Not yet recruitingOBSERVATIONAL

REal World MAIA UK OutcomEs

This study, called REal World MAIA UK OutcomEs, is investigating how a myeloma treatment named DRd (daratumumab, lenalidomide, and dexamethasone) is used in the UK. This treatment is now standard for people who have just been diagnosed with a type of myeloma called multiple myeloma and are not able to have a stem cell transplant. Researchers want to understand how effective DRd is in everyday practice, particularly when doctors adjust the doses of the medications to suit each patient, which isn't always done in official clinical trials. They are gathering information from patient records to see if this flexible approach helps people feel better and if it leads to good outcomes, especially for those who might be frailer or have other health conditions.

At a glance

Status

Not yet recruiting

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Enrolment target

300

Start

01 Jul 2026

Estimated completion

01 Jul 2028

Myeloma

What is this study about?

This study is gathering information about a specific treatment for a type of blood cancer called multiple myeloma. The treatment is a combination of three medicines: daratumumab, lenalidomide, and dexamethasone, often called DRd. This DRd treatment is now a standard option in the UK for people who have just been diagnosed with multiple myeloma and whose doctors have decided they cannot have a stem cell transplant. Before this, we mostly had information from very controlled clinical trials, where patients often fit a very specific profile.

What makes this study important is that it's looking at how DRd is used in 'real life' UK hospitals and clinics. Doctors often adjust the doses of medicines, especially lenalidomide and the steroid dexamethasone, to make sure patients tolerate the treatment well and to reduce side effects. This flexible approach aims to prevent problems like diabetes caused by steroids or infections. However, we don't have much information about how well this dose adjustment works or if it helps patients with other health problems who wouldn't usually be included in a formal clinical trial.

So, this study will collect information from existing patient records to see if this practical way of using DRd is effective and safe. It will also look at patients who might have started with a different treatment but switched to DRd, which is also not something covered in the original clinical trials. By understanding how DRd works in the real world, including with dose adjustments, doctors can better care for all patients with newly diagnosed multiple myeloma.

Key takeaways

This study looks at how a myeloma treatment called DRd is used in routine UK care.
It focuses on patients with newly diagnosed myeloma who can't have a stem cell transplant.
Researchers want to understand how flexible dose adjustments by doctors affect treatment outcomes.
The study uses existing medical records; you don't need to do anything extra.
The goal is to improve care for future patients with multiple myeloma.

Who may be eligible?

To be included in this study, you would need to be an adult (18 years or older) who has been diagnosed with multiple myeloma and, at the time of your diagnosis, your doctors decided you weren't suitable for a stem cell transplant. You must have started your DRd treatment after September 2023, which is when this treatment became widely available in the UK, and have at least three months of follow-up information available from your medical records.

This study will not include people who have taken part in another clinical trial for their first myeloma treatment. Also, if your DRd treatment began for myeloma that had come back or got worse, rather than for a brand new diagnosis, you would not be included. Lastly, if there isn't enough information in your medical records about your treatment or follow-up, your data wouldn't be part of this study.

Quick self-check

Are you 18 years old or over?
Have you been diagnosed with multiple myeloma?
Were you unable to have a stem cell transplant when you were diagnosed?
Did you start DRd treatment after September 2023?
Do you have at least 3 months of follow-up information about your DRd treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This is a 'real-world' study, which means it doesn't involve giving you new medicines or asking you to attend extra hospital visits. Instead, researchers will be looking back at information already collected in your medical records from your routine care. This includes details about your diagnosis, the DRd treatment you received, how your doctors adjusted the doses, and how you responded to the treatment. There are no special requirements for you, and your regular appointments and treatments will continue as normal. You won't need to do anything differently or take any extra steps.

Potential risks and benefits

Since this study only involves looking at existing medical records, there are no direct physical risks to you from taking part. The potential benefit is that the information gathered from your treatment journey will help doctors better understand how DRd works in real life for many patients, especially with common dose adjustments. This knowledge can then help improve care for future patients with multiple myeloma. Participation is entirely voluntary, and if for any reason you or your doctor decide you don't want your anonymised data to be included, you always have the right to withdraw without affecting your care.

Locations (1)

The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom

Common questions

What is multiple myeloma?

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

What is DRd treatment?

DRd is a common treatment for multiple myeloma. It's a combination of three medicines: daratumumab, lenalidomide, and dexamethasone.

What does 'transplant ineligible' mean?

It means that for various reasons, such as age or other health conditions, a stem cell transplant is not considered the best or safest treatment option for a patient.

Will this study affect my current treatment?

No, this study only looks at information from your past medical records. It will not change your current or future treatment plan in any way.

Is my personal information kept private?

Yes, all patient data collected for this study will be handled with strict confidentiality and anonymised, meaning your personal details will not be identifiable.

How to find out more

Tanweer Ahmed

rwh-tr.ukchart@nhs.net 01902 695065 Official trial record

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