Myeloma Registry Platform (MYRIAM) (MYRIAM)
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|ClinicalTrials.gov Identifier: NCT03308474|
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : March 1, 2021
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Other: Routine care as per site standard.|
MYRIAM is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of multiple myeloma in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
Health-realted quality of life in patients with multiple myeloma (MyLife) will be evaluated for up to five years.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2100 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)|
|Actual Study Start Date :||September 25, 2017|
|Estimated Primary Completion Date :||December 2026|
|Estimated Study Completion Date :||December 2027|
- Other: Routine care as per site standard.
Physician's choice according to patient's needs.
- Course of treatment (treatment reality) [ Time Frame: 5 years per patient ]Documentation of anamnestic data and therapy sequences
- Best Response [ Time Frame: 5 years per patient ]Documentation of response rates per line of treatment.
- Progression-free survival [ Time Frame: 5 years per patient ]Documentation of progression-free survival per line of treatment.
- Overall survival [ Time Frame: 5 years per patient ]Documentation of overall survival time.
- Health-related quality of life (Patient-reported outcome) [ Time Frame: 5 years per patient ]EORTC QLQ-C30 core questionnaire.
- Myeloma-specific health-related quality of life (Patient-reported outcome) [ Time Frame: 5 years per patient ]EORTC QLQ-MY20, the myeloma specific module.
- Quality of life (Patient-reported outcome) [ Time Frame: 5 years per patient ]Brief Pain Inventory (BPI)
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): NCT03308474
|Contact: Martina Jänicke, PhD||+49 761 email@example.com|
|Multiple sites all over germany||Recruiting|
|Multiple Locations, Germany|
|Contact: iOMEDICO AG +49 761 152420 firstname.lastname@example.org|
|Study Chair:||Hermann Einsele, Prof MD||Wuerzburg University Hospital|
|Study Chair:||Monika Engelhardt, Prof MD||Universitätsklinikum Freiburg|
|Study Chair:||Tobias Dechow, Prof MD||Onkologie Ravensburg|
|Study Chair:||Wolfgang Knauf, Prof MD||Centrum für Hämatologie und Onkologie Bethanien|
|Study Chair:||Norbert Marschner, MD||Praxis für interdisziplinäre Onkologie & Hämatologie|