Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PRE-emptive DAratumumab Therapy Of minimal Residual disease reappearance or biochemical relapse in multiple myeloma (PREDATOR).

This study, called PREDATOR, is for people with multiple myeloma. It's looking at whether using a medicine called DARZALEX (daratumumab) early can stop the cancer from fully returning or growing. Specifically, it focuses on patients where very small amounts of cancer cells (minimal residual disease, or MRD) reappear, or if blood tests show early signs of the cancer coming back (biochemical relapse). Researchers want to see if giving DARZALEX at these early stages can help people live longer without their cancer getting worse, compared to just observing them. The study is in an earlier stage (Phase II), meaning it's still exploring how well the treatment works in this specific situation.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Polish Myeloma Consortium

Enrolment target

274

Start

02 Dec 2024

Multiple Myeloma and Minimal Residual Disease

What is this study about?

This clinical trial, called PREDATOR, is for people who have been treated for multiple myeloma, a type of blood cancer. Sometimes, after treatment, the cancer can start to show very early signs of returning. This might be detected by very sensitive tests that find tiny amounts of cancer cells (doctors call this 'minimal residual disease reappearance') or by blood tests that show changes even before symptoms appear (called 'biochemical relapse').

The main idea of this study is to see if starting a specific anti-cancer drug called DARZALEX (daratumumab) at these very early stages can help. The study wants to find out if giving DARZALEX early can keep the cancer from fully coming back or getting worse, compared to a strategy of watching and waiting until the cancer is more clearly active.

Researchers will compare two groups of patients: one group will receive DARZALEX, and the other group will be closely monitored without immediate treatment. They will then look at how long patients in each group live without their disease getting worse. They will also check to see if the treatment helps shrink the cancer or keep it stable, and look for any serious health problems that might develop.

Key takeaways

This study is for people with multiple myeloma whose cancer shows early signs of returning.
It tests if early use of DARZALEX can prevent the cancer from fully coming back.
You would be randomly assigned to receive DARZALEX or be observed.
Participation involves regular hospital visits for assessments.
It aims to see if early treatment helps people live longer without their disease getting worse.

Who may be eligible?

To join this study, you generally need to be an adult, 18 years or older, and can be of any gender. The study is specifically for people who have multiple myeloma.

Crucially, you must have one of two specific situations happening with your myeloma: either your doctor has found very small amounts of cancer cells reappearing in your body after previous treatment (minimal residual disease reappearance), or your blood tests are showing early signs that your myeloma is starting to become active again (biochemical relapse).

There will be other detailed medical checks to make sure the study is safe and right for you, but these are the main conditions for considering participation.

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 diagnosed with multiple myeloma?
Has your doctor told you about minimal residual disease reappearance?
Have your blood tests shown signs of biochemical relapse for your myeloma?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll first go through some checks to make sure it's suitable for you. Once enrolled, you'll be randomly assigned to one of two groups. One group will receive the study drug, DARZALEX, and the other group will be carefully monitored without receiving the drug right away. Random assignment means it's like flipping a coin to decide which group you're in.

If you're in the DARZALEX group, you'll receive the medicine as an injection. Specific details about how often and for how long you'd receive it would be fully explained. Both groups will have regular hospital visits for check-ups, blood tests, and other assessments to monitor your health and how your myeloma is doing. The full duration of your participation, including follow-up visits after treatment, would be clearly outlined by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as receiving a new treatment that isn't widely available yet, or getting very close medical monitoring of your condition. However, there are also potential risks, as DARZALEX, like all medicines, can have side effects. These will be fully explained by the study team and could include reactions to the injection, infections, or other issues. You will be closely monitored for any problems. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Poland

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in the bone marrow.

What does 'minimal residual disease' mean?

It means there are still very small numbers of cancer cells left in the body after treatment, too few to cause symptoms but detectable by sensitive tests.

What is 'biochemical relapse'?

This is when blood or urine tests show early signs that your myeloma is becoming active again, even if you don't feel any symptoms yet.

What is DARZALEX?

DARZALEX (daratumumab) is a medicine used to treat multiple myeloma. It works by targeting specific proteins on the cancer cells.

Will I definitely get the new drug if I join?

No, because this study compares DARZALEX against observation. You will be randomly assigned to one of the two groups, so you might or might not receive the drug.