A PLATFORM STUDY EVALUATING THE SAFETY AND EFFICACY OF MULTIPLE TREATMENTS IN PATIENTS WITH MULTIPLE MYELOMA
A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
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Cancer -
Multiple Myeloma
Basic Details
1. Why is the CO43923 SS1 study needed?
Multiple myeloma (MM) is a type of cancer that affects the bone marrow and impacts various parts of the body. Treatments have improved over the years and different types of treatments are now available, helping people to live with MM for longer. But there is no cure for MM at the current time. More research is needed to understand the disease and its treatments. This will help researchers understand where new treatments are needed.
Researchers need more information to understand:
- Which treatments are being prescribed to people for different types of MM, including if they have other health problems
- Which treatments for MM are first prescribed, and how and why treatments are changed over time
- How well prescribed treatments are tolerated – what side effects they cause and how serious they are
The study aims to collect medical information about people with multiple myeloma and the different treatments they are prescribed over time.
2. How does the CO43923 SS1 study work?
This study is recruiting people with MM. People can take part if they are being given routine treatment for MM at a clinical trial site for a Roche-sponsored trial known as ‘CO43923’.
People who take part in this study (participants) will not be given clinical trial treatment. Participants will receive standard treatment for their MM and will be followed-up regularly, in the usual way outside of a clinical study, by their doctor. Information on the participant and their disease will be collected, including blood and bone marrow tests, scan results (imaging), genetic test results, treatments given and side effects. The total time of participation in the study will be up to 20 years. Participants can leave the study at any time, and their routine medical care will not be affected.
3. What are the main endpoints of the study?
The main study endpoints (the main results measured in the study) are to understand:
- Which treatments are prescribed for MM and in what order, over time
- How well prescribed treatments work, measured by:
- the number of participants with no detectable cancer, or at least a 90% or 50% reduction in cancer after starting routine treatment
- the amount of time between the start of treatment and participants cancer worsening
- the amount of time taken to first respond to treatment and to the best response seen to treatment in participants with at least a 50% reduction in cancer
- the number of participants with no detectable MM in bone marrow (and which test is used)
- how long participants live
- The number and seriousness of side effects
Other information that will be collected in the study includes:
- Participants’ age, sex, race/ethnicity
- Other medical conditions and medicines being taken
- Past and current blood test and scan results
- Genetic information on their MM
4. Who can take part in this study?
People can take part in this trial if they have been diagnosed with MM and are under the care of a doctor at a site where the clinical trial CO43923 is taking place.
People may not be able to take part in this trial if they do not agree for their information to be stored and used (processed) for research purposes.
5. What treatment will participants be given in this study?
Everyone who joins this clinical trial will be given routine medical care for their MM. No experimental treatments will be given in this study.
6. Are there any risks or benefits in taking part in this study?
People who would like to participate will be told about any risks and benefits of routine medical care. In addition, people will be told how their information and medical samples will be used, how long they will be kept for, and how their personal information will be protected. All of these will be described in an informed consent document (a document that provides people with the information they need to decide to volunteer for the clinical trial).
Risks associated with the study
Participants’ personal and medical information will be securely stored to minimise the risk of it being seen by unauthorised people.
Potential benefits associated with the study
Participants will not be given clinical trial treatment beyond their usual MM treatment; people will be treated for MM in the same way if they take part in the study or not – so participants' health will not improve from participation in the study. Still, the information collected may help other people with similar medical conditions in the future by helping researchers understand MM better.
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
For the latest version of this information please go to www.forpatients.roche.com