Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Study of Isatuximab in combination with Bortezomib, Cyclophosphamide and Dexamethasone followed by isatuximab and lenalidomide maintenance in Newly Diagnosed Patients with Multiple Myeloma and severe Renal Impairment

This research study is for adults recently diagnosed with multiple myeloma who also have severe kidney problems. It's looking at a new way to treat their condition using a combination of drugs: isatuximab, bortezomib, cyclophosphamide, and dexamethasone. After an initial treatment period, patients will continue with isatuximab and lenalidomide to help keep the myeloma under control. The main goal is to see how many patients experience an improvement in their kidney function after six months. Researchers will also be checking how well these treatments reduce the myeloma itself, how long people stay well, and if there are any side effects. The study aims to find better treatment options for this specific group of patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hellenic Society Of Hematology, Hellenic Society Of Hematology

Enrolment target

Start

09 Dec 2024

Newly diagnosed patients with multiple myeloma and severe renal impairment

What is this study about?

This study is called a 'Phase 2' trial, which means researchers are actively testing a new treatment plan to see if it's safe and effective. It focuses on a specific group of people: those who have been newly diagnosed with multiple myeloma and also have serious kidney problems. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow, and it can often damage the kidneys.

The main idea behind this study is to combine several established medications for multiple myeloma with a newer drug called isatuximab. The medicines used in the first part of the treatment are isatuximab, bortezomib, cyclophosphamide, and dexamethasone. After this initial phase, patients will then receive isatuximab and lenalidomide as a maintenance treatment, which means ongoing treatment to try and keep the myeloma from coming back or getting worse. The hope is that this combination will be particularly helpful for patients whose kidneys have been affected by the myeloma.

The most important question this study wants to answer is whether this treatment combination can improve kidney function for patients. Researchers will measure how many people show signs of better kidney health after six months of treatment. They will also look at how effective the treatment is at shrinking the myeloma, how long people remain stable without their disease getting worse, and what side effects might occur. Understanding these factors will help doctors decide if this new approach could become a standard treatment for patients with multiple myeloma and kidney issues.

Key takeaways

The study tests a new drug combination for newly diagnosed multiple myeloma.
It's for people who also have severe kidney problems.
The main goal is to see if kidney function improves.
Researchers will also check how well the myeloma is controlled and look for side effects.
Participation involves regular clinic visits and monitoring.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or older. The study is open to both men and women.

Crucially, you must have been recently diagnosed with multiple myeloma. This isn't a study for people who have had myeloma for a while or who have already received extensive treatment for it. A key part of qualifying for this study is also having severe kidney problems due to your myeloma.

Your doctor will check other medical information to make sure this study is right for you and safe, and that you meet all the specific requirements. They will explain if your particular situation fits all the necessary criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been newly diagnosed with multiple myeloma?
Do you have severe kidney problems related to your myeloma?
Are you willing to follow a specific treatment and visit schedule?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a specific combination of medications: isatuximab, bortezomib, cyclophosphamide, and dexamethasone. This will be followed by a maintenance treatment phase using isatuximab and lenalidomide. These medicines will be given according to a set schedule that your study doctor and team will explain in detail.

You will have regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health, how the treatment is working, and to check for any side effects. These assessments will include looking at your kidney function and how your myeloma is responding to the treatment. The study also involves follow-up visits after the main treatment period to continue monitoring your health and the long-term effects of the treatment. The total duration of your participation, including follow-up, could be for up to 36 months from the time the first patient joined the study.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you would receive a new combination of treatments that could be more effective at improving your kidney function and controlling your myeloma than standard treatments. However, there's no guarantee it will work for everyone, and it might not be better than existing options. Potential risks include side effects from the medications, which your care team will monitor closely. You will be given a complete list of possible side effects before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Greece

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects certain white blood cells called plasma cells, which are found in your bone marrow.

What does 'severe renal impairment' mean?

This means your kidneys are not working as well as they should, which is a common problem for people with multiple myeloma.

What is a 'Phase 2' study?

A Phase 2 study is a stage of clinical research where doctors test a new treatment to see if it's safe and helps people, and to figure out the right dose.

Will I know if the treatment is working?

Your doctors will regularly check your kidney function and myeloma levels to see how you are responding to the treatment and will discuss the results with you.

Is this a new medicine?

Isatuximab is a newer medicine being tested in combination with other established medicines for multiple myeloma in this specific group of patients.