RecruitingPHASE2INTERVENTIONAL

Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

This research study is about a new medicine called Elranatamab for people diagnosed with 'high-risk smoldering multiple myeloma' (SMM). SMM is a condition that can sometimes turn into a more serious type of blood cancer called multiple myeloma. This study aims to find out if Elranatamab is effective in preventing or delaying this progression in people who haven't had any treatment for SMM yet. We also want to understand if the drug is safe and what side effects it might have. This study is for people aged 18 and over, and all genders can take part. It's a 'Phase 2' study, which means it's one of the earlier steps in testing new medicines.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Stichting European Myeloma Network

Enrolment target

Start

14 May 2024

Estimated completion

01 Jul 2031

Smoldering Multiple Myeloma

What is this study about?

Imagine your body's immune system has special cells called plasma cells that help fight infections. In smoldering multiple myeloma (SMM), these plasma cells start to get a bit faulty and build up in your bone marrow. Even though most people with SMM don't have symptoms, it puts them at a higher risk of developing a more serious condition called multiple myeloma, which is a type of blood cancer.

This study is looking at a new medicine called Elranatamab. We want to see if this medicine can help people with a specific type of SMM, known as 'high-risk smoldering multiple myeloma', which means they are more likely to develop full multiple myeloma. The main goal is to find out if Elranatamab can effectively stop or slow down the progression of SMM in people who haven't received any previous treatment for it.

By taking part in this study, you would be helping doctors understand if Elranatamab could be a new way to treat high-risk SMM. This research is important because it could help prevent people from developing multiple myeloma, ultimately improving their health and quality of life. This is a crucial step in developing new treatments.

Key takeaways

New drug called Elranatamab for high-risk smoldering multiple myeloma.
Aims to see if it works and is safe before the condition gets worse.
For newly diagnosed patients who haven't had previous treatment.
Involves regular clinic visits and health checks.
Participation is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, you need to be 18 years old or older. You must have been diagnosed with smoldering multiple myeloma (SMM) within the last five years, and your doctors need to have identified it as 'high-risk'. This 'high-risk' status is based on certain levels of abnormal proteins in your blood or certain percentages of faulty cells in your bone marrow, meaning you're more likely to develop full multiple myeloma.

Your general health needs to be good, and your blood tests (like those checking your kidney and liver function, and blood counts) must be within healthy ranges. You also cannot have had any previous treatment for multiple myeloma or SMM. Women who are able to have children must agree to use effective birth control throughout the study and for several months afterwards.

There are also reasons why you wouldn't be able to join. For example, if your SMM has already started causing problems like high calcium, kidney issues, serious anaemia, or bone damage, or if you've already had any treatment for multiple myeloma. The research team will carefully check all these points with 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 18 years old or older?
Have you been diagnosed with high-risk smoldering multiple myeloma in the last 5 years?
Have you *not* had any treatment for multiple myeloma or smoldering multiple myeloma?
Do you have good general health, including healthy blood test results?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study drug, Elranatamab. This study is 'open-label', meaning both you and your study doctor will know you're receiving the drug. Over time, you'll have regular visits to the clinic for medical check-ups, blood tests, and other assessments to see how the drug is working and to monitor for any side effects. These assessments will help the doctors understand if the drug is effective and safe for you. The exact number of visits and the full duration of the study will be explained in detail by the study team, but it will involve ongoing follow-up. You'll also be asked to sign a consent form, making sure you fully understand what's involved before you agree to participate.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might have early access to a new treatment, Elranatamab, which could help your 'high-risk smoldering multiple myeloma' and potentially prevent it from getting worse. However, there's no guarantee that the treatment will work for everyone. Potential risks include side effects from the drug, which will be carefully monitored by the study team. You'll be given detailed information about known side effects before you decide to join. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

Helsinki University Hospital
Verified postcode
Helsinki, Finland· Not yet recruiting
CHD Vendée
Verified postcode
La Roche-sur-Yon, France· Recruiting
CHRU de Lille - Hopital Claude Huriez
Verified postcode
Lille, France· Not yet recruiting
CHU Saint Eloi Département d'Hématologie Clinique
Verified postcode
Montpellier, France· Recruiting
CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE
Verified postcode
Nantes, France· Recruiting
CHU NICE - Hôpital Archet
Verified postcode
Nice, France· Recruiting
CHU Poitiers - Pôle régional de Cancérologie
Verified postcode
Poitiers, France· Recruiting
CHRU Hôpital Bretonneau
Verified postcode
Tours, France· Recruiting
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Verified postcode
Athens, Greece· Recruiting
AOU Consorziale Policlinico di Bari
Verified postcode
Bari, Italy· Not yet recruiting
A.O. Papa Giovanni XXIII
Verified postcode
Bergamo, Italy· Recruiting
A.O.U. Careggi
Verified postcode
Florence, Italy· Recruiting

Common questions

What is 'smoldering multiple myeloma'?

It's a condition where faulty immune cells build up in your bone marrow, but it doesn't usually cause symptoms. It can sometimes turn into a more serious blood cancer called multiple myeloma.

What does 'high-risk' mean in this study?

It means your smoldering multiple myeloma has certain features that make it more likely to develop into full multiple myeloma.

What is Elranatamab?

Elranatamab is a new medicine being tested to see if it can help people with high-risk smoldering multiple myeloma.

Will I know if I'm getting the drug?

Yes, this is an 'open-label' study, so both you and your doctor will know you are receiving Elranatamab.

How long will I be in this study?

The study team will explain the full expected length at your first meeting, including how often you'll need to visit and for how long.

How to find out more

Silvia Villa

silvia.villa@emn.org +31 107033123 Official trial record

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