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Active not recruitingPHASE3INTERVENTIONAL

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

This study is for people in the UK living with multiple myeloma, a type of blood cancer, whose disease has returned or hasn't responded well to earlier treatments. We are looking at two different treatment combinations. One group will receive belantamab mafodotin along with pomalidomide and dexamethasone. The other group will get a standard treatment consisting of bortezomib, pomalidomide, and dexamethasone. The main goal is to find out if the belantamab mafodotin combination is more effective at treating the cancer and if it has fewer or different side effects compared to the standard approach. This type of research helps doctors find better ways to help patients live longer and with a better quality of life.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
GlaxoSmithKline
Enrolment target
302
Start
01 Oct 2020
Estimated completion
25 Oct 2029

What is this study about?

This study is looking into new ways to treat multiple myeloma for people in the UK whose cancer has come back or hasn't improved with their current treatment. Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in the bone marrow. When these cells become cancerous, they can cause problems throughout the body.

In this study, we are comparing two different treatment plans. Both plans include standard medications like pomalidomide and dexamethasone. However, one plan adds a newer drug called belantamab mafodotin, while the other uses a drug called bortezomib, which is already a common treatment. By comparing these two drug combinations, researchers hope to see if the newer approach offers better results, such as controlling the cancer more effectively or having fewer side effects.

The findings from this study are important because they can help doctors decide on the best treatment options for people with multiple myeloma that has been difficult to treat. The aim is always to find treatments that are both effective and tolerable, helping patients to live longer and feel better.

Key takeaways

  • This study compares two treatments for multiple myeloma that has come back.
  • It aims to find out if a new drug combination is more effective or safer.
  • Participants will receive either belantamab mafodotin or bortezomib, plus other standard drugs.
  • Regular hospital visits, blood tests, and scans will monitor your health.
  • Participation is voluntary, and you can withdraw at any time.
  • This research helps find better future treatments for multiple myeloma patients.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with multiple myeloma. Your cancer must have come back or not responded well to at least one previous treatment that included a drug called lenalidomide. We also need to be able to measure your cancer in some way, such as through blood or urine tests.

Your general health should be good enough to participate, meaning you can carry out most daily activities without too much difficulty. If you've had a stem cell transplant before, that's generally okay, as long as it was more than 100 days ago and you don't have any serious infections. We also need any side effects from your previous treatments to have mostly cleared up.

You would not be able to join if you have certain other conditions, like active plasma cell leukaemia, severe nerve problems, or specific organ issues that could make the treatment unsafe for you. Both men and women will need to agree to use effective contraception during the study.

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. Have you been diagnosed with multiple myeloma?
  3. Has your multiple myeloma come back or not responded to a previous treatment that included lenalidomide?
  4. Are you generally well enough to do most daily activities (ECOG 0-2)?
  5. Have any side effects from your last treatment mostly gone away?
  6. Are you willing to use contraception during the study if needed?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two treatment groups – either the group receiving belantamab mafodotin, pomalidomide, and dexamethasone, or the group receiving bortezomib, pomalidomide, and dexamethasone. The treatments involve taking medications, which could be in pill form or given as injections/infusions, depending on the specific drug.

You'll have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how the treatment is working. These visits will help the study doctors keep a close eye on your progress and any potential side effects. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be kept informed every step of the way. All participants will be carefully followed up, even after their active treatment period ends.

Potential risks and benefits

The potential benefits of joining this study include receiving close medical attention and access to a possible new treatment for your multiple myeloma that might be more effective than current approaches. However, there's no guarantee that the treatment will work for everyone, and you might experience side effects from the study drugs. These side effects can vary in severity and will be carefully monitored by your study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (119)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GSK Investigational Site
    Verified postcode
    Tucson, United States
  • GSK Investigational Site
    Verified postcode
    Fort Myers, United States
  • GSK Investigational Site
    Verified postcode
    Boston, United States
  • GSK Investigational Site
    Verified postcode
    Kansas City, United States
  • GSK Investigational Site
    Verified postcode
    Nashville, United States
  • GSK Investigational Site
    Verified postcode
    Garran, Australia
  • GSK Investigational Site
    Verified postcode
    Darlinghurst, Australia
  • GSK Investigational Site
    Unverified
    Gosford NSW, Australia
  • GSK Investigational Site
    Verified postcode
    Port Macquarie, Australia
  • GSK Investigational Site
    Verified postcode
    Benowa, Australia
  • GSK Investigational Site
    Verified postcode
    South Brisbane, Australia
  • GSK Investigational Site
    Verified postcode
    Adelaide, Australia

Common questions

What is multiple myeloma?

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

What does 'relapsed/refractory' mean?

It means your multiple myeloma has either come back after treatment (relapsed) or hasn't responded well to previous treatments (refractory).

Will I know which treatment I'm getting?

You will be assigned to one of the two treatment combinations being tested, but the study team will explain which one you receive if you are randomised to a treatment, or if the study is 'open-label'.

What are the main drugs being tested?

The study compares belantamab mafodotin with bortezomib, both in combination with pomalidomide and dexamethasone.

How long will the study last?

The length of your participation will depend on your individual response to treatment and the study schedule, which will be fully explained to you.

How to find out more

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

Discussion

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