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Study Comparing Daratumumab with Drug Combination for Young Patients with Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplantation

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 young patients who have been newly diagnosed with this condition and are eligible for a procedure called autologous stem cell transplantation, which uses the patient's own stem cells to help restore healthy bone marrow. The trial aims to compare two different treatment combinations before and after the transplantation. One group will receive a combination of daratumumab, bortezomib, cyclophosphamide, and dexamethasone (referred to as Dara-VCd), while the other group will receive bortezomib, thalidomide, and dexamethasone (referred to as VTd). After the transplantation, both groups will undergo a maintenance phase with ixazomib, either alone or combined with daratumumab.

The purpose of the study is to determine how well these treatments work in preventing the progression of multiple myeloma over a period of time. The study will also look at how many patients achieve a state called minimal residual disease negativity, which means that very few cancer cells are left in the body after treatment. This will be assessed using a method called next generation sequencing, which is a way to analyze genetic material in detail. The trial will last for several years, with regular assessments to monitor the effectiveness of the treatments.

Participants in the study will receive their treatments either orally or through injections, depending on the specific medication. The trial is designed to provide valuable information on the best treatment strategies for young patients with multiple myeloma, helping to improve outcomes and quality of life. The study is conducted in multiple centers, allowing for a comprehensive evaluation of the treatments across different patient populations.

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 phase

    During the induction phase, two treatment options are available: daratumumab combined with bortezomib, cyclophosphamide, and dexamethasone (Dara-VCd) or the combination of bortezomib, thalidomide, and dexamethasone (VTd).

    Daratumumab is administered as a subcutaneous injection. Bortezomib is given as a subcutaneous injection. Cyclophosphamide is taken orally. Dexamethasone is taken orally.

    Thalidomide is taken orally. The duration of this phase is determined by the study protocol.

  2. Step 2

    Transplantation

    Following the induction phase, eligible patients undergo an autologous stem cell transplantation. This involves collecting the patient's own stem cells, which are then reintroduced after high-dose chemotherapy.

  3. Step 3

    Consolidation phase

    After transplantation, the consolidation phase begins. Patients continue with the same treatment regimen as in the induction phase to strengthen the response to treatment.

    The duration of this phase is specified in the study protocol.

  4. Step 4

    Maintenance phase

    In the maintenance phase, patients receive ixazomib alone or in combination with daratumumab to maintain the treatment response.

    Ixazomib is taken orally. The duration of this phase is determined by the study protocol.

Who can join the trial?

25 criteria

  • Patient must be between 18 and 65 years old.
  • Women who can have children must agree to use two reliable birth control methods or abstain from heterosexual intercourse. This includes one highly effective method like birth control pills or an intrauterine device, and one additional method like a condom. This must start before taking the study drugs and continue for a specific time after the last dose.
  • Men must agree to use a condom or abstain from sex during the study and for a specific time after the last dose of study drugs.
  • Patient must have a certain level of physical activity, measured by a score called ECOG or Karnofsky performance status.
  • Patient must have certain blood test results within 30 days before joining the study, including:
    • Platelet count of at least 75 x 109 per liter.
    • Absolute neutrophil count (ANC) of at least 1 x 109 per liter.
    • Corrected serum calcium less than 14 mg/dL.
    • Aspartate transaminase (AST) and alanine transaminase (ALT) levels not more than 2.5 times the normal limit.
    • Total bilirubin not more than 1.5 times the normal limit.
    • Creatinine clearance of at least 30 mL per minute.
    • Patient must have a life expectancy of more than 3 months.
    • Patient must be eligible for a procedure called ASCT, which involves using their own stem cells.
    • Patient must have a heart function measurement called LVEF of at least 40%, checked by a test called an echocardiogram or MUGA scan.
    • Patient must be newly diagnosed with multiple myeloma.
    • Patient must provide written consent to participate in the study, understanding they can withdraw at any time.
    • Patient must have documented multiple myeloma with measurable disease, which means:
      • Monoclonal plasma cells in the bone marrow of at least 10% or a biopsy-proven plasmacytoma.
      • Measurable disease with specific protein levels in the blood or urine.
      • Patient must show evidence of organ damage or specific markers of cancer, such as:
        • High calcium levels in the blood.
        • Kidney problems with low creatinine clearance or high serum creatinine.
        • Low hemoglobin levels indicating anemia.
        • Bone lesions visible on imaging tests.
        • Patient must have one or more specific markers of cancer, such as:
          • High percentage of clonal plasma cells in the bone marrow.
          • Abnormal serum free light chain ratio.
          • More than one focal lesion on MRI studies.
          • Patient must be willing and able to follow the study requirements, according to the investigator's opinion.

