RecruitingPHASE3INTERVENTIONAL

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

This research study is looking at a new medicine, AZD0120, for people recently diagnosed with multiple myeloma, a type of blood cancer. It's specifically for those who aren't able to have an autologous stem cell transplant (ASCT), which is a common intensive treatment. The study aims to see if adding AZD0120 to existing treatments (like IsaVRd or DRd) helps control the cancer more effectively and keeps people well for longer, compared to current standard treatments alone. Participants will receive initial treatment, followed by either AZD0120 or continued standard treatment. Researchers will carefully check how well these treatments work and if they cause any side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

750

Start

26 Jun 2026

Estimated completion

12 May 2034

Newly Diagnosed Multiple Myeloma

What is this study about?

This study is for adults who have recently been diagnosed with multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells, which are found in your bone marrow. These cells are important for your immune system, but in multiple myeloma, they become abnormal and can cause problems in your bones and blood. This study is specifically for people who cannot have a stem cell transplant, which is an intensive treatment sometimes used for this condition.

The main goal of this study is to compare a new medicine called AZD0120 with treatments that are already widely used. We want to see if AZD0120, when given after an initial course of treatment, can help people stay well for longer without their cancer getting worse. The study will look at two groups: one group will get a single dose of AZD0120 after their first treatment, and the other group will continue with their standard medication. Both groups will receive treatments that are already known to be effective for multiple myeloma, such as IsaVRd or DRd.

By comparing these two approaches, researchers hope to find out if AZD0120 could be a better option for treating multiple myeloma in people who can't have a stem cell transplant. The study will also carefully check for any side effects and how people tolerate the new medicine. This research is important because it could lead to new ways to help people with this condition live longer and have a better quality of life.

Key takeaways

This study is for adults with recently diagnosed multiple myeloma who cannot have a stem cell transplant.
It compares a new medicine (AZD0120) with current standard treatments.
The goal is to see if AZD0120 helps control the cancer better and keeps people well for longer.
Participation involves initial treatment, then either AZD0120 or continued standard treatment, with regular check-ups.
You will receive close medical monitoring throughout the study.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have a confirmed diagnosis of multiple myeloma that has been recently found. Your cancer must also show certain measurable signs, like specific levels of proteins in your blood or urine.

A key requirement is that you must not be able to have an autologous stem cell transplant (where your own healthy blood stem cells are put back into your body) as your first treatment. However, you would need to be healthy enough for a different type of cell treatment called CAR-T cell treatment, if that were ever considered. You also need to be generally well, able to perform daily activities without too much difficulty, and have your organs (like your liver, kidneys, and bone marrow) working well enough.

There are also reasons why you might not be able to join. For example, if your myeloma has spread to your brain or spinal cord, or if you have certain other serious medical conditions like uncontrolled heart problems, certain infections (like HIV or active hepatitis), or other types of cancer that have not been clear for at least two years. The study team will review all your medical information carefully to see if it's right for you.

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 or older?
Have you recently been diagnosed with multiple myeloma?
Are you unable to have a stem cell transplant as your initial treatment?
Do you have measurable signs of myeloma (e.g., protein levels in blood/urine)?
Are your organs generally working well and are you able to manage daily activities?
Do you have any other serious medical conditions or infections that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have several health checks to make sure the study is suitable for you. Once enrolled, you will be randomly assigned to one of two groups. This is like flipping a coin – neither you nor your doctor can choose which group you are in.

Both groups will receive an initial course of standard multiple myeloma treatments, such as IsaVRd or DRd. After this initial treatment, one group will receive a single dose of the new medicine, AZD0120. The other group will continue with their standard treatments (IsaRd or DRd) for a longer period.

You will have regular visits to the hospital for check-ups, blood tests, and to receive your study medication. These visits will help the doctors monitor how you are responding to the treatment and check for any side effects. The total length of your participation will depend on how you respond to the treatment and the study plan, but it will involve ongoing follow-up for a significant period to track your health and the cancer's status.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving close medical attention and access to a new treatment, AZD0120, which might be more effective than current standard care. However, like all medications, the study treatments, including AZD0120 and the standard drugs, can have side effects. These could range from mild to serious, and the study team will discuss all known and possible risks with you. It's important to remember that not everyone will benefit from participating, and there's a chance the new treatment may not work better than existing ones. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (124)

Research Site
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Gilbert, United States· Not yet recruiting
Research Site
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Phoenix, United States· Not yet recruiting
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Tucson, United States· Not yet recruiting
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Orange, United States· Not yet recruiting
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Santa Monica, United States· Not yet recruiting
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Aurora, United States· Not yet recruiting
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Denver, United States· Not yet recruiting
Research Site
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New Haven, United States· Not yet recruiting
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Coral Gables, United States· Not yet recruiting
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Tampa, United States· Not yet recruiting
Research Site
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Atlanta, United States· Not yet recruiting
Research Site
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Chicago, United States· Not yet recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are important white blood cells found in your bone marrow. These cells help fight infection, but in myeloma, they become abnormal and can cause problems in your bones and blood.

What is a stem cell transplant and why can't I have one?

A stem cell transplant (specifically, an 'autologous' one using your own cells) is an intensive treatment for multiple myeloma. This study is for people who, for various health or medical reasons, are not able to undergo this type of transplant as their initial treatment.

What does 'randomised' mean in a study?

Being 'randomised' means that you are put into one of the study's treatment groups by chance, like flipping a coin. This ensures that the groups are as similar as possible, so researchers can fairly compare the treatments.

Will I know which treatment I am receiving?

Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving (either AZD0120 or continued standard therapy).

What is the purpose of the new drug AZD0120?

AZD0120 is a new medicine being tested to see if it can improve how well multiple myeloma is controlled and help people stay well for longer, especially when added to current standard treatments for those who cannot have a stem cell transplant.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.