Active not recruitingPHASE3INTERVENTIONAL

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

This study is for people in the UK with multiple myeloma that has returned or not responded to previous treatments. It's comparing a new drug combination, Iberdomide, Daratumumab, and Dexamethasone (called IberDd), against a standard combination, Daratumumab, Bortezomib, and Dexamethasone (called DVd). The main goal is to find out which treatment works best at controlling the myeloma and if the new combination is safe. Participants will be randomly assigned to receive one of these treatment combinations, and doctors will carefully monitor their health and the progress of their condition throughout the study.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Celgene

Enrolment target

939

Start

23 Jun 2022

Estimated completion

25 Jun 2032

Multiple Myeloma

What is this study about?

This study is looking at new ways to treat multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. Sometimes, after initial treatments, the myeloma can come back or not respond fully. When this happens, doctors call it 'relapsed or refractory multiple myeloma'. This study is important because it's testing a new combination of medicines that might be more effective for these patients.

The study compares two treatment approaches. One is a standard combination called DVd, which includes Daratumumab, Bortezomib, and Dexamethasone. The other is a newer combination called IberDd, which uses Iberdomide, Daratumumab, and Dexamethasone. By comparing these two, researchers hope to see if IberDd can offer a better option for controlling the disease and improving patients' health.

Taking part in a study like this helps doctors learn more about the best ways to treat multiple myeloma. The information gathered can lead to new and better treatments for everyone living with this condition in the future. All treatments are given under careful medical supervision and according to strict guidelines.

Key takeaways

Compares two drug combinations for multiple myeloma.
For myeloma that has returned or not responded to previous treatments.
Will randomly assign participants to one of two treatment groups.
Aims to find out which treatment is more effective and safer.
Treatment continues as long as it's working and safe.
Helps advance understanding of multiple myeloma treatments.

Who may be eligible?

To be considered for this study, you must have multiple myeloma that has been officially diagnosed and your doctors must be able to measure your disease activity. You should also have already received one or two different types of treatment for your myeloma in the past, and your myeloma must have gotten worse either during or after your last treatment.

There are also some reasons why you might not be able to join. For example, if you have other specific blood conditions like plasma cell leukaemia or Waldenstrom's macroglobulinemia, or if your myeloma has spread to your brain or spinal cord. If you've already had treatment with the drug Iberdomide, you won't be able to participate either.

Your doctor will check if you can manage daily activities reasonably well and will look at all your medical history to make sure taking part in this study is suitable and safe 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.

Do I have a confirmed diagnosis of multiple myeloma?
Has my multiple myeloma returned or not responded to past treatments?
Have I had only 1 or 2 past treatments for my myeloma?
Am I generally able to manage daily activities without too much difficulty?
Have I never taken the drug Iberdomide before?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two treatment groups – like flipping a coin. You won't know which specific dose of Iberdomide you might receive if you're in that group, and neither will your doctor. You'll receive your assigned treatment combination, which includes Dexamethasone, Daratumumab, and either Iberdomide or Bortezomib.

You will continue to receive treatment for as long as your myeloma is not getting worse and you are not experiencing severe side effects. Throughout the study, you'll have regular hospital visits for blood tests, check-ups, and to receive your medication. Doctors and nurses will closely monitor your health and how your myeloma is responding. Even if you stop your study medicine early for any reason, except if your disease progresses or you decide to withdraw, doctors will continue to check on your myeloma to get a full picture of the treatment's effects. The study aims to follow participants for a long time to understand the full impact of the treatments.

Potential risks and benefits

Like all medical treatments, there's a chance of both benefits and risks. The potential benefit is that one of the new treatment combinations might work better for your multiple myeloma than other available options. However, there's also a risk of side effects, which your medical team will discuss with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care. Your doctors will ensure you understand all aspects before you decide to participate.

Locations (259)

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

Local Institution - 035
Verified postcode
Hot Springs, United States
Local Institution - 641
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Cerritos, United States
Local Institution - 681
Verified postcode
Fountain Valley, United States
Local Institution - 047
Verified postcode
Los Angeles, United States
Local Institution - 684
Verified postcode
Newport, United States
Local Institution - 033
Verified postcode
New Haven, United States
Local Institution - 029
Verified postcode
Fort Myers, United States
Local Institution - 693
Verified postcode
Ocala, United States
Local Institution - 028
Verified postcode
St. Petersburg, United States
Local Institution - 045
Verified postcode
Tamarac, United States
Local Institution - 034
Verified postcode
West Palm Beach, United States
Local Institution - 685
Verified postcode
Weston, United States

Common questions

What is 'relapsed or refractory multiple myeloma'?

This means your multiple myeloma has either come back after treatment or hasn't responded well to previous treatments.

What does 'randomised' mean in this study?

It means you'll be assigned to one of the treatment groups by chance, like drawing a name out of a hat. Neither you nor your doctor will choose which group you're in.

Are the doctors aware of which treatment I am receiving?

Yes, in this kind of study, both you and your doctors will know which treatment combination you are receiving, which is called 'open-label'.

How long will I be on the study treatment?

You'll continue treatment for as long as it's helping control your myeloma and you're not having serious side effects, or unless you decide to stop.

What happens if I stop the treatment early?

Unless your disease gets worse or you choose to withdraw completely, the doctors will still monitor your myeloma to understand the full effects of the treatment.