Active not recruitingPHASE3INTERVENTIONAL

Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

This research study is for people in the UK whose multiple myeloma, a type of blood cancer, has returned. Doctors already know that a combination of drugs called Daratumumab, Lenalidomide, and Dexamethasone (Dara-Len-Dex) can help. What they don't know is the best length of time to give this treatment. Patients will either receive this drug combination for a fixed period of 24 months, or they will continue to receive it until their cancer starts to get worse again. The study aims to find out if taking the drugs for a shorter fixed time is just as good, or perhaps better, than taking them for an unlimited time, especially considering the high cost of these medications. Researchers will compare how long people live after starting treatment in both groups.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

436

Start

25 Jul 2019

Estimated completion

01 Jul 2026

Multiple Myeloma in Relapse

What is this study about?

You're reading this because you, or someone you know, might have multiple myeloma that has returned. This is a type of cancer that affects certain cells in your bone marrow. Even though treatments have improved a lot, it's common for this cancer to return after some time. When it does, doctors look for new ways to manage it.

This study focuses on a specific treatment for multiple myeloma that has come back. The treatment uses a combination of three medicines: Daratumumab, Lenalidomide, and Dexamethasone, often shortened to Dara-Len-Dex. These drugs are already approved and widely used, and they've been shown to be effective. However, what doctors don't yet know is the ideal length of time a person should take this treatment. Should it be taken for a set period, or should it continue until the cancer starts to worsen?

This study wants to compare two approaches: one group of patients will receive the Dara-Len-Dex combination for a set time of 24 months (two years). Another group will receive the same combination for as long as it continues to work and the cancer doesn't get worse. Doctors are doing this to find out if the fixed 24-month treatment is just as good as, or perhaps even better than, continuous treatment for helping people live longer. This is also important because these new drugs are very expensive, so finding the most effective and efficient treatment plan is key. By taking part, you could help doctors understand the best way to use these medications for future patients with multiple myeloma.

Key takeaways

This study is for adults whose multiple myeloma has returned.
It compares two ways of giving a drug combination (Dara-Len-Dex): for a fixed 24 months, or continuously.
The main goal is to see which approach helps people live longer after their cancer has returned.
Your participation could help doctors find the best treatment plan for future patients and manage healthcare costs.
You will receive close medical monitoring throughout the study.
You can stop participating at any time without affecting your standard care.

Who may be eligible?

This study is looking for adults aged 18 or older who have multiple myeloma that has come back, and they need to start a new treatment plan for it. You must have already had one previous treatment for your multiple myeloma, and that treatment must have worked at least reasonably well for you. Your general health and ability to do daily activities should also be at a certain level, as measured by a simple score called ECOG Performance Status (0, 1, or 2).

If you experienced side effects from your previous treatments, like nerve pain, these must have either gone away or be stable before you can join. You'll also need to sign a consent form to show you understand and agree to take part. For women who could become pregnant and men whose partners could become pregnant, effective birth control methods will be required during the study and for 3 months after the last dose of medication. This is because the study drugs can harm a developing baby.

However, you won't be able to join if you've already had a bad reaction or couldn't tolerate lenalidomide or daratumumab (or similar drugs) in the past. This also applies if your multiple myeloma has gotten worse or come back while you were on lenalidomide or daratumumab, or if your condition is resistant to these drugs. If you have any other significant health problems that the study doctors believe could make it unsafe for you to participate, you would also not be eligible.

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?
Has your multiple myeloma come back and do you need new treatment?
Have you had one previous treatment for your multiple myeloma that worked?
Are any side effects from your previous treatment gone or stable?
Are you able to use effective birth control if applicable?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. You'll either receive the Dara-Len-Dex drug combination for a fixed period of 24 months, or you'll receive it continuously until your cancer starts to get worse. You will be seeing the study team regularly for check-ups, blood tests, and to make sure the medication is working and to monitor any side effects. The exact number of visits will be explained by the study team, but they will be more frequent at the beginning and then become less frequent over time. After you stop taking the study medication, the researchers will continue to follow your health and progress for a longer period to see how you're doing. The total time you'll be involved in the study could extend for several years, even after you finish taking the medication itself.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving a standard, effective treatment for multiple myeloma that has returned, potentially helping to control your cancer. You would also receive close medical monitoring. All medications have potential side effects, and Daratumumab, Lenalidomide, and Dexamethasone can cause various side effects, which the study team will discuss in detail with you. You might also experience side effects because of the specific length of treatment you receive. There's no guarantee the treatment will work for you, and sometimes treatments don't work as expected. Your health and comfort are very important, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Saint Antoine Hospital - Hematology Department
Verified postcode
Paris, France

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects the plasma cells in your bone marrow, which are part of your immune system. These cells grow abnormally and can cause problems in your bones, kidneys, and blood.

What are Daratumumab, Lenalidomide, and Dexamethasone?

These are three different medicines used together to treat multiple myeloma. Daratumumab targets cancer cells, Lenalidomide helps your immune system and directly affects cancer cells, and Dexamethasone is a steroid that also fights cancer and helps with side effects.

Why don't doctors know the best treatment length?

While these drugs are effective, it's not yet clear if taking them for a shorter, set period (like two years) is as good as, or better than, taking them continuously until the cancer worsens. This study aims to find the optimal duration.

Will I know which treatment group I'm in?

Yes, this is an "open-label" study, meaning both you and your doctor will know whether you are receiving treatment for 24 months or continuously.

What does 'non-inferiority' mean in this study?

It means the study is trying to show that the 24-month fixed treatment is not significantly worse than, and hopefully just as good as, continuous treatment in terms of how long people live.