Study on Isatuximab, Bortezomib, and Lenalidomide for Patients with Newly Diagnosed Multiple Myeloma 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 in treating this condition. The treatments being used in the study include Isatuximab, which is a humanized monoclonal antibody that targets a protein called CD38, Lenalidomide, Dexamethasone, and Bortezomib. Isatuximab is also known by its code name, SAR650984. These medications are used together to see if they can help patients achieve a state called minimal residual disease (MRD) negativity, which means that there are no detectable cancer cells left in the body after treatment.

The purpose of the study is to determine how many patients achieve MRD negativity during or after receiving the combination of these treatments. The study will involve several cycles of treatment, starting with two cycles of a combination called IVRd, which includes Isatuximab, Bortezomib, Lenalidomide, and a minimal amount of Dexamethasone. This is followed by six cycles of IVR, which includes Isatuximab, Bortezomib, and Lenalidomide, and then ten cycles of IR, which includes Isatuximab and Lenalidomide. The study is designed to be open-label, meaning that both the researchers and the participants know which treatments are being administered.

Participants in the study will receive these treatments over a period of time, with the maximum treatment period being 18 cycles. The study aims to assess the effectiveness of the treatment combination in achieving MRD negativity and to monitor the overall health and quality of life of the participants. The study will also track any side effects or adverse events that occur during the treatment period. This research is important for understanding how well these treatments work together in patients with newly diagnosed multiple myeloma who are not eligible for a type of transplant called autologous transplant.

1 initial visit and consent

Upon joining the study, the first step involves an initial visit where the study details are explained. A written informed consent is required to confirm understanding and willingness to participate.

During this visit, eligibility is confirmed based on specific criteria, including age, diagnosis of multiple myeloma, and overall health status.

2 screening phase

A series of tests are conducted to ensure eligibility. These tests include blood tests to check bone marrow and kidney function, and a pregnancy test for females of childbearing potential.

The screening phase ensures that all health parameters meet the study requirements before starting the treatment.

3 treatment cycle 1 and 2 (IVRd)

The treatment begins with two cycles of a combination therapy called IVRd, which includes isatuximab administered intravenously, lenalidomide taken orally, dexamethasone taken orally, and bortezomib given as a subcutaneous injection.

Each cycle lasts for a specific period, and the medications are given at prescribed dosages and frequencies as determined by the study protocol.

4 treatment cycle 3 to 8 (IVR)

Following the initial two cycles, the treatment continues with six cycles of IVR, which includes isatuximab, lenalidomide, and bortezomib.

The frequency and dosage of each medication are adjusted according to the study protocol, and regular monitoring is conducted to assess response and manage any side effects.

5 treatment cycle 9 to 18 (IR)

The final phase of treatment consists of ten cycles of IR, involving isatuximab and lenalidomide.

Throughout these cycles, the patient’s health and response to treatment are closely monitored, with adjustments made as necessary to ensure safety and effectiveness.

6 regular monitoring and assessments

During the entire study period, regular visits are scheduled to monitor health status, treatment response, and any side effects.

These assessments include blood tests, physical examinations, and other necessary evaluations to ensure the treatment is working as intended.

7 end of study

Upon completion of the treatment cycles, a final assessment is conducted to evaluate the overall response to the treatment.

The study aims to determine the proportion of patients achieving minimal residual disease negativity, which indicates a significant reduction in cancer cells.

Who Can Join the Study?

Voluntary written informed consent is required.
Participant must be over 18 years of age at the time of signing the informed consent.
Must have newly diagnosed multiple myeloma and not be eligible for high-dose therapy and ASCT (a type of stem cell transplant).
Must have measurable disease as defined by the International Myeloma Working Group, which includes specific levels of M-protein in the blood or urine, or specific levels of immunoglobulin in the blood.
Must have an ECOG performance status score of 0, 1, or 2. A score of 3 is allowed only if it is caused by myeloma. (ECOG performance status is a scale used to assess how a disease affects a patient’s daily living abilities.)
Must have certain clinical laboratory values during the screening phase, including:
- Adequate bone marrow function, such as hemoglobin levels above 7.5 g/dL, absolute neutrophil count above 1.0 x 10⁹/L, and platelet count above 70 x 10⁹/L.
- Adequate kidney function, with an eGFR (a test to measure kidney function) above 30 mL/min/m².
Patient must be willing and able to follow the study protocol visit schedule and other requirements.
Females of childbearing potential must have a confirmed negative pregnancy test within 10-14 days before and again within 24 hours before starting study medication.
Females of childbearing potential and male participants who are sexually active with females of childbearing potential must agree to use highly effective birth control methods during the study and for at least 5 months after the last dose of isatuximab treatment and at least 28 days after the last lenalidomide treatment. Male participants must also refrain from donating sperm during this period.

Who Cannot Join the Study?

Patients who do not have a diagnosis of multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

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

Other Sites

Site Name	City	Country
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.01.2021
Norway	Not recruiting	01.01.2021

Trial locations

Isatuximab is a type of medication known as a monoclonal antibody. It works by targeting a specific protein on the surface of cancer cells, which helps the immune system to recognize and destroy these cells. In this trial, isatuximab is used to help treat multiple myeloma, a type of blood cancer, by reducing the number of cancer cells in the body.

Bortezomib is a medication that helps to treat multiple myeloma by interfering with the growth of cancer cells. It works by blocking a certain protein that cancer cells need to grow and multiply. This helps to slow down or stop the progression of the disease.

Lenalidomide is a medication that helps to treat multiple myeloma by affecting the immune system. It works by enhancing the body’s immune response to fight cancer cells and also by directly attacking the cancer cells to prevent them from growing and spreading.

Dexamethasone is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In the context of this trial, it is used in small amounts to help enhance the effects of the other medications and to manage side effects associated with the treatment of multiple myeloma.

Investigated diseases:

Plasma cell myeloma

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. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to bone damage, anemia, and increased risk of infections. As the disease progresses, it can cause bone pain, fractures, and kidney problems due to the accumulation of abnormal proteins produced by the cancerous cells. Over time, the disease can lead to significant bone loss and damage to other organs. The progression of multiple myeloma is often characterized by periods of remission and relapse. It is a chronic condition that requires ongoing monitoring and management.

Trial ID:

2023-510194-34-00

NCT ID:

NCT04939844

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Isatuximab, Bortezomib, and Lenalidomide for Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?