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

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What is this study about?

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.

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 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 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 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 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 Study?

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.

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
Oslo Universitetssykehus HF	Oslo	Norway
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Helse Forde HF	Foerde	Norway
North Estonia Medical Centre Foundation	Tallin	Estonia

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.03.2021
Estonia	Recruiting	01.03.2021
Norway	Recruiting	01.03.2021

Trial locations

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.

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 ID:

2024-512276-35-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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