Who cannot join the trial?

5 criteria

  • Patients who are not diagnosed with Multiple Myeloma (MM), a type of blood cancer.
  • Patients who are not eligible for the autologous transmission of stem cells, which is a procedure where a patient's own stem cells are collected and then given back to them after treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements, as the study includes both male and female participants.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Daratumumab

    is a medication used in this trial to treat multiple myeloma. It is an antibody that helps the immune system to find and destroy cancer cells. In this study, it is combined with other drugs to enhance its effectiveness in treating the disease.

  • Bortezomib

    is a drug that interferes with the growth of cancer cells and slows their spread in the body. It is used in combination with other medications in this trial to treat multiple myeloma.

  • Cyclophosphamide

    is a chemotherapy medication that works by slowing or stopping the growth of cancer cells. It is used in this study as part of a combination treatment for multiple myeloma.

  • Dexamethasone

    is a type of steroid that helps reduce inflammation and is used to treat various conditions, including cancer. In this trial, it is used alongside other medications to help treat multiple myeloma.

  • Thalidomide

    is a medication that helps to slow the growth of cancer cells and is used in combination with other drugs in this trial to treat multiple myeloma.

  • Ixazomib

    is a medication that helps to stop the growth of cancer cells. In this study, it is used during the maintenance phase to help keep the cancer from returning after initial treatment.

What is already known about the treatment

  • Daratumumab

    This medication is administered intravenously and is currently used in the treatment of multiple myeloma, particularly in young patients eligible for autologous stem cell transplantation. It is well-documented in medical literature as an effective therapy for this condition. Daratumumab works by targeting a specific protein on the surface of myeloma cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

  • Bortezomib

    Administered via injection, bortezomib is a well-established treatment for multiple myeloma. It is used in combination with other medications to enhance its effectiveness. Bortezomib works by inhibiting the proteasome, a complex that breaks down proteins in cells, leading to cancer cell death. It is classified as a proteasome inhibitor.

  • Cyclophosphamide

    This medication is taken orally or by injection and is used in combination therapies for multiple myeloma. Cyclophosphamide is an alkylating agent that works by interfering with the DNA of cancer cells, preventing their growth and division. It is a well-known chemotherapy drug with a long history of use in cancer treatment.

  • Dexamethasone

    Administered orally or by injection, dexamethasone is a corticosteroid used to reduce inflammation and suppress the immune system in multiple myeloma treatment. It is often used in combination with other cancer therapies to enhance their effectiveness. Dexamethasone works by mimicking the effects of hormones produced by the adrenal glands.

  • Thalidomide

    Taken orally, thalidomide is used in combination with other drugs for the treatment of multiple myeloma. It is known for its ability to modulate the immune system and inhibit the growth of blood vessels that supply tumors. Thalidomide is classified as an immunomodulatory agent.

  • Ixazomib

    This medication is taken orally and is used as a maintenance therapy for multiple myeloma. Ixazomib is a proteasome inhibitor that works by blocking the action of proteasomes, leading to the accumulation of proteins in cancer cells and causing their death. It is part of a newer class of oral cancer therapies.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, patients may experience symptoms such as bone pain, fatigue, frequent infections, and anemia. The accumulation of myeloma cells in the bone marrow can also lead to bone lesions and fractures. Over time, the disease can cause significant organ damage and impair the body's ability to produce healthy blood cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511781-37-00Protocol codeEMN18Estimated enrolment401 patientsSponsorCeska Myelomova Skupina z.s.

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