All studies
Active not recruitingOBSERVATIONAL

A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

This study is for people in the UK who have multiple myeloma, a type of blood cancer, that has come back or isn't responding to past treatments. It's called an "observational study," which means doctors are watching how a medicine called isatuximab is used in everyday practice, rather than testing a new treatment or specific plan. They want to see how effective it is over 12 months, including how many people respond to it and for how long. The study also looks at how safe isatuximab is and how it affects patients' quality of life. Participants will be aged 18 or over and will already be taking, or about to start taking, isatuximab as part of their regular care.

At a glance

Status
Active not recruiting
Sponsor
Sanofi
Enrolment target
583
Start
13 Aug 2020
Estimated completion
23 Feb 2026

What is this study about?

This study is designed to understand how a medicine called isatuximab works in real life for adults in the UK who have a type of blood cancer called multiple myeloma. This is specifically for patients whose cancer has either returned after previous treatment (relapsed) or hasn't responded to earlier treatments (refractory).

Doctors want to observe how effective isatuximab is in these patients. This includes checking how many people respond to the treatment within 12 months and how long that response lasts. They also want to understand the safety of isatuximab by looking at any side effects people experience. A key part of the study is also to see how the treatment affects patients' daily lives and well-being, often called 'quality of life'.

This is an "observational study," meaning you won't be given a specific treatment plan for the study. Instead, doctors will observe how patients are already being treated with isatuximab as part of their standard care. The study aims to gather important information that can help doctors understand this medicine better for future patients.

Key takeaways

  • This is an observational study about a known multiple myeloma drug, isatuximab.
  • It aims to see how well isatuximab works and how safe it is for patients in the UK.
  • Participation involves tracking your existing treatment and completing questionnaires.
  • The study is for adults whose multiple myeloma has returned or isn't responding to prior treatments.
  • Your doctor will decide if isatuximab is right for you, independently of this study.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You should have multiple myeloma that has come back or isn't responding to previous treatments. Importantly, you must either be about to start taking isatuximab as part of your regular medical care, or have already started it within the last three months, based on your doctor’s decision and not because of the study itself.

There are also some reasons why you might not be able to join. For example, you can't be in the study if you're taking isatuximab for a different health problem or if you've recently taken another experimental drug. You also can't participate if you have any health conditions that would make taking isatuximab unsafe for you, as listed in the medicine's official information.

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. Am I 18 years old or older?
  2. Do I have multiple myeloma that has come back or isn't responding to past treatments?
  3. Has my doctor decided I should take isatuximab, or have I started it within the last three months?
  4. Am I able to understand and complete simple questionnaires about my health?
  5. Do I have any other health conditions that would make taking isatuximab unsafe for me?
Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last for about two and a half years (2.5 years). You won't be asked to change your current treatment plan with isatuximab; doctors will simply observe your progress as you receive your standard care. This means your appointments and medication schedule will be as agreed with your own doctor.

During this time, you will be asked to complete some questionnaires about your health and how you're feeling, including questions about your quality of life. Doctors will also collect information about your general health, your multiple myeloma, and any other health conditions you might have. They will also record any side effects you experience while taking isatuximab. These activities will generally happen during your regular clinic visits.

Potential risks and benefits

Participating in this study might offer a small benefit by allowing your doctors to monitor your treatment closely, providing detailed information about your health and progress during your treatment with isatuximab. The main risks are generally low, as you will be receiving treatment your doctor has already decided is best for you, and the study involves collecting information rather than new interventions. Any side effects you experience will be related to the isatuximab treatment itself, which your doctor will manage. You are free to withdraw from the study at any time without affecting your medical care.

Locations (129)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Arkansas Medical Sciences Site Number : 8400021
    Verified postcode
    Little Rock, United States
  • St. Joseph Heritage Healthcare Site Number : 8400008
    Verified postcode
    Fullerton, United States
  • University of California San Francisco (PARENT) Site Number : 8400009
    Verified postcode
    San Francisco, United States
  • Holy Cross Hospital Site Number : 8400030
    Verified postcode
    Fort Lauderdale, United States
  • GenesisCare Site Number : 8400007
    Verified postcode
    Jacksonville, United States
  • Watson Clinic Cancer and Research Center Site Number : 8400023
    Verified postcode
    Lakeland, United States
  • Millennium Oncology Site Number : 8400025
    Verified postcode
    Pembroke Pines, United States
  • Comprehensive Hematology Oncology Site Number : 8400026
    Verified postcode
    St. Petersburg, United States
  • Central Care Cancer Center Site Number : 8400019
    Verified postcode
    Garden City, United States
  • Central Maine Medical Center Site Number : 8400031
    Verified postcode
    Lewiston, United States
  • Michigan Center of Medical Research Site Number : 8400010
    Verified postcode
    Farmington Hills, United States
  • Central Care Cancer Center Site Number : 8400006
    Verified postcode
    Garden City, United States

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 your bone marrow. These cells help fight infection, but in multiple myeloma, they grow abnormally.

What is isatuximab?

Isatuximab is a medicine used to treat multiple myeloma. It works by targeting specific proteins on the cancer cells to help your immune system fight them.

Will I receive new medicine in this study?

No, you will not receive new or experimental medicine. This study observes how isatuximab, which your doctor has already decided is right for you, works in real-world settings.

What does 'relapsed and/or refractory' mean?

Relapsed means your multiple myeloma has come back after treatment. Refractory means your cancer did not respond to previous treatments.

How long will I be involved in the study?

If you participate, the study will follow your progress for about two and a half years (2.5 years).

How to find out more

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

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