Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) with VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

This research is a Phase 3 study, which means it’s testing a new treatment combination in a large group of people to see if it’s better than current options. It's for adults with multiple myeloma, a cancer that affects plasma cells in the bone marrow. The study is specifically for those who won't be having a stem cell transplant as their first treatment. The main goal is to compare two different drug combinations: a new one called D-VRd (Daratumumab, VELCADE, Lenalidomide, and Dexamethasone), and the standard VRd (VELCADE, Lenalidomide, and Dexamethasone). Researchers want to see if the new combination can lead to more people having no signs of cancer cells in their bone marrow, known as 'MRD negativity'.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Janssen - Cilag International

Enrolment target

157

Start

17 Nov 2023

Multiple Myeloma

What is this study about?

This study is looking at a type of cancer called multiple myeloma. This cancer affects certain white blood cells in your bone marrow, called plasma cells. These cells help fight infections, but in multiple myeloma, they grow too much and can cause problems in your bones, kidneys, and immune system.

Researchers are testing a new combination of treatments to see if it works better than the standard treatment for people with newly diagnosed multiple myeloma. This study is specifically for those who are not planning to have a stem cell transplant as their first treatment. They want to find out if adding an extra drug, Daratumumab, to the standard VRd treatment (VELCADE, Lenalidomide, and Dexamethasone) can lead to better results.

The main thing the doctors are measuring is called "MRD negativity." This means checking if doctors can find very low levels of myeloma cells in the bone marrow after treatment. If there are no detectable cancer cells, it's a good sign that the treatment has been successful. They want to see if the new four-drug combination helps more people achieve this important goal compared to the standard three-drug treatment.

Key takeaways

This study is for adults with newly diagnosed multiple myeloma.
It's for people who are not having a stem cell transplant as their initial treatment.
It compares a new four-drug treatment with a standard three-drug treatment.
The main goal is to see if the new treatment helps more people achieve 'MRD negativity' (no detectable cancer cells).
Both men and women aged 18 and over can participate.
It's a Phase 3 study, aiming to find better standard treatments.

Who may be eligible?

This study is looking for adults who have been diagnosed with multiple myeloma and have not yet started treatment for it. Participants must be at least 18 years old; there is no upper age limit.

A key part of who can join is that you must not be planning to have a stem cell transplant as your very first treatment for multiple myeloma. This study is specifically looking at other treatment options for people in this situation.

Both men and women can take part in this research. Before joining, the study team will carry out some checks to make sure the study treatment is safe and 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.

I am at least 18 years old.
I have been diagnosed with multiple myeloma.
I have not yet started treatment for my multiple myeloma.
I am not planning to have a stem cell transplant as my first treatment.
I am willing to have regular medical checks and follow study procedures.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of two treatment combinations. These treatments involve taking different medications, some of which are given as injections and others as capsules or tablets.

The study involves regular visits to the hospital or clinic. During these visits, you will have various tests, such as blood tests, examinations, and bone marrow samples taken. These tests help doctors monitor your health, how effectively the treatment is working, and if you are experiencing any side effects.

The overall length of time you will be involved in the study will depend on your individual response to the treatment, but it will involve an initial treatment period and then a follow-up period to continue monitoring your health and the effects of the treatment.

Potential risks and benefits

Participating in this study might offer you access to a new treatment combination that could be more effective than current standard options for multiple myeloma. However, like all medications, the drugs used in this study can have side effects, which could range from mild to serious. The study team will explain these potential risks to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

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

—
Unverified
Spain
—
Unverified
Netherlands
—
Unverified
France
—
Unverified
Germany
—
Unverified
Czechia
—
Unverified
Poland

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects specific white blood cells (plasma cells) in your bone marrow, which is the spongy material inside some of your bones.

What does a 'Phase 3' study mean?

A Phase 3 study is a large research trial that compares a new treatment with an existing one to see if the new treatment is better or has fewer side effects. It's often the last step before a new treatment is considered for widespread use.

What is 'MRD negativity'?

MRD negativity (Minimal Residual Disease negativity) means that after treatment, doctors can't find any remaining cancer cells in your bone marrow, even with very sensitive tests. It's a goal of treatment, as it often suggests a better outlook.

Why is this study only for people not having a stem cell transplant?

This study is specifically looking for effective treatment options for people with multiple myeloma who are not suitable for or choose not to have a stem cell transplant as their first treatment.

Will I know which treatment I am receiving?

In studies like this, participants are usually randomly assigned to one of the treatment groups, and sometimes neither you nor your doctor will know which specific treatment you are receiving. This is called a 'blinded' study, and it helps ensure the results are fair and unbiased.