Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT04683393
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or greater
* Newly diagnosed or relapse/refractory patients with multiple myeloma including non-secretory multiple myeloma. If patients are at diagnosis, they need to have a myeloma defining events (MDE) as reported in Appendix B. If they are at relapse they need to meet the criteria for relapse as per Appendix C.
* Patients due to start any anti-myeloma treatment irrespectively from the line of treatment
* Able to provide written informed consent
* Patients enrolled in other clinical trials can be enrolled in this study. Patients will not attend the hospital more frequently if enrolled in this study. In fact all the assessment, tests and questionnaires will be done whilst the patients are attending the hospital for routine appointments.
Inclusion criteria for healthy subjects:
* Aged 50 years or greater
* Able to provide written informed consent
Exclusion Criteria:
* Not able to give informed consent
* MGUS or sMM without MDE
* Patients receiving ongoing treatment for MM with the exclusion of steroids (maximal dose of Dexamethasone 160 mg in last 2 weeks or equivalent) and radiotherapy for spinal cord compression (SCC). The reason for this exclusion is that the baseline measurements need to be done before starting a proper line of chemotherapy and not in the middle of a treatment in order to be comparable between patients.
* Patient received allogeneic stem cell transplant at any stage of treatment. The reason being that some markers (i.e. telomere length) can consistently change following an allogeneic stem cell transplant
Exclusion criteria for healthy subjects:
* Not able to give informed consent
* History of past or present cancer requiring treatment (surgery and/or radiotherapy and/or chemotherapy)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04683393
Study Brief:
Protocol Section:
NCT04683393