All studies
Active not recruitingPHASE3INTERVENTIONAL

Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

This study is for people with a rare type of bone cancer called solitary bone plasmacytoma, which is often treated with radiotherapy. While radiotherapy can help, many people find their condition can progress to a more serious cancer called multiple myeloma. This study is testing if adding two medicines, lenalidomide and dexamethasone, after radiotherapy can prevent this progression. Researchers want to see if these medicines can help people stay well for longer, compared to just having radiotherapy. The aim is to find better ways to treat this condition and improve long-term health for patients in the UK.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
University College, London
Enrolment target
36
Start
10 Mar 2017
Estimated completion
01 Dec 2026

What is this study about?

Imagine you have a specific type of bone cancer called solitary bone plasmacytoma. This means you have a small cluster of problem cells in one part of your bones. Often, doctors treat this with radiotherapy, which uses strong X-rays to kill these cells. While this treatment works well for some, for many others, this solitary cancer can eventually develop into a more widespread bone cancer called multiple myeloma. This development can happen even when the initial treatment was successful.

This study, called the IDRIS Trial, is trying to find a way to stop this progression. Researchers believe that by adding two specific medications, lenalidomide and dexamethasone, after radiotherapy, they might be able to prevent the solitary bone plasmacytoma from turning into multiple myeloma. These medicines are designed to work with your body's immune system or help control problem cells.

The main goal is to see if people who receive these extra medications stay free from multiple myeloma for a longer time compared to those who only have radiotherapy. By understanding this, doctors hope to offer better long-term treatment strategies and improve the health and well-being of patients in the UK who have this condition.

Key takeaways

  • New study for people with solitary bone plasmacytoma.
  • Investigating if extra medicines after radiotherapy can prevent progression to multiple myeloma.
  • Compares medicines (lenalidomide + dexamethasone) with standard follow-up.
  • Aims to improve long-term health and prevent cancer spread.
  • Participation involves regular check-ups and monitoring.
  • You can withdraw at any time.

Who may be eligible?

To be part of this study, you must have been recently diagnosed with solitary bone plasmacytoma and have finished your radiotherapy treatment within the last 28 days. You need to be at least 18 years old and in reasonably good health, able to manage everyday activities without too much trouble.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to many places, or if it's outside your bones, this study wouldn't be right for you. You also couldn't take part if you have certain other conditions, like severe liver or kidney problems, or uncontrolled diabetes. If you're pregnant or breastfeeding, or have a high risk of blood clots, you also wouldn't be able to join. The study team will check all these details carefully with you and your doctor.

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. Have I recently been diagnosed with solitary bone plasmacytoma?
  2. Did I finish my radiotherapy treatment within the last 28 days?
  3. Am I at least 18 years old?
  4. Am I generally well enough to go about my daily life?
  5. Do I not have multiple areas of cancer (like multiple myeloma)?
  6. Do I not have severe kidney or liver problems?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: one group will receive the medicines lenalidomide and dexamethasone after their radiotherapy, and the other group will only continue with standard follow-up after radiotherapy. You'll have regular hospital visits, likely including blood tests, physical examinations, and possibly scans, to check how you're responding to treatment and monitor your health. The study team will provide you with the medications if you are in that group and explain exactly how to take them. You will be closely followed for a period of time to see how your condition progresses.

For women, if you are able to become pregnant, you'll need to agree to use effective contraception as part of a pregnancy prevention program because the study medicines can be harmful to a developing baby. The total duration of your participation, including follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in this study may offer some potential benefits. You might receive a treatment that could help prevent your solitary bone plasmacytoma from developing into multiple myeloma, which could improve your long-term health. However, there are also potential risks; the study medicines can cause side effects, and some known ones include an increased risk of blood clots. The study team will monitor you closely for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal United Hospital
    Verified postcode
    Bath, United Kingdom
  • Blackpool Victoria Hospital
    Verified postcode
    Blackpool, United Kingdom
  • University Hospital Wales
    Verified postcode
    Cardiff, United Kingdom
  • Velindre Cancer Centre
    Verified postcode
    Cardiff, United Kingdom
  • Beatson West of Scotland Cancer Centre
    Verified postcode
    Glasgow, United Kingdom
  • St James University Hospital
    Verified postcode
    Leeds, United Kingdom
  • University College London Hospital
    Verified postcode
    London, United Kingdom
  • The Christie Hospital
    Verified postcode
    Manchester, United Kingdom
  • Freeman Hospital
    Verified postcode
    Newcastle, United Kingdom
  • Mount Vernon Cancer Centre
    Verified postcode
    Northwood, United Kingdom
  • Royal Preston Hospital
    Verified postcode
    Preston, United Kingdom
  • Salisbury District Hospital
    Verified postcode
    Salisbury, United Kingdom

Common questions

What is solitary bone plasmacytoma?

It's a rare type of cancer where a small group of abnormal cells grows in one part of your bone.

What is multiple myeloma?

It's a more serious cancer where these abnormal cells spread throughout your bone marrow.

What are lenalidomide and dexamethasone?

These are medicines that can affect your immune system or help control cancer cells.

Will I definitely get the new medicines?

No, you'll be randomly put into one of two groups; one gets the medicines, the other gets standard care.

Can I stop participating in the study?

Yes, you can decide to leave the study at any time, and it won't affect your regular medical care.

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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