Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM

This research study is for people with multiple myeloma, a type of blood cancer, whose treatment hasn't worked or whose cancer has returned. Doctors are studying a new combination of two medications, Belantamab Mafodotin and Nirogacestat. The main purpose is to figure out the safest and most effective dose of these drugs when given together. They also want to understand any side effects and see how well this new combination helps to control the myeloma. This is an early-stage study, meaning it's one of the first times this specific drug combination is being tested in people with this condition.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

106

Start

08 Jun 2020

Estimated completion

11 Mar 2027

Multiple Myeloma

Results

Results from this study

Posted May 2026

Results have been published for this study.

Primary outcome

DE Phase: Number of Participants With Dose Limiting Toxicities (DLTs)

Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, was considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualified as DLTs. Severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Full results on the registry

What is this study about?

This study is mainly about finding the right dose and understanding the safety of a new treatment combination for a type of blood cancer called multiple myeloma. Multiple myeloma happens when certain cells in your bone marrow, called plasma cells, grow too much. This can cause problems with your bones, kidneys, and immune system. Unfortunately, sometimes treatments stop working, or the cancer comes back.

Researchers are testing two active drugs together: Belantamab Mafodotin and Nirogacestat. Belantamab Mafodotin is a type of targeted therapy that helps your immune system fight the cancer cells. Nirogacestat is another drug that works in a different way to stop cancer cells from growing. By combining them, doctors hope to achieve a more powerful effect against the myeloma.

The study has two phases. In the first phase, they will carefully increase the drug doses in small groups of people to find the combination that is both safe and has manageable side effects. Once they find this dose, in the second phase, more people will receive this dose to see how well it works and to learn more about its effects. This is an important step in developing new treatment options for people who have limited choices.

Key takeaways

Tests a new combination of two drugs (Belantamab Mafodotin and Nirogacestat) for multiple myeloma.
Aims to find a safe dose and check how well it works.
For people whose multiple myeloma has returned or not responded to previous treatments.
Involves regular clinic visits and monitoring.
Potential for new treatment, but also possible side effects.

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. Your myeloma must have returned or not responded to at least three different types of previous treatments, including specific kinds of drugs called IMIDs, PI, and an anti-CD38 antibody. If you've had a stem cell transplant, it must have been more than 100 days ago, and you shouldn't have any active infections.

Your general health and physical ability should be reasonably good, meaning you can generally look after yourself, though minor problems due to your myeloma are okay. You must also have clear signs that your myeloma is active and measurable, such as certain levels in your blood or urine tests. If you've had Hepatitis B, you might still be able to join if certain medical conditions are met.

However, some things would prevent you from joining. For example, if you have certain eye conditions (other than very mild ones) or if you have known heart problems. Also, if you've had a severe allergic reaction to similar medications in the past, or to any of the ingredients in the study drugs, you would not be able to participate.

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?
Do you have multiple myeloma that has come back or not responded to at least three prior treatments?
Do you have generally good health, or are any issues mainly due to your myeloma?
Do you have clear signs of active myeloma that can be measured by tests?
Do you have any severe eye conditions or serious heart problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the experimental drug combination, Belantamab Mafodotin and Nirogacestat. The study involves regular visits to the clinic for treatments, check-ups, and tests to monitor your health and the effects of the medication. These tests will include blood tests, urine tests, and possibly other scans or procedures to track your myeloma and watch for any side effects.

The exact schedule and duration of your participation will depend on which phase of the study you are in and how you respond to the treatment. Initially, there will be more frequent visits, and these might become less frequent over time if your condition is stable. After you stop taking the study drugs, you will have follow-up visits to monitor your long-term health. The total duration of participation, including follow-up, can vary by individual but will typically span several months.

Potential risks and benefits

Taking part in a clinical trial offers the possibility of receiving new treatments that aren't widely available yet, which could potentially help your condition. However, there's no guarantee that the treatment will work for you, and there might be side effects. The potential risks of Belantamab Mafodotin can include eye problems (like changes to your vision), and Nirogacestat also has potential side effects which will be fully explained by the study team. You will be closely monitored for any reactions. It's very important to remember that joining this study is entirely your choice, and you have the right to withdraw at any time for any reason, without it affecting your future medical care.

Locations (29)

238995
Verified postcode
Atlanta, United States
240593
Verified postcode
Boston, United States
251164
Verified postcode
Grand Rapids, United States
239015
Verified postcode
Madison, United States
GSK Investigational Site
Verified postcode
Fitzroy, Australia
GSK Investigational Site
Verified postcode
Vancouver, Canada
GSK Investigational Site
Verified postcode
Halifax, Canada
GSK Investigational Site
Verified postcode
Lille, France
GSK Investigational Site
Verified postcode
Villejuif, France
GSK Investigational Site
Verified postcode
Frankfurt, Germany
GSK Investigational Site
Verified postcode
Kiel, Germany
GSK Investigational Site
Verified postcode
Leipzig, Germany

Common questions

What is Multiple Myeloma (MM)?

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

What does 'RRMM' mean?

RRMM stands for Relapsed and Refractory Multiple Myeloma, meaning the cancer has come back after treatment or isn't responding to current treatments.

Are these drugs approved treatments already?

No, this is a clinical trial, so these drugs are being studied together to see if they are safe and effective. Belantamab Mafodotin has been approved as a single agent in the UK for some patients, but the combination with Nirogacestat is still experimental.

Will I get a placebo (dummy drug)?

No, in this study, all participants will receive the active study drugs, Belantamab Mafodotin and Nirogacestat.

What happens if I stop taking part?

You can withdraw from the study at any time for any reason. Your decision will not affect your future medical care.