Active not recruitingPHASE3INTERVENTIONAL

Elotuzumab in Combination With Carfilzomib, Lenalidomide and Dexamethasone (E-KRd) Versus KRd in MM

This study is for people who have recently been diagnosed with a type of blood cancer called multiple myeloma. It compares a new treatment combination, E-KRd, with a standard treatment called KRd. The 'E' stands for Elotuzumab, a new type of drug that works with your immune system. Researchers want to see if adding Elotuzumab to the standard KRd treatment can lead to better results, like controlling the cancer more effectively and for a longer time, and if it could help more people achieve deeper responses to treatment. They are also looking at how safe this new combination is for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Wuerzburg University Hospital

Enrolment target

576

Start

28 Aug 2018

Estimated completion

01 Aug 2029

Newly Diagnosed Multiple Myeloma

What is this study about?

Multiple myeloma is a type of cancer that starts in a specific kind of white blood cell called a plasma cell. These cells are found in your bone marrow, the spongy material inside your bones. When you have multiple myeloma, these plasma cells grow out of control and can cause problems like bone damage, kidney issues, and low blood counts.

Over the past few decades, treatments for multiple myeloma have improved a lot. This study is testing if a new combination of medicines, called E-KRd, can be even more effective for people who have just been diagnosed. E-KRd includes drugs you might already know about, like Carfilzomib, Lenalidomide, and Dexamethasone (which together are called KRd), plus a newer drug called Elotuzumab. Elotuzumab is a 'monoclonal antibody,' meaning it's a specially made protein that can find and attack specific cancer cells.

The main goal of this study is to see if adding Elotuzumab to the standard KRd treatment helps control the cancer better and keeps it from coming back for a longer time. Researchers are especially interested to see if this new combination works well for everyone, even for patients whose cancer has certain features that usually make it harder to treat. They also want to understand if the combination causes any new side effects or makes existing ones worse.

Key takeaways

This study compares a new drug combination, E-KRd, with a standard one, KRd.
It's for people newly diagnosed with multiple myeloma.
The goal is to see if E-KRd controls the cancer better and for longer.
Elotuzumab, the 'E' in E-KRd, is a targeted immune therapy.
You must be eligible for a stem cell transplant to join.
Your doctor will discuss all potential risks and benefits in detail.

Who may be eligible?

This study is looking for adults between 18 and 70 years old who have recently been diagnosed with multiple myeloma and haven't started any treatment for it, apart from a small amount of a steroid called dexamethasone, or some procedures like blood filtering or local radiation for bone pain. You must also be generally well enough to have a stem cell transplant, which is a common part of myeloma treatment.

To join, your myeloma needs to meet specific criteria, which a doctor will check. This includes things like having enough abnormal plasma cells in your bone marrow or having signs like bone damage, kidney problems, or anaemia due to the myeloma. Your blood tests will also need to show certain levels of proteins related to your myeloma.

Your doctor will carefully review all your health information and test results to see if this study is a good fit for you. It's important that you don't have any other serious health conditions that might make taking part risky.

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.

I am between 18 and 70 years old.
I have recently been diagnosed with multiple myeloma and haven't started treatment yet (except for some specific exceptions).
My doctor says I would be suitable for a stem cell transplant.
My myeloma meets certain specific criteria that the study doctors will check.
I generally feel well enough to take part in a study and have regular hospital visits.

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of two treatment combinations: either the standard KRd or the new E-KRd. The specific drugs, how often you take them, and how long you take them will be decided by the study doctors. You will have regular appointments at the hospital or clinic for treatments, blood tests, and other checks to see how you are responding and if you have any side effects. This might include bone marrow tests and scans.

Some participants in the study might also have a stem cell transplant as part of their treatment, which is a common procedure for multiple myeloma. After your main treatment phase, you will have regular follow-up appointments, which may involve clinic visits, blood tests, and phone calls. The total time you'll be involved in the study, including follow-up, could be several years.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new treatment combination that could be more effective than standard care for your multiple myeloma. However, there's no guarantee that it will work for everyone, and it might not be better than existing treatments. Like all medications, the drugs used in this study (Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone) can have side effects, which your medical team will discuss with you. These can range from mild to serious. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (56)

Univ. Klinikum Krems
Verified postcode
Krems, Austria
Universitätklinikum St. Pölten
Verified postcode
Sankt Pölten, Austria
LKH-Universitätsklinikum Graz
Verified postcode
Graz, Austria
Medizinische Universität Innsbruck
Verified postcode
Innsbruck, Austria
Kepler Universitätsklinikum
Verified postcode
Linz, Austria
Klinikum Wels-Grieskirchen
Verified postcode
Wels, Austria
LKH Rankweil-Feldkirch
Verified postcode
Rankweil, Austria
Landeskrankenhaus Salzburg
Verified postcode
Salzburg, Austria
AKH Meduni Wien
Verified postcode
Vienna, Austria
Klinik Ottakring
Verified postcode
Vienna, Austria
Universitätsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany
Kliniken Ostalb
Verified postcode
Mutlangen, Germany

Common questions

What is multiple myeloma?

Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. These cells grow abnormally, which can cause problems in your bones, kidneys, and blood.

What are E-KRd and KRd?

KRd is a standard combination of drugs (Carfilzomib, Lenalidomide, Dexamethasone) used for multiple myeloma. E-KRd adds a newer drug called Elotuzumab to this combination, and it's being studied to see if it works even better.

What is Elotuzumab?

Elotuzumab is a type of targeted drug called a 'monoclonal antibody.' It works by helping your immune system find and attack myeloma cells.

Will I get a stem cell transplant if I join?

Many people with multiple myeloma have a stem cell transplant as part of their treatment, and this study is designed for people who are suitable for one. Your doctor will discuss if a transplant is right for you in the context of the study.

What does 'Phase 3' mean for a trial?

A Phase 3 trial means the new treatment has already shown promise in earlier studies and is now being compared to standard treatments in a larger group of people to confirm its benefits and safety before it can be more widely used.