A Study of Real Life Treatment for Multiple Myeloma (MM) (NCT04985643) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of Real Life Treatment for Multiple Myeloma (MM)
Russia357 participantsStarted 2022-02-18
Plain-language summary
The main aim of this study is to learn how long it takes for people with MM to have a relapse after their first treatment. Not all participants will have a relapse during the study.
Participants will visit their clinic every 3 months and be treated according to their clinic's standard practice.
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. With newly diagnosed multiple myeloma (NDMM) eligible and non-eligible for a high-dose therapy and autologous stem cell transplantation (HDT-ASCT) who have had a response (defined as CR, VGPR, or PR) to the ongoing SoC induction (1st line) therapy that has been started within 3 months before the inclusion.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of inclusion.
Exclusion criteria
. With NDMM eligible and non-eligible for a HDT-ASCT who have had SD or PD to the ongoing standard of care (SoC) induction (1st line) therapy that has been started within 3 months before the inclusion.
. Current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is observational and is tracking how long it takes for multiple myeloma to show signs of coming back after first-line treatment in real-world patients — does my current treatment plan align with what's being studied here, and could the findings from this research actually influence my care?
2Since this trial is no longer enrolling new participants, are there similar ongoing observational studies or registries I could join that would give researchers data about my real-world treatment experience?
3This study is measuring 'biochemical relapse,' which means a change in lab markers before symptoms return — how will my care team be monitoring me for those early signs, and how often will I need blood or urine tests to track them?
4Because this is a real-world observational study rather than a randomized trial testing a new drug, what are the evidence-based treatment options my doctor currently recommends for my specific type and stage of multiple myeloma?
5How do the real-world outcomes being captured in studies like this one compare to what was seen in the clinical trials that led to my recommended treatment, and does that affect how confident my doctor is in my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM
Timeframe: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)