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Study on the Effectiveness and Safety of Bortezomib and Daratumumab for Patients with Primary Plasma Cell Leukemia

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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 a rare type of blood cancer called primary plasma cell leukemia. The study aims to evaluate the effectiveness and safety of a treatment plan that includes alternating regimens based on the drug bortezomib, combined with another medication called daratumumab. The treatment plan also includes a maintenance phase where only daratumumab is used. Bortezomib is administered as a powder for solution for injection, while daratumumab is given as a solution for injection. Other medications involved in the study include doxorubicin hydrochloride, dexamethasone sodium phosphate, and cyclophosphamide.

The purpose of the study is to assess how well this combination of treatments works in patients who have not received any prior treatment for their condition. The study will follow a specific course where patients will receive the alternating bortezomib-based regimens in combination with daratumumab, followed by a consolidation phase with daratumumab and other medications, and finally a maintenance phase with daratumumab alone. The study will monitor the patients over a period to see how long they remain free from disease progression.

Participants in the study will receive the medications through different methods, such as subcutaneous use (under the skin), intravenous use (into a vein), and oral use (by mouth). The study is designed to provide valuable information on the potential benefits and safety of this treatment approach for primary plasma cell leukemia, helping to improve future treatment options for this challenging condition.

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 first stage of the clinical trial involves the induction treatment. During this phase, you will receive a combination of medications to treat primary plasma cell leukemia. The medications include bortezomib, daratumumab, doxorubicin hydrochloride, dexamethasone sodium phosphate, and cyclophosphamide.

    The medications are administered in different ways: bortezomib and daratumumab are given through subcutaneous injections, doxorubicin hydrochloride is given intravenously, and dexamethasone sodium phosphate and cyclophosphamide are taken orally. The specific dosage and frequency will be determined by the medical team based on your individual needs.

  2. Step 2

    Consolidation treatment

    After completing the induction treatment, you will move on to the consolidation treatment phase. This phase continues to use the combination of medications to further treat the leukemia.

    The goal of this phase is to consolidate the response achieved during the induction phase. The same medications and administration methods are used, and the medical team will monitor your progress closely.

  3. Step 3

    Maintenance treatment

    Following the consolidation treatment, you will enter the maintenance treatment phase. In this phase, you will receive daratumumab as a monotherapy to help maintain the response to the treatment.

    Daratumumab will be administered through subcutaneous injections. The frequency and duration of this phase will be determined by the medical team based on your response to the previous treatments.

  4. Step 4

    Monitoring and follow-up

    Throughout the clinical trial, regular monitoring and follow-up visits will be scheduled. These visits are important to assess your response to the treatment and to monitor for any side effects.

    During these visits, various tests and assessments will be conducted to ensure your safety and to evaluate the effectiveness of the treatment. The medical team will provide guidance and support throughout the trial.

Who can join the trial?

21 criteria

  • Patients must be between 18 and 80 years old.
  • Both females and males of any race or ethnicity can participate.
  • If you are a female who can have children, you must:
    • Be willing to use an acceptable form of birth control.
    • Agree not to donate eggs during the study.
    • Have two negative pregnancy tests before starting the study.
    • If you are a male who can father children and are sexually active with females who can have children, you must:
      • Always use a latex or synthetic condom during the study and for 3 months after stopping the study treatment, even if you have had a vasectomy.
      • Agree not to donate sperm during the study and for 3 months after the last dose of study treatment.
      • You must be able to understand and follow the study requirements, including attending scheduled visits.
      • You or your legal representative must be able to understand and sign a consent form before any study-related procedures are done.
      • You must be newly diagnosed with primary plasma cell leukemia (pPCL) and meet specific medical criteria for this condition.
      • You must have a measurable disease as defined by specific protein levels in your blood or urine.
      • You should be eligible for high-dose therapy, with or without stem cell transplantation, as part of your treatment plan.
      • You must not have been treated with any systemic therapy or stem cell transplant for any plasma cell disorder, except for a short course of corticosteroid therapy.
      • You must have adequate bone marrow function, which means:
        • Hemoglobin level of at least 7.0 g/dL.
        • Absolute neutrophil count (ANC) of at least 1.0 x 109/L.
        • Platelet count of at least 50 x 109/L if more than 50% of your bone marrow is involved with the disease; otherwise, at least 75 x 109/L.
        • You must have adequate liver function, which means:
          • Serum Aspartate Transaminase (AST) level no more than 2.5 times the upper limit of normal (ULN).
          • Serum Alanine Aminotransferase (ALT) level no more than 2.5 times the ULN.
          • Total bilirubin level no more than 1.5 times the ULN.
          • You must have adequate kidney function, with an estimated creatinine clearance (CrCl) of at least 20 mL/min.
          • Your performance status, which measures your ability to perform daily activities, must be between 0 and 3 on the Eastern Cooperative Oncology Group (ECOG) scale.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer, except for primary plasma cell leukemia, cannot participate.
  • Patients who have had a heart attack or severe heart problems in the past 6 months are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with severe liver disease are excluded.
  • Patients with severe kidney disease are not allowed to participate.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with active infections that require treatment are not eligible.
  • Patients who have received another investigational drug within the last 30 days cannot participate.
  • Patients with known allergies to the study drugs are excluded.
  • Patients with a history of drug or alcohol abuse in the past year are not eligible.
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Investigated drugs

  • Bortezomib

    is a medication used in this trial to help treat a type of blood cancer called primary plasma cell leukemia. It works by blocking certain proteins in cancer cells, which can slow down or stop their growth. This medication is part of the treatment plan to help control the disease.

  • Daratumumab

    is another medication used in this trial. It is a type of therapy that targets specific proteins on the surface of cancer cells. By doing this, it helps the body's immune system to find and destroy these cancer cells. In this study, daratumumab is used both in combination with other treatments and on its own to help maintain the results of the initial treatment.

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 medical practice and literature for treating certain types of blood cancers, including primary plasma cell leukemia. The main therapeutic indication for Bortezomib is to help control the growth of cancer cells. At the molecular level, it works by blocking the action of proteasomes, which are structures inside cells that break down proteins, leading to cancer cell death. Bortezomib is classified as a proteasome inhibitor.

  • Daratumumab

    Daratumumab is given as an injection, usually administered into a vein. It is well-established in medical literature and is used to treat multiple myeloma and primary plasma cell leukemia. The main therapeutic indication for Daratumumab is to target and destroy cancer cells. It works by attaching to a specific protein on the surface of cancer cells, called CD38, which helps the immune system recognize and kill these cells. Daratumumab is classified as a monoclonal antibody.

Investigated diseases

Primary plasma cell leukemia – Primary plasma cell leukemia is a rare and aggressive form of leukemia characterized by the presence of a high number of plasma cells in the blood. It originates from the bone marrow, where plasma cells, a type of white blood cell, are produced. The disease progresses rapidly, with plasma cells circulating in the bloodstream and infiltrating various organs. This infiltration can lead to organ dysfunction and other complications. As the disease advances, it can cause symptoms such as fatigue, bone pain, and increased susceptibility to infections. The progression of primary plasma cell leukemia is marked by the rapid increase in abnormal plasma cells, which can disrupt normal blood cell production.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518263-35-00Protocol code54767414LEU2002Estimated enrolment43 patientsSponsorHellenic Society Of Hematology

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