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

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What is this study about?

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.

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 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 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 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 Study?

  • 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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Cczxce Htkchhthukj Ryfjzxap Ublyxnxcrzfku Dx Tynel Tours France
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Hglsjavt Ugzcjgqqufcaim Siatfriqjc &cgugwl Hquhxda dp Hypjdyvbvbe STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
02.03.2022

Trial locations

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.

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 ID:
2024-515037-15-00
Protocol code:
APHP190205
NCT ID:
NCT05054478
Trial Phase:
Therapeutic exploratory (Phase II)

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