Not yet recruitingPHASE3INTERVENTIONAL

Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level

The iFIT study is for people recently diagnosed with myeloma, a type of bone marrow cancer, who are not suitable for a stem cell transplant. These patients are often older or have other health conditions. The study starts with the standard NHS treatment, a combination of three medicines: Daratumumab, Lenalidomide, and Dexamethasone (DRd). After six months, doctors will look at how well the treatment has worked and your overall fitness. This information then helps guide which further treatments you receive as part of the study. The main goal is to see if matching treatments to both your initial response and fitness level can lead to better outcomes for patients with myeloma.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

University of Leeds

Enrolment target

1,226

Start

01 Jun 2026

Estimated completion

01 May 2037

Multiple Myeloma (MM)Plasma Cell Leukemia (PCL)

What is this study about?

This study, called iFIT, is looking for a better way to treat myeloma, a type of cancer that affects the bone marrow. It's specifically designed for people who have been diagnosed with myeloma recently and who, because of their age or other health concerns, aren't able to have a stem cell transplant. These patients are usually older and might not be as fit as others.

The idea behind iFIT is to tailor treatment more closely to each person. Everyone in the study will start with a standard NHS treatment that combines three medicines: Daratumumab, Lenalidomide, and Dexamethasone (often called DRd). After about six months on this initial treatment, the study will check two key things: how well the treatment has worked for you and your general fitness level. This information will then help decide what your next treatment steps will be within the study.

By carefully matching continuous treatments to how you responded and your fitness, the iFIT study hopes to find out if this personalised approach can lead to better health and longer lives for people with myeloma. It's about finding the best path forward for different groups of patients, rather than a one-size-fits-all approach.

Key takeaways

This study aims to personalise myeloma treatment.
It's for newly diagnosed patients not suitable for a stem cell transplant.
Initial treatment is a standard NHS combination (DRd).
Further treatments are decided based on your initial response and fitness.
The goal is to improve outcomes by tailoring care.
It could involve newer medications like Teclistamab or Talquetamab.

Who may be eligible?

The iFIT study is looking for adults who have recently been diagnosed with a type of bone marrow cancer called myeloma. You might be suitable if your doctor believes a stem cell transplant isn't the right first treatment for you and usually recommends Daratumumab, Lenalidomide, and Dexamethasone (DRd) as your starting treatment on the NHS. You must be at least 18 years old and be able to understand and agree to take part, as well as follow any guidelines about preventing pregnancy if that applies to you.

However, you wouldn't be able to join if you have a milder type of myeloma (called smouldering myeloma) or related conditions like amyloidosis. If you've already had treatment for myeloma (unless specifically allowed by the study rules), currently have a serious infection needing antibiotics or other medicines, or are pregnant, breastfeeding, or planning a pregnancy, you also wouldn't be able to take part. Also, if you're already in another study for myeloma that involves new medicines, this study might not be suitable 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.

Have I recently been diagnosed with symptomatic myeloma?
Has my doctor said I'm not suitable for a stem cell transplant?
Is my doctor planning to give me Daratumumab, Lenalidomide, and Dexamethasone as my first treatment?
Am I over 18 years old?
Am I willing and able to follow any necessary pregnancy prevention plans?
Do I currently have any serious infections that need ongoing treatment?

Answer every question to see your result.

What does participation involve?

If you join the iFIT study, you'll first receive the standard NHS treatment of Daratumumab, Lenalidomide, and Dexamethasone for six cycles (about six months). During this time, you'll have regular visits for check-ups and assessments to see how you're responding to the treatment. After these six cycles, doctors will review your progress and your fitness. Based on this, you'll be assigned to a specific treatment pathway within the study, which might involve continuing with some or all of the initial medications, or potentially trying newly approved medications named Teclistamab or Talquetamab. You'll continue to have regular follow-up visits and assessments throughout this next phase to monitor your health and how the treatment is working. The total duration of your participation, including follow-up, will be determined by your specific treatment pathway and how you respond.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving treatment tailored to your specific response and fitness level, which could lead to better outcomes than a standard approach. You will also be closely monitored by a healthcare team. However, as with any medical treatment, there are potential risks, including side effects from the medications. Your medical team will discuss these in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Bristol Haematology and Oncology Centre
Verified postcode
Bristol, United Kingdom
Eastbourne District General Hospital
Verified postcode
Eastbourne, United Kingdom
St James University Hospital
Verified postcode
Leeds, United Kingdom
The Royal Marsden Hospital
Verified postcode
London, United Kingdom

Common questions

What is myeloma?

Myeloma is a type of cancer that develops from plasma cells in the bone marrow, which is the spongy tissue inside some of your bones.

What does 'transplant-ineligible' mean?

It means that a stem cell transplant, which is sometimes used for myeloma, is not recommended for you, often due to age or other health conditions.

What are Daratumumab, Lenalidomide, and Dexamethasone (DRd)?

These are medicines commonly used together as a standard NHS treatment for myeloma.

Will I get new medicines like Teclistamab or Talquetamab?

After your initial treatment, some people in the study might receive these newer medications, depending on their response and fitness level, as part of the personalised approach.

How long will the study last for me?

The duration of your participation will depend on your specific treatment plan within the study and how you respond to the medications.

How to find out more

Emma McNaught

ctru-ifit@leeds.ac.uk 0113 343 1978 Official trial record

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