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Study of Selinexor, Bortezomib, and Lenalidomide with Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant

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 disease called Multiple Myeloma, which is a type of cancer that affects the blood. The study is testing a combination of treatments to see how effective they are for patients who have recently been diagnosed with this condition and are not eligible for a stem-cell transplant. The treatments being tested include Selinexor (also known by its code name KPT-330), Bortezomib, Lenalidomide, and Dexamethasone. These medications are taken either by mouth or through an injection under the skin.

The purpose of the study is to evaluate how well these treatments work together in helping patients with newly diagnosed multiple myeloma. Participants in the study will receive these medications in a specific order and combination over a period of time. The study will last for up to 76 weeks, during which the effectiveness of the treatment will be monitored. Some participants may receive a placebo as part of the study to compare the results with those receiving the actual medications.

Throughout the study, the health and progress of the participants will be closely monitored by healthcare professionals. The study aims to understand the overall response of the disease to the treatment, including any side effects or improvements in symptoms. This information will help in determining the best treatment options for patients with multiple myeloma in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests are performed to ensure adequate liver, kidney, and blood cell function. A pregnancy test is required for women of childbearing potential.

  2. Step 2

    Treatment initiation

    The treatment begins with the administration of selinexor, dexamethasone, and either bortezomib or lenalidomide.

    Selinexor is taken orally, once a week.

    Dexamethasone is taken orally, once a week.

    Bortezomib is administered as a subcutaneous injection, once a week, alternating with lenalidomide which is taken orally, daily for 21 days of a 28-day cycle.

  3. Step 3

    Induction phase

    The induction phase consists of 16 cycles, each lasting 28 days.

    During this phase, the response to treatment is monitored through regular blood tests and assessments.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to identify any side effects.

    Evaluations include blood tests, imaging studies, and assessments of overall health and quality of life.

  5. Step 5

    End of induction

    At the end of the 16 cycles, a comprehensive evaluation is performed to determine the overall response to the treatment.

    The primary goal is to achieve a partial response or better, as defined by specific criteria.

Who can join the trial?

13 criteria

  • Must be older than 18 years.
  • Must have at least a 1-week gap since the last platelet transfusion before the screening platelet test. However, receiving red blood cell (RBC) and/or platelet transfusions during the study is allowed if needed.
  • Female patients who can have children must have a negative pregnancy test at the start. Both these women and men who can father children must use very effective birth control methods during the study and for 3 months after the last treatment dose.
  • Must be able to take preventive blood-thinning medication as recommended by the study.
  • If there are broken bones, infections, or thick blood symptoms at diagnosis, these must be treated before joining the study.
  • Must be willing and able to sign a written consent form, agreeing to participate in the study, following all guidelines.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less. A status of 3 is allowed if it is due to multiple myeloma.
  • Must have newly diagnosed multiple myeloma that requires treatment and can be measured according to specific criteria.
  • Must be considered not suitable for high-dose therapy with a stem-cell transplant by the treating doctor.
  • Must not have received any previous chemotherapy for multiple myeloma. Must not have had radiation therapy to a large part of the pelvis or more than 14 days of steroid treatment for myeloma symptoms.
  • Must have proper liver function within 7 days before starting the study, with specific limits on bilirubin and ALT levels.
  • Must have proper kidney function within 7 days before starting the study, with a specific level of estimated glomerular filtration rate (GFR).
  • Must have proper blood cell production within 7 days before starting the study, with specific levels of neutrophils and platelets. If low blood counts are due to a high number of cancerous plasma cells in the bone marrow, the doctor will decide if the study treatment is suitable.
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Investigated drugs

  • Selinexor

    is a medication used in this trial to treat patients with newly diagnosed multiple myeloma who are not eligible for a transplant. It works by blocking certain proteins in cancer cells, which can help to stop the growth and spread of the cancer.

  • Bortezomib

    is another medication used in this trial. It is a type of chemotherapy that helps to kill cancer cells by interfering with their ability to grow and divide.

  • Lenalidomide

    is also part of the treatment regimen in this trial. It is an immunomodulatory drug that helps the immune system attack cancer cells and can also prevent the growth of new blood vessels that tumors need to grow.

  • Dexamethasone

    is a steroid used in this trial to help reduce inflammation and suppress the immune system. It is often used in combination with other cancer treatments to enhance their effectiveness.

What is already known about the treatment

  • Selinexor

    Selinexor is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, particularly in patients who are not eligible for transplant. The main therapeutic indication for Selinexor is multiple myeloma. It works by inhibiting a protein called XPO1, which is involved in the transport of certain molecules out of the cell nucleus, leading to the accumulation of tumor suppressor proteins in the nucleus and inducing cancer cell death. Selinexor is classified as a selective inhibitor of nuclear export (SINE).

  • Bortezomib

    Bortezomib is administered via injection, either intravenously or subcutaneously. It is an established medication in the treatment of multiple myeloma and is being studied in combination with other drugs like Selinexor. Bortezomib is used to treat multiple myeloma by inhibiting the proteasome, a complex that breaks down proteins in cells, leading to the accumulation of proteins that can cause cancer cell death. It is classified as a proteasome inhibitor.

  • Lenalidomide

    Lenalidomide is taken orally in capsule form. It is widely used in the treatment of multiple myeloma and is being evaluated in combination therapies in clinical trials. Lenalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory agent.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind 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, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and weakness. Over time, the disease can cause significant complications, including kidney dysfunction and bone lesions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512276-35-00Estimated enrolment50 patientsSponsorOdense University Hospital

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