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Study on Daratumumab, Lenalidomide, and Dexamethasone for Patients with Primary Plasma Cell Leukemia

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 a rare type of blood cancer called Primary Plasma Cell Leukemia. The study involves a combination of treatments, including a medication called Darzalex (daratumumab), which is given as an injection, and Revlimid (lenalidomide), which is taken as capsules. Other medications used in the study include Dexamethasone, which can be administered either as an injection or an oral solution, and Bortezomib, which is given as an injection. The purpose of the study is to determine the best overall response rate after the initial treatment phase.

Participants in the study will receive these treatments over a period of time, with the aim of understanding how well the combination works in treating the disease. The study will also look at how long patients live without the disease getting worse, overall survival rates, and the duration of response to the treatment. Additionally, the study will assess the safety of the treatments by monitoring any side effects and changes in health indicators.

The study will also evaluate the response to treatment based on specific genetic changes in the cancer cells, such as del(17p) and t(4;14). Another aspect of the study is to assess the quality of life of participants using a questionnaire known as EORTC QLQ-C30. The study is expected to continue until 2028, providing valuable insights into the effectiveness and safety of the treatment combination for Primary Plasma Cell Leukemia.

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

    The induction phase involves the administration of several medications to manage primary plasma cell leukemia.

    Medications include lenalidomide (Revlimid) taken orally in capsule form, with dosages of 10 mg and 5 mg. The specific dosage and frequency will be determined by the healthcare provider.

    Daratumumab (DARZALEX) is administered as a subcutaneous injection. The frequency and duration of administration will be specified by the healthcare provider.

    Dexamethasone is given intravenously and orally. The exact dosage and schedule will be provided by the healthcare team.

    Bortezomib is administered subcutaneously. The healthcare provider will determine the dosage and frequency.

  2. Step 2

    Stem cell transplantation

    Following the induction phase, eligible patients may undergo a stem cell transplantation procedure.

    This step involves the use of high-dose chemotherapy, specifically Melphalan, to prepare the body for the transplantation.

  3. Step 3

    Post-transplantation monitoring

    After the stem cell transplantation, regular monitoring is conducted to assess the response to treatment.

    This includes evaluating the overall response rate and monitoring for any adverse effects or complications.

  4. Step 4

    Follow-up and evaluation

    The follow-up phase involves ongoing assessments to determine progression-free survival, overall survival, and duration of response.

    Quality of life is also evaluated using specific questionnaires designed to measure health-related quality of life.

Who can join the trial?

18 criteria

  • Male or female patients aged 18 to 69 years old.
  • Levels of certain liver enzymes, called alanine aminotransferase (ALT) and aspartate aminotransferase (AST), should be no more than 3 times the normal limit.
  • Creatinine clearance, a measure of kidney function, should be at least 20 mL/min. This is calculated using a specific formula.
  • Female patients must meet one of the following conditions:
    • Have been postmenopausal for at least 2 years before the screening visit.
    • Are surgically sterile.
    • If they can have children, they must agree to use two effective methods of birth control at the same time from signing the consent form until 90 days after the last dose of the study drug.
    • Agree to practice true abstinence if it aligns with their lifestyle. Note that periodic abstinence and withdrawal are not acceptable methods.
    • Must be part of an appropriate social security system.
    • Male patients, even if surgically sterilized, must agree to one of the following:
      • Use effective barrier contraception during the study and for 90 days after the last dose of the study drug.
      • Practice true abstinence if it aligns with their lifestyle. Periodic abstinence and withdrawal are not acceptable methods.
      • Patients must agree not to share the study medication with others and to return any unused study drugs to the investigator.
      • Must agree not to donate blood while taking the study drug and for one week after stopping the study drug.
      • Must be able to follow the study visit schedule and other study requirements.
      • Must have primary plasma cell leukemia with at least 5% circulating plasma cells in the blood, as defined by recent guidelines.
      • Must provide voluntary written consent before any study-related procedures that are not part of standard medical care. Consent can be withdrawn at any time without affecting future medical care.
      • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which is a measure of how well they can perform daily activities.
      • Must be eligible for high-dose Melphalan therapy with autologous stem cell transplantation (ASCT).
      • Total bilirubin levels, a measure of liver function, should be no more than 2 times the normal limit.
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Investigated drugs

  • Daratumumab

    is a medication used in this trial to treat primary plasma cell leukemia. It is a type of targeted therapy known as a monoclonal antibody. Daratumumab works by attaching to a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells.

  • Chemotherapy

    is a treatment that uses powerful drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is combined with other treatments to enhance its effectiveness against primary plasma cell leukemia.

  • Stem Cell Transplantation

    is a procedure used to replace damaged or destroyed bone marrow with healthy stem cells. In this trial, it is used after chemotherapy to help restore the bone marrow's ability to produce healthy blood cells.

What is already known about the treatment

Daratumumab – This medication is administered intravenously and is used in combination with chemotherapy and stem cell transplantation. It is currently being studied in a Phase II clinical trial for its effectiveness in treating primary plasma cell leukemia. Daratumumab is primarily indicated for multiple myeloma and related conditions. It works by targeting a specific protein on the surface of cancer cells, leading to their destruction. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Primary Plasma Cell Leukemia – This 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, become cancerous and multiply uncontrollably. The disease progresses rapidly, often leading to symptoms such as fatigue, bone pain, and frequent infections due to the compromised immune system. As the abnormal plasma cells increase, they can cause damage to bones and impair kidney function. The condition is distinct from multiple myeloma, another plasma cell disorder, due to its more aggressive nature and the presence of plasma cells in the bloodstream. Early detection and intervention are crucial to managing the disease's progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515037-15-00Protocol codeAPHP190205Estimated enrolment29 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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