Study of isatuximab, belumosudil and dexamethasone combination treatment for patients with relapsed or refractory multiple myeloma

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What is this study about?

This clinical trial focuses on treating Multiple Myeloma that has returned or stopped responding to previous treatments. The study will test a combination of three medications: isatuximab (given through an intravenous infusion), belumosudil (taken as a film-coated tablet), and dexamethasone (taken as a tablet). Multiple Myeloma is a type of blood cancer that affects plasma cells, which are special white blood cells that help fight infections.

The purpose of this study is to find the right dose of these medications when used together and to see how well they work in treating Multiple Myeloma that has come back or is not responding to other treatments. The study is divided into two parts: first, researchers will determine the best dose of the medications, and then they will test how well this combination works in more patients.

During the study, participants will receive the combination of these medications. The treatment will continue as long as it is helping the patient and any side effects can be managed. Researchers will monitor how the cancer responds to the treatment and track any side effects that may occur. They will also look at how the medications work in the body and assess how the treatment affects patients’ quality of life.

1 Initial treatment cycle

Treatment consists of three medications: isatuximab (given through intravenous infusion), belumosudil (taken as oral tablets), and dexamethasone (taken as oral tablets)

Treatment is provided to patients with relapsed or refractory multiple myeloma who have received at least 2 prior therapies

2 Regular monitoring

Your doctor will monitor the response to treatment through regular blood tests that measure protein levels

Quality of life assessments will be conducted using standardized questionnaires

Side effects will be tracked throughout the treatment period

3 Treatment continuation

Treatment continues as long as it provides benefit and is well-tolerated

Regular evaluations will assess how well the cancer is responding to treatment

Blood samples will be collected to measure medication levels in your body

4 Follow-up period

After completing treatment, you will have follow-up visits to monitor your health status

Your doctor will continue to track your overall survival and disease progression

The study is planned to continue until September 2028

Who Can Join the Study?

Must be 18 years of age or older
Must have an ECOG performance status of 0-1 (meaning able to perform daily activities with minimal or no restrictions)
Must have multiple myeloma that has returned or not responded to at least 2 previous treatments, including:
- Proteasome inhibitors (PIs)
- Immunomodulatory drugs (IMiDs)
Must have measurable disease, shown by at least one of these:
- Blood protein level (M protein) of 0.5 g/dL or higher
- Urine protein level (M protein) of 200 mg or more in 24 hours
- Certain levels of light chain proteins in blood when other proteins are not measurable
Must be willing to use effective birth control methods during the study (applies to both men and women who can have children)
For specific study group (Substudy 05): Must have received at least 2 cycles of:
- Previous anti-CD38 therapy
- BCMA targeted therapy (if available in your region)

Who Cannot Join the Study?

Prior treatment with isatuximab (a type of cancer medication) or any other anti-CD38 antibody therapy
Active brain metastases (cancer that has spread to the brain) or symptoms suggesting brain involvement
History of severe allergic reactions to monoclonal antibodies (a type of targeted therapy)
Significant heart conditions including heart failure, irregular heartbeat, or recent heart attack (within 6 months)
Active or chronic infections, including:
- Hepatitis B
- Hepatitis C
- HIV
Other active cancers requiring treatment (except for certain skin cancers or early-stage cancers that have been successfully treated)
Severe kidney problems requiring dialysis
Severe liver dysfunction
Pregnancy or breastfeeding
Unable to use effective contraception during the study and for 5 months after the last dose
Participation in other clinical trials within 30 days before starting this study
Mental conditions that could interfere with following study procedures
Any medical condition that the study doctor believes would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Evangelismos S.A.	Athens	Greece
Alexandra Hospital	Athens	Greece
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Iaakzdwx Raoyyjbxo Piu Ly Srfkdr Dnd Tgbdby Dxjh Atloqsz Iscb Stdist	Meldola	Italy
Gxjjml Urgxphqyqa Fngakivho	Frankfurt	Germany
Afspnxe Uewpt Sxwlsiiwb Lhbzbv Dk Bxgftml	Bologna	Italy

Trial status

Country	Status	Recruitment Start
France	Recruiting	24.04.2024
Germany	Recruiting	24.04.2024
Greece	Recruiting	24.04.2024
Italy	Recruiting	24.04.2024
Norway	Recruiting	24.04.2024
Portugal	Not recruiting	24.04.2024

Trial locations

Investigated drugs:

Isatuximab is a medication used to treat multiple myeloma, a type of blood cancer. It works by targeting a specific protein on cancer cells, helping the immune system to identify and destroy these cells.

Belumosudil (also known as SAR445761) is a medication that helps regulate the immune system’s response. In this trial, it is being tested in combination with other medications to treat multiple myeloma that has returned or stopped responding to previous treatments.

Dexamethasone is a steroid medication commonly used in cancer treatment. It helps reduce inflammation and can make other cancer treatments more effective. It is often used in combination with other medications to treat multiple myeloma.

Investigated diseases:

Plasma cell myeloma refractory

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. These abnormal cells produce large amounts of a single type of antibody, known as M protein. The disease can cause bone pain, frequent infections, fatigue, kidney problems, and weakening of the bones. Multiple myeloma typically progresses through different stages, with periods of active disease alternating with periods of remission.

Cancer – A disease characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells divide rapidly and can invade nearby tissues, potentially spreading to other parts of the body through the blood and lymph systems. Cancer cells develop due to damage or changes to DNA, which can be caused by various environmental or genetic factors. The disease can affect any part of the body and typically forms solid tumors, except in blood cancers. Cancer cells interfere with normal cell functions and can disrupt organ systems.

Trial ID:

2024-514992-16-00

Protocol code:

ACT16482-05

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of isatuximab, belumosudil and dexamethasone combination treatment for patients with relapsed or refractory multiple myeloma

What is this study about?

Who Can Join the Study?

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