RecruitingPHASE2INTERVENTIONAL

Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma

This research trial is for people with an early form of blood cancer called "smouldering myeloma" (SMM). Smouldering myeloma doesn't usually cause symptoms, but some people are at higher risk of it developing into active myeloma over time. We're testing a new combination of three drugs: Isatuximab, Iberdomide, and Dexamethasone. These drugs are being studied to see if they can help stop or delay smouldering myeloma from progressing into active myeloma. We also want to understand if this new treatment combination is safe and acceptable for patients to take. Normally, people with smouldering myeloma don't get treatment, just regular check-ups, so this trial is exploring a new approach for those with higher-risk SMM.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University College, London

Enrolment target

Start

02 Jun 2025

Estimated completion

01 Nov 2032

Smouldering Myeloma

What is this study about?

This study is about a condition called 'smouldering myeloma'. Think of smouldering myeloma as an early, quiet stage of a blood cancer called myeloma. Most people with smouldering myeloma don't have any symptoms and aren't treated right away; instead, doctors watch them carefully with regular check-ups. However, for some, smouldering myeloma can slowly develop into a more active form of the disease called 'multiple myeloma'. When this happens, it usually requires treatment.

This trial is specifically for people whose smouldering myeloma has a higher chance of becoming active multiple myeloma. We are investigating a new treatment approach using a combination of three different medicines: Isatuximab, Iberdomide, and Dexamethasone. The main goal is to see if giving these drugs early can prevent or delay the smouldering myeloma from turning into active multiple myeloma. We also want to find out if this combination of drugs is safe and whether people can tolerate it well.

Currently, there isn't a standard treatment to prevent smouldering myeloma from progressing. This study is important because it could lead to new ways of helping people with higher-risk smouldering myeloma, potentially improving their health outcomes and quality of life by catching the disease before it becomes more serious.

Key takeaways

This study is for early-stage myeloma with a higher risk of progressing.
It tests a new combination of three drugs: Isatuximab, Iberdomide, and Dexamethasone.
The goal is to prevent or delay the disease from becoming active myeloma.
Participation involves regular clinic visits and tests.
You can withdraw from the study at any time.
This is a Phase 2 trial, meaning it's still an early stage of testing new treatments.

Who may be eligible?

To join this study, you need to be at least 18 years old and willing to follow all the study's requirements, including attending appointments and having tests done. You must have been diagnosed with an early form of myeloma called 'smouldering myeloma' within the last five years, and specifically, your smouldering myeloma must be considered 'intermediate' or 'high-risk' within the last two years.

Your smouldering myeloma is considered 'intermediate' or 'high-risk' if you have two or more specific signs. These include a certain percentage of myeloma cells in your bone marrow, a particular level of a protein in your blood, or specific genetic changes in your cells. You also need to have measurable disease, meaning your doctors can track your condition through specific blood or urine tests.

There are also some health requirements related to your general fitness, and how well your liver, kidneys, and bone marrow are working. This is to make sure it's safe for you to take part in the study. Your doctor will carefully check all these details to see if this study is right 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.

Are you at least 18 years old?
Have you been diagnosed with 'smouldering myeloma' that is considered 'intermediate' or 'high-risk'?
Are you able to attend regular appointments and have blood tests?
Is your general health, including your liver, kidneys, and bone marrow, strong enough to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking a combination of three medicines: Isatuximab, Iberdomide, and Dexamethasone. The study will involve regular visits to the hospital or clinic for blood tests, check-ups, and to receive your medication. You'll have blood and urine tests to monitor your health and the progress of your smouldering myeloma. You may also need other tests, like bone marrow biopsies, as required by the study plan.

The overall length of your participation will depend on how you respond to the treatment and the study's plan for follow-up. It's important to understand that your participation will involve a commitment to these regular visits and tests over a period of time, ensuring researchers can collect all the necessary information about the treatment's safety and effectiveness.

Potential risks and benefits

Taking part in this study could offer some benefits, such as receiving a new treatment earlier that might help prevent or delay your smouldering myeloma from getting worse. However, there are also potential risks, as these drugs can have side effects, which your medical team will discuss with you. You might experience common side effects like tiredness, rashes, or changes in blood counts, and some side effects could be more serious, though rare. You will be closely monitored, and your safety is the top priority. Remember, joining any clinical trial is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Barts Health Trust
Verified postcode
London, United Kingdom· Recruiting
Nottingham City Hospital
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is 'smouldering myeloma'?

It's an early, quiet stage of a blood cancer called myeloma that doesn't usually cause symptoms yet.

Why is this study important?

It's testing a new approach to prevent smouldering myeloma from developing into a more serious active form of the disease.

Will I get treatment if I don't join the study?

Patients with smouldering myeloma usually have regular check-ups without treatment, unless their condition progresses.

Are the study drugs new?

Two of the drugs, Isatuximab and Iberdomide, are newer and are being tested in combination with Dexamethasone.

What is 'high-risk' smouldering myeloma?

It means your smouldering myeloma has a higher chance of progressing to active myeloma, based on specific medical signs.

How to find out more

MODIFY Trial Manager

ctc.modify@ucl.ac.uk 02076799860 Official trial record

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