Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone for Patients with High-Risk Smoldering Multiple Myeloma

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 condition known as Smoldering Multiple Myeloma, which is a precursor to a type of blood cancer called Multiple Myeloma. The study aims to compare the effectiveness of two treatment combinations for patients with high-risk smoldering multiple myeloma. One group of patients will receive a combination of three medications: Carfilzomib (also known by its code name PR-171), Lenalidomide, and Dexamethasone. The other group will receive only Lenalidomide and Dexamethasone. The purpose of the study is to evaluate how well these treatments work in preventing the progression of the disease.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will involve several cycles of treatment, and the progress of the disease will be monitored throughout. The study will assess the response to treatment after nine cycles, and patients will be followed up to see how long they remain free from disease progression. The study will also look at the overall response rate, which means how many patients show at least a partial improvement in their condition, and the safety of the treatment combinations.

The trial will use a method called next-generation flow cytometry to measure the presence of cancer cells in the bone marrow. This method helps determine if the treatment is effective in reducing the number of cancer cells. The study will also explore the relationship between the reduction of cancer cells and the length of time patients remain free from disease progression. The safety of the treatment will be closely monitored, including any side effects that may occur. The study is expected to continue until early 2029, providing valuable information on the best treatment approach for high-risk smoldering multiple myeloma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two treatment groups. The first group will receive a combination of carfilzomib, lenalidomide, and dexamethasone. The second group will receive lenalidomide and dexamethasone only.

  2. Step 2

    Treatment cycle 1 to 9

    For the group receiving carfilzomib, lenalidomide, and dexamethasone:

    The patient will receive carfilzomib intravenously. The specific dosage and frequency will be determined by the study protocol.

    The patient will take lenalidomide orally in capsule form. The dosage will vary between 5 mg, 10 mg, 15 mg, and 25 mg, depending on the cycle and the patient's response.

    The patient will take dexamethasone orally in tablet form. The dosage will vary between 2 mg, 4 mg, and 8 mg, depending on the cycle and the patient's response.

    For the group receiving lenalidomide and dexamethasone:

    The patient will take lenalidomide orally in capsule form. The dosage will vary between 5 mg, 10 mg, 15 mg, and 25 mg, depending on the cycle and the patient's response.

    The patient will take dexamethasone orally in tablet form. The dosage will vary between 2 mg, 4 mg, and 8 mg, depending on the cycle and the patient's response.

  3. Step 3

    Evaluation after cycle 9

    After completing 9 cycles, the patient's response to the treatment will be evaluated. The main goal is to assess the rate of minimal residual disease (MRD) negativity using next-generation flow cytometry. This evaluation helps determine the effectiveness of the treatment.

  4. Step 4

    Maintenance phase

    If the patient achieves a successful response, they may enter a maintenance phase. During this phase, the treatment regimen may be adjusted based on the patient's condition and response to the initial cycles.

  5. Step 5

    Ongoing monitoring

    Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular assessments of disease progression, overall survival, and any side effects experienced.

Who can join the trial?

11 criteria

  • Patients must have a confirmed diagnosis of **Smoldering Multiple Myeloma**. This means they have a specific type of blood cancer that is not yet causing symptoms.
  • Patients must provide **written informed consent**, which means they agree to participate in the study after understanding all the details.
  • Patients must have a **Creatinine Clearance** of at least 50 ml/min. This is a test to check how well the kidneys are working.
  • Patients must be able to give informed consent, meaning they understand the study and agree to participate.
  • Patients must have **high-risk Smoldering Multiple Myeloma** according to specific medical criteria.
  • Patients must have a **measurable disease**, meaning the disease can be measured or tracked by doctors.
  • Patients must be over 18 years old.
  • Patients must have a **WHO/ECOG performance status** of 2 or less. This is a scale that measures how well a patient can perform daily activities.
  • Patients must have normal organ and bone marrow function, meaning their organs and bone marrow are working properly.
  • Patients must be willing and able to use **adequate contraception** during and after the therapy. This applies to all men and premenopausal women to prevent pregnancy during the study.
  • Females who can have children must have a negative pregnancy test before starting the treatment and again within 24 hours of starting **lenalidomide** treatment, which is a medication used in the study.

Who cannot join the trial?

8 criteria

  • Patients with any other serious medical condition that could interfere with the study.
  • Patients who have had another type of cancer in the past, unless it was treated and cured.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have an active infection that requires treatment.
  • Patients with a history of allergic reactions to the study medications.
  • Patients who have a mental health condition that could affect their ability to participate in the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Carfilzomib

    is a medication used in this trial to treat high-risk smoldering multiple myeloma. It works by blocking certain proteins in cancer cells, which can help stop the growth and spread of the cancer.

  • Lenalidomide

    is another medication used in the trial. It helps the immune system attack cancer cells and can also stop the growth of new blood vessels that tumors need to grow.

  • Dexamethasone

    is a steroid used in the trial to reduce inflammation and help control the immune system. It can also help enhance the effects of other cancer treatments.

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 high-risk smoldering multiple myeloma and multiple myeloma. It is a proteasome inhibitor, which means it works by blocking the action of proteasomes, cellular complexes that break down proteins. By inhibiting these proteasomes, carfilzomib causes an accumulation of proteins within the cell, leading to cell death, particularly in cancer cells. It is classified as an antineoplastic agent.

  • Lenalidomide

    Lenalidomide is taken orally in capsule form and is widely used in the treatment of multiple myeloma and other blood disorders. It is an immunomodulatory drug that works by enhancing the immune system's ability to fight cancer, inhibiting the growth of cancer cells, and reducing the formation of blood vessels that supply tumors. Lenalidomide is classified as an immunomodulatory agent.

  • Dexamethasone

    Dexamethasone is administered orally or intravenously and is commonly used in combination with other medications to treat multiple myeloma. It is a corticosteroid that reduces inflammation and suppresses the immune response, helping to alleviate symptoms and enhance the effectiveness of other cancer treatments. Dexamethasone is classified as a glucocorticoid.

Investigated diseases

  • Smoldering Multiple Myeloma

    This is a condition characterized by the presence of abnormal plasma cells in the bone marrow, which are not yet causing symptoms or organ damage. It is considered an early or asymptomatic form of multiple myeloma. Over time, the condition may progress to active multiple myeloma, but it remains stable in some individuals for many years. Monitoring is essential to detect any signs of progression to symptomatic disease. The progression involves an increase in the number of abnormal plasma cells and potential development of symptoms.

  • Multiple Myeloma

    This is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. It leads to the production of abnormal proteins that can cause damage to bones, kidneys, and the immune system. The disease progresses as these abnormal cells multiply, leading to bone pain, fractures, anemia, and increased risk of infections. Over time, the accumulation of these cells can cause significant health issues, including organ damage. The progression is typically marked by worsening symptoms and increased levels of abnormal proteins in the blood or urine.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511334-12-00Protocol codeHO147Estimated enrolment58 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.