanine transaminase (ALT)** and **Aspartate transaminase (AST)** levels no more than 3 times the upper limit of normal (ULN).
    • **Total bilirubin** no more than 2 times the ULN.
    • **Creatinine clearance** of at least 30 mL/minute, which measures kidney function.
    • **Left ventricular ejection fraction (LVEF)** of at least 40%, which measures heart function.
    • Must have a **life expectancy of at least 3 months**.

Who cannot join the trial?

4 criteria

  • Patients who have not been newly diagnosed with **Multiple Myeloma (MM)**. **Multiple Myeloma** is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not eligible for an **autologous transplant**. An **autologous transplant** is a procedure where a patient's own stem cells are used to replace damaged or diseased bone marrow.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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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 proteasomes, which are structures inside cells that break down proteins. By inhibiting these proteasomes, carfilzomib causes cancer cells to die.

  • Cyclophosphamide

    is a chemotherapy drug that is used to treat various types of cancer, including multiple myeloma. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

  • Dexamethasone

    is a type of steroid medication that is often used in combination with other drugs to treat multiple myeloma. It helps reduce inflammation and can also help kill cancer cells.

  • Lenalidomide

    is a medication that modifies the immune system and has anti-cancer effects. It is used to treat multiple myeloma by helping the immune system attack cancer cells and by directly inhibiting their growth.

What is already known about the treatment

  • Carfilzomib

    Carfilzomib is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating newly diagnosed multiple myeloma patients eligible for autologous transplant. It is primarily used in combination with other medications like dexamethasone, cyclophosphamide, or lenalidomide. Carfilzomib 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.

  • Cyclophosphamide

    Cyclophosphamide is given orally or intravenously and is a well-established medication in the treatment of various cancers, including multiple myeloma. In the context of this trial, it is used in combination with carfilzomib and dexamethasone. Cyclophosphamide works by interfering with the DNA replication process in cancer cells, preventing their growth and division. It is classified as an alkylating agent.

  • Dexamethasone

    Dexamethasone is administered orally or intravenously and is widely used in cancer treatment protocols, including for multiple myeloma. It is used in combination with carfilzomib and either cyclophosphamide or lenalidomide in this trial. Dexamethasone is a corticosteroid that helps reduce inflammation and suppresses the immune response, which can help control cancer cell growth. It is classified as a glucocorticoid.

  • Lenalidomide

    Lenalidomide is taken orally and is a key medication in the treatment of multiple myeloma, often used in combination with other drugs. In this trial, it is combined with carfilzomib and dexamethasone. Lenalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory agent.

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 bones to become weak and more prone to fractures. Patients may also experience frequent infections due to a weakened immune system. Over time, the accumulation of abnormal proteins produced by the cancerous cells can lead to organ damage. The disease typically progresses in stages, with symptoms worsening as the number of cancerous cells increases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516630-35-01Protocol code2024-516630-35-00Estimated enrolment477 patientsSponsorUniversita' Degli Studi Di Torino

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