All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

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

This research is a sub-study focusing on a new treatment approach for multiple myeloma, a type of blood cancer. It combines two existing drugs, belantamab mafodotin and isatuximab, for people whose multiple myeloma has returned or hasn't improved with other treatments. The main goal of this study is to find out how safe these two drugs are when given together and to determine the best dose to use in future, larger studies. It's designed to see if this combination could be a helpful new option for patients who have already tried at least three different types of anti-myeloma treatments, including specific kinds of chemotherapy and antibody therapies.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
GlaxoSmithKline
Enrolment target
30
Start
29 Jul 2021
Estimated completion
11 Mar 2027

What is this study about?

You're probably reading this because you or someone you know is living with multiple myeloma, a type of cancer that affects plasma cells in your bone marrow. When treatments you've tried before haven't worked as hoped, or if the cancer comes back, it can be a really challenging time.

This study, called a 'sub-study', is looking at a new way to treat multiple myeloma that has come back or hasn't responded to previous treatments. It brings together two medicines: belantamab mafodotin and isatuximab. Both of these drugs work in different ways to fight cancer cells, and researchers want to see if combining them might be more effective. The main aim is to understand how safe this combination is and to find the ideal amount, or 'dose', of these medicines to use together.

By taking part, you would be helping doctors and researchers learn more about new ways to treat multiple myeloma. This kind of research is really important for developing new options for patients in the future. It's all about trying to find better and safer treatments for this condition.

Key takeaways

  • This study combines two existing drugs for multiple myeloma: belantamab mafodotin and isatuximab.
  • It's for people whose multiple myeloma has returned or hasn't responded to previous treatments.
  • The main aim is to determine the safest dose of the combination treatment.
  • It's a Phase 1/2 study, meaning it's an early stage of clinical research.
  • Taking part helps researchers find new ways to treat multiple myeloma.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older and have a confirmed diagnosis of multiple myeloma. Importantly, your multiple myeloma should have either come back or not responded to at least three different types of previous treatments. These treatments must have included specific kinds of medications: an ‘immunomodulating agent’, a ‘proteasome inhibitor’, and a ‘CD38 monoclonal antibody’.

There are also some other health requirements. For example, 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, as measured by a score called 'ECOG performance status', also needs to be at a certain level. The doctors will also need to be able to measure your cancer, for example, by checking certain levels in your blood or urine. You would also need to be healthy in other ways, for example, your heart and eyes would need to be checked carefully.

However, some conditions would mean you couldn't join. For instance, if you have certain eye problems (like current corneal disease, except for very mild cases) or significant heart problems, you wouldn't be able to take part. Also, if you've had a bad reaction to similar drugs in the past, or to any of the ingredients in the study medications, you wouldn't be eligible. The study team will review all your medical information carefully to see if this study is 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.

  1. Are you 18 years old or older?
  2. Do you have a confirmed diagnosis of multiple myeloma?
  3. Has your multiple myeloma come back or not responded to at least three previous types of treatment?
  4. Is your general health reasonably good (ECOG score 0-1, or 2 if due to myeloma bone issues)?
  5. Do you have measurable signs of your multiple myeloma (e.g., in blood or urine tests)?
  6. Do you have any current significant eye issues (except mild punctate keratopathy) or heart problems?
Answer every question to see your result.

What does participation involve?

The detailed involvement for this study isn't fully described in the summary, but typically, taking part in a Phase 1 or 2 trial like this involves regular hospital visits. During these visits, you would have blood tests, physical examinations, and possibly scans to monitor your health and how the treatment is working. You would receive the study medications (belantamab mafodotin and isatuximab) according to a specific schedule. The study would keep a close eye on any side effects you might experience. The total duration of your participation would depend on how your body responds to the treatment and the study's design. There would also be a period of follow-up after your treatment finishes to continue monitoring your health.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as gaining access to new treatments that aren't yet widely available. While the specific benefits of this drug combination are still being investigated, some people may find that their cancer responds to the treatment. However, all medications carry potential risks and side effects, and since this is a combination of two drugs, there might be new or increased side effects. Common side effects for these types of drugs can include changes in blood counts, tiredness, nausea, and sometimes skin or eye issues. The research team will carefully explain all known risks. 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 (19)

  • GSK Investigational Site
    Verified postcode
    Atlanta, United States
  • GSK Investigational Site
    Verified postcode
    Boston, United States
  • GSK Investigational Site
    Verified postcode
    Grand Rapids, United States
  • GSK Investigational Site
    Verified postcode
    Madison, United States
  • GSK Investigational Site
    Verified postcode
    Fitzroy, Australia
  • GSK Investigational Site
    Verified postcode
    Salvador, Brazil
  • GSK Investigational Site
    Verified postcode
    São Paulo, Brazil
  • GSK Investigational Site
    Verified postcode
    Toronto, Canada
  • GSK Investigational Site
    Verified postcode
    Villejuif, France
  • GSK Investigational Site
    Verified postcode
    Athens, Greece
  • GSK Investigational Site
    Verified postcode
    Mexico City, Mexico
  • GSK Investigational Site
    Verified postcode
    Oslo, Norway

Common questions

What is multiple myeloma?

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

What does 'RRMM' mean?

RRMM stands for 'Relapsed and Refractory Multiple Myeloma', meaning the cancer has come back after treatment or hasn't responded to previous treatments.

What are belantamab mafodotin and isatuximab?

These are two different medications used to treat multiple myeloma. They work in different ways to target and kill cancer cells.

What is the main goal of this study?

The main goal is to find out how safe these two drugs are when combined and to determine the best dose for future studies.

Will I get 'new' medicine or a placebo?

This study does not mention a placebo; all participants would receive the combination of belantamab mafodotin and isatuximab.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.