All studies
Not yet recruitingPhase IIIInterventional

Personalising treatment for myeloma patients based on initial response to NHS treatment and their overall fitness level

This study, called iFIT, is for people newly diagnosed with myeloma, a type of blood cancer affecting bone marrow, who are not suitable for a stem cell transplant. These patients are often older or less fit. The study wants to find out if tailoring treatment after the first six months, based on how well initial therapy worked and the patient's fitness, leads to better results than standard NHS care. Participants will receive standard NHS treatment first. Then, their next steps will be decided by their individual response and fitness. The study will test different treatment plans, including newer immunotherapies, to see which works best for different groups of patients. It's hoped this research will help improve future treatment for myeloma.

At a glance

Status
Not yet recruiting
Phase
Phase III
Sponsor
University of Leeds
Enrolment target
1,226
Start
26 Jun 2026
Estimated completion
30 Jun 2030

What is this study about?

The iFIT study is an important research project for people in the UK who have recently been diagnosed with multiple myeloma. Myeloma is a type of cancer that develops from plasma cells in the bone marrow. This study focuses on patients who cannot have a stem cell transplant as part of their initial treatment, which is often the case for older individuals or those who are not as fit. The main goal is to explore whether personalising treatment after the initial phase can lead to better results.

Currently, many patients receive a standard treatment called DRd (daratumumab, lenalidomide, and dexamethasone) from the NHS. In this study, after you've had six months of this standard DRd treatment, the researchers will look at two key things: how well your myeloma has responded to the treatment and your overall fitness level. Based on these factors, you will then follow a specific treatment plan designed to be a better fit for your individual situation. This personalised approach will be compared with other methods to see which works best.

By taking part, you'll be helping doctors understand how to best use existing and new medications for myeloma. Some of the newer treatments offered in this study, which are immunotherapies that help your own body fight the cancer, might not be routinely available on the NHS yet. This study will gather valuable information about these treatments, aiming to discover ways to improve care for people with myeloma both now and in the future.

Key takeaways

  • Targets newly diagnosed myeloma patients unable to have a stem cell transplant.
  • Aims to personalise treatment based on initial response and fitness.
  • May offer early access to newer immunotherapy drugs.
  • Compares different treatment strategies for better outcomes.
  • Requires initial standard NHS treatment for six months.
  • Your participation helps improve future myeloma care.

Who may be eligible?

This study is looking for adults aged 18 or over who have recently been diagnosed with multiple myeloma, or a related condition like plasma cell leukaemia. It's specifically for those whose doctors have decided they cannot have a stem cell transplant as part of their first treatment, and who would usually be recommended the standard NHS treatment called DRd (daratumumab, lenalidomide, and dexamethasone).

To join, you must be willing to give your full consent to take part and follow the study's guidelines, including any pregnancy prevention advice if applicable. You would initially enrol in the study and begin the standard six cycles of DRd treatment. After completing these first six cycles, further assessments will determine your suitability for the next stages of the personalised treatment parts of the study.

There are also specific health criteria based on blood tests and how well your myeloma has responded to your initial treatment. For example, depending on your response and fitness level, you might be recommended different paths within the study. Your doctor will be able to check all the detailed criteria to confirm if this study is right for you.

Quick self-check
  • Are you 18 years old or older?
  • Have you been newly diagnosed with multiple myeloma or a similar condition?
  • Has your doctor said you cannot have a stem cell transplant as your first treatment?
  • Would your doctor usually recommend DRd (daratumumab, lenalidomide, dexamethasone) as your initial treatment?
  • Are you willing to follow any pregnancy prevention advice if applicable?

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

What does participation involve?

If you join the iFIT study, you will first receive the standard NHS treatment of daratumumab, lenalidomide, and dexamethasone (DRd) for six months. During this time, you will have regular hospital visits for your treatment and assessments. After these initial six months, your treatment plan will be adapted based on how your myeloma has responded and your fitness level. This might involve continuing with some of the initial drugs, or receiving newer immunotherapy treatments like teclistamab or talquetamab, depending on your individual situation.

The study involves regular check-ups, assessments, and blood tests to monitor your progress and look for any side effects. The exact number of visits and tests will depend on your specific treatment path within the study. Some of the newer treatments might require you to stay in or near the hospital for monitoring, especially when you first start them. The study is expected to run from June 2026 until May 2037, meaning your participation could last for several years, including follow-up appointments.

Potential risks and benefits

Taking part in the iFIT study offers several potential benefits. It provides an opportunity to receive a personalised treatment approach tailored to your specific response and fitness, which might be more effective than standard care. You could also get earlier access to newer immunotherapy treatments that are not yet widely available on the NHS. Your participation will contribute to valuable research that could significantly improve treatments for future myeloma patients. However, there are potential risks and side effects associated with the study medications. These include a small possibility of developing other types of cancer, which might be slightly increased with lenalidomide. The newer immunotherapy drugs (teclistamab and talquetamab) can cause serious side effects like cytokine release syndrome (flu-like symptoms) and immune effector cell-associated neurotoxicity syndrome (issues affecting the brain). Your medical team will monitor you closely and provide medication to help manage these. You might also be advised not to drive or operate machinery when starting these specific new treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • -
    -, England

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in the bone marrow, affecting important white blood cells called plasma cells.

What does 'transplant-ineligible' mean?

This means that for reasons like age or other health conditions, a stem cell transplant is not considered a suitable treatment option for you.

Will I definitely receive a new immunotherapy drug if I join?

Not necessarily. Your treatment path will be decided after six months, based on your response to initial treatment and your fitness level, which may or may not include a new immunotherapy. The study compares different approaches.

What does 'personalised treatment' mean in this study?

It means your treatment plan after the first six months will be adapted specifically to you, based on how your body reacted to the initial therapy and your overall fitness.

Who is paying for this research?

The study is funded by Cancer Research UK, Blood Cancer UK, and Johnson & Johnson Innovative Medicine, with Johnson & Johnson also providing some of the treatments.

How to find out more

Emma McNaught

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

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