A "Physician & Patient-powered" Cohort Registry (MY MYELOMA) (MY MYELOMA)
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|ClinicalTrials.gov Identifier: NCT05001087|
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : August 11, 2021
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Other: Observation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1900 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||A "Physician & Patient-powered" Cohort Registry|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||March 1, 2024|
Non-interventional, multicentre, retrospective and prospective registry. In order to increase the sample size and the validity of the Registry, patients who were diagnosed with myeloma since 1st January 2019 will also be included retrospectively, once their informed consent has been obtained by the enrolling centre. Being a registry, patients will be enrolled consecutively according to their appointments at the centre, at the discretion of their doctor and only once the patient has signed the informed consent form.
Also patients participating in interventional or other observational studies can be enrolled. In case of patients enrolled in interventional trials, only baseline and survival data can be collected for the period in with the patient is in interventional trial.
The data will be collected using an electronic data capture (EDC) platform. Hospital visits are planned every 6 months.
Not applicable-Observational study
- Overall survival (OS) [ Time Frame: 3 years ]Time between diagnosis and death.
- Time to next treatment (TTNT) [ Time Frame: 3 years ]Time to next treatment will be measured from the screening to the date of next anti-myeloma therapy, for each treatment regime.
- Patient reported outcomes (PROs) [ Time Frame: 3 years ]Periodic completion of the EORTC-QLQ-C30 to evaluate the quality of life of the patients.
- Costs incurred by the patients [ Time Frame: 3 years ]Evaluation of the costs incurred by the patients related to the therapy based on the different treatments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05001087
|Contact: Mario Boccadorofirstname.lastname@example.org|
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