Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM

This research study is looking into a new way to treat multiple myeloma, a cancer that affects certain blood cells. It's particularly for people whose myeloma has come back or hasn't responded to previous treatments. The main goal is to check the safety of a combination of four medicines: Belantamab mafodotin, Nirogacestat, Lenalidomide, and Dexamethasone. Once they understand the safety, they will try to find the best dose to use for future studies. This is a "Phase 1/2" study, meaning it's an early stage of testing new treatments, focusing on safety and finding the right dosage before looking at how well it works more broadly. It's part of a larger ongoing research program into multiple myeloma treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

Start

19 Jul 2022

Estimated completion

11 Mar 2027

Multiple Myeloma

What is this study about?

This study is about finding new and better ways to treat multiple myeloma. This is a type of cancer that starts in plasma cells, a kind of white blood cell made in the bone marrow. For some people, treatments don't always work as well as hoped, or the cancer might come back. This is called 'relapsed and refractory multiple myeloma' or RRMM.

The researchers are testing a new combination of four medicines: Belantamab mafodotin, Nirogacestat, Lenalidomide, and Dexamethasone. You might have heard of Lenalidomide (often called Revlimid) and Dexamethasone, which are common myeloma treatments. Belantamab mafodotin and Nirogacestat are newer medicines. By combining these, the hope is to find a treatment that is more effective for people with RRMM. This study is an important step in seeing if this new combination is safe and if it can help patients.

Because this is a Phase 1 and 2 study, the first part (Phase 1) will mainly focus on safety and finding the right dose of these medicines to use together. Once that's established, the study will move into Phase 2, where more people will receive the chosen dose to see how well it works and to continue monitoring for any side effects. This careful approach helps doctors understand new treatments thoroughly before they can be widely used.

Key takeaways

This study is for people with multiple myeloma that has come back or not responded to previous treatments.
It's testing a new combination of four medicines, focusing on safety and finding the right dose.
This is an early-stage clinical trial (Phase 1/2) that helps gather important information about new treatments.
Getting involved means regular clinic visits for checks, blood tests, and receiving the study medicines.
You'll get close monitoring, but there are potential risks and side effects to consider.
You can stop taking part in the study whenever you wish, without affecting your care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of multiple myeloma. Importantly, your myeloma must have returned or not responded to at least three different types of previous treatments, including an immunomodulating drug, a proteasome inhibitor, and a specific anti-CD38 antibody treatment.

Even if you've had a stem cell transplant in the past, you might still be able to join, as long as it was more than 100 days ago and you don't have any active infections. Doctors will also check your general health, including how well your organs are working and your energy levels. There are also specific measurements of your myeloma that need to meet certain levels to confirm it's still active enough for the study.

However, you wouldn't be able to join if you have certain eye conditions (other than very mild ones), serious heart problems, or if you've had a bad reaction to similar medicines in the past. Your doctors will review all your health information carefully to make sure the study safe 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 18 years old or older?
Have you been diagnosed with multiple myeloma?
Has your myeloma returned or not responded after at least three different types of treatment?
Is your general health, including your organ function, considered good enough by the doctors?
Do you have certain levels of myeloma signs in your blood or urine?
Do you have any serious eye problems (more than very mild ones) or major heart issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic. These visits will involve various checks, such as blood tests, urine tests, and other assessments to monitor your health and how the treatment is affecting your body and the myeloma. You will receive a combination of the study medications, which will be given as per the study plan, likely involving both intravenous (through a drip) and oral (by mouth) treatments.

The study visits and assessments are carefully planned to make sure you are safe and that the researchers can gather all the necessary information about the new treatment. After your main treatment period, there will be follow-up appointments to track your long-term health and the lasting effects of the treatment. The total length of your participation will depend on the study's design and your individual response to the treatment, but it will involve a commitment to regular monitoring for a period.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments that aren't yet widely available, which could potentially help your multiple myeloma. However, there are also risks. The medicines in this study, both individually and in combination, can cause side effects. Some common side effects of myeloma treatments include feeling tired, nausea, or changes in blood counts, and there could be other, less common, or more serious side effects specific to these newer drugs. Your study doctor will explain all known risks to you in detail. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

GSK Investigational Site
Verified postcode
Boston, United States
GSK Investigational Site
Verified postcode
Salvador, Brazil
GSK Investigational Site
Verified postcode
São Paulo, Brazil
GSK Investigational Site
Verified postcode
Halifax, Canada
GSK Investigational Site
Verified postcode
Villejuif, France
GSK Investigational Site
Verified postcode
Hamburg, Germany
GSK Investigational Site
Verified postcode
Athens, Greece
GSK Investigational Site
Verified postcode
Mexico City, Mexico
GSK Investigational Site
Verified postcode
Seoul, South Korea
GSK Investigational Site
Verified postcode
Seoul, South Korea
GSK Investigational Site
Verified postcode
Seoul, South Korea
GSK Investigational Site
Verified postcode
Ulsan, South Korea

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow.

What does 'relapsed and refractory' mean?

It means the myeloma has either returned after previous treatment or hasn't responded well to earlier treatments.

Are the medicines in this study new?

Some of the medicines, like Belantamab mafodotin and Nirogacestat, are newer, while others like Lenalidomide and Dexamethasone are more established treatments for myeloma.

What is the main goal of this study?

The main goal is to check how safe this combination of medicines is and to find the best dose to use for people with multiple myeloma that has come back or not responded to other treatments.

Can I stop participating in the study if I want to?

Yes, you can leave the study at any time, for any reason, without it affecting the healthcare you receive.