All studies
Active not recruitingPHASE2INTERVENTIONAL

Carfilzomib/Cyclophosphamide/Dexamethasone with Maintenance Carfilzomib in Multiple Myeloma

The Cardamon study is testing a new approach for people with multiple myeloma, a type of cancer that affects the bone marrow. It uses existing chemotherapy drugs, cyclophosphamide and dexamethasone, alongside a newer drug called Carfilzomib. Normally, younger, fitter patients have chemotherapy followed by a stem cell transplant using their own cells. However, newer drug combinations are proving very effective, leading doctors to question if an immediate stem cell transplant is always the best first step. This study will compare patients who receive a stem cell transplant early with those who get more drug treatment instead. All patients will also receive ongoing maintenance treatment to help keep the cancer under control. The aim is to find out which treatment path offers the best outcomes for patients.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
University College, London
Enrolment target
281
Start
16 Jun 2015
Estimated completion
01 Nov 2029

What is this study about?

The Cardamon study is looking for better ways to treat multiple myeloma, which is a cancer that affects the cells in your bone marrow. When someone is diagnosed with multiple myeloma and they are young and fit enough, the usual treatment starts with chemotherapy. This is often followed by a special procedure called a stem cell transplant, where doctors use your own healthy stem cells after high-dose chemotherapy. While this approach helps many people, unfortunately, the cancer often comes back after some time.

Recently, new and improved chemotherapy treatments have become available. These new drugs are much better at reducing the cancer and can lead to very good results, sometimes even making the cancer almost undetectable. Because these new treatments are so effective, doctors are now wondering if it's always best to have a stem cell transplant right after the first round of chemotherapy. It might be better to save the stem cells for later, perhaps if the cancer returns, and continue with drug treatment instead.

This study aims to answer that question. Patients will first receive the new drug combination (Carfilzomib, cyclophosphamide, and dexamethasone) and have their stem cells collected and stored. Then, they will be randomly assigned to one of two groups: one group will have the stem cell transplant straight away, and the other group will continue with more drug treatment (called consolidation therapy) instead of the transplant. All patients will then receive ongoing treatment to help prevent the cancer from coming back. By comparing these two approaches, the study hopes to find out which method gives patients the best chance of a long and healthy life.

Key takeaways

  • This study compares two ways of treating multiple myeloma after initial therapy.
  • It uses a new drug, Carfilzomib, with standard treatments.
  • One group will have an early stem cell transplant, the other will get more drug treatment.
  • All participants will receive ongoing maintenance treatment.
  • It aims to find the best long-term outcome for patients.
  • Your health will be closely monitored throughout.

Who may be eligible?

This study is looking for adults aged 18 or over who have been newly diagnosed with multiple myeloma and haven't started treatment yet, except for some basic care like pain relief or certain bone-strengthening medicines. You need to be fit enough to have a stem cell transplant, even if you don't end up having one in the study.

To join, your multiple myeloma needs to be at a stage where doctors can measure it, either through blood or urine tests, or by looking at your bone marrow. Your general health also needs to be good enough to take part. This includes having good liver, kidney, blood cell, and platelet counts, which will be checked through blood tests. Your doctor will also look at your overall fitness level.

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 newly diagnosed with multiple myeloma and not yet started treatment (except for pain relief)?
  3. Are you generally fit enough for a stem cell transplant?
  4. Do you have good overall health, including healthy liver, kidney, and blood cell counts?
  5. Can your doctor measure your myeloma through blood, urine, or bone marrow tests?
Answer every question to see your result.

What does participation involve?

If you join the Cardamon study, you will first receive a combination of drugs (Carfilzomib, cyclophosphamide, and dexamethasone) for a set period. During this time, your healthy stem cells will be collected and stored. After this, you will be randomly placed into one of two treatment groups: you might either have a stem cell transplant, or you might receive more drug treatment called 'consolidation therapy'. Following this, all participants will receive ongoing 'maintenance' treatment with Carfilzomib to help keep your myeloma under control for a longer period.

Throughout the study, you will have regular hospital visits for check-ups, blood tests, and to receive your treatment. The total duration of your participation, including treatments and follow-up, will be discussed by your doctor, but it typically involves several months of active treatment followed by maintenance therapy and monitoring over a longer period.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving a newer treatment combination which might be more effective in controlling your multiple myeloma. However, all medical treatments carry potential risks, such as side effects from the drugs (which your doctor will explain) or risks associated with the stem cell transplant procedure, if you are in that group. The risks and benefits will be fully explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (20)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Queen's Hospital
    Verified postcode
    Romford, United Kingdom
  • Royal United Hospital
    Verified postcode
    Bath, United Kingdom
  • Birmingham Heartlands Hospital
    Verified postcode
    Birmingham, United Kingdom
  • NHS Lanarkshire
    Verified postcode
    Bothwell, United Kingdom
  • Bradford Royal Infirmary
    Verified postcode
    Bradford, United Kingdom
  • Kent and Canterbury Hospital
    Verified postcode
    Canterbury, United Kingdom
  • University Hospital of Wales
    Verified postcode
    Cardiff, United Kingdom
  • Medway NHS Foundation Trust
    Verified postcode
    Gillingham, United Kingdom
  • St James' Hospital
    Verified postcode
    Leeds, United Kingdom
  • St Bartholomew's Hospital
    Verified postcode
    London, United Kingdom
  • Barnet Hospital
    Verified postcode
    London, United Kingdom
  • Guy's Hospital
    Verified postcode
    London, United Kingdom

Common questions

What is multiple myeloma?

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

What is a stem cell transplant?

It's a procedure where doctors use your own healthy stem cells, collected earlier, to help your body recover after receiving very strong anti-cancer treatment.

What does 'randomly allocated' mean?

It means you will be assigned to a treatment group by chance, like flipping a coin, to ensure fairness and accurate comparison between treatments.

What is 'maintenance treatment'?

This is treatment given over a longer period, usually at a lower dose, after initial intensive therapy, to help keep the cancer from returning or growing.

Will I still get treatment if I don't get the transplant?

Yes, if you're not in the transplant group, you'll receive 'consolidation therapy,' which is another form of drug treatment, followed by maintenance treatment.

How to find out more

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

